Parkinson's DiseaseNCT01956032
Duodopa Home Titration Using Telemedicine: Evaluation of Use of Resources
An observational study of Parkinson's Disease, run by AbbVie.
Trial summary
The purpose of this study was to evaluate the use of resources during titration of Duodopa at home. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Parkinson's Disease
- Type of treatment
- Pill or oral medicine
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- Sep 2013to Nov 2014
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants with advanced Parkinson's disease admitted to movement disorder specialty clinics
Who may be able to join
- Suitable for Duodopa treatment in accordance with the Swedish Summary of Product Characteristics
- Motivated and confident to test Duodopa home titration using TM
- Participants who were able to handle the infusion pump and the TM equipment by themselves or with assistance, as determined by the Investigator
- Understood and signed the study informed consent form
Who cannot join
- Dementia or cognitive decline with Mini Mental State Examination score less than 24
- Ongoing symptomatic depression, hallucinations or other psychotic behaviors without adequate treatment, as determined by the Investigator
- Contraindications as described in the Swedish Summary of Product Characteristics: hypersensitivity to levodopa or carbidopa, narrow angle glaucoma, serious liver and kidney disease, severe heart failure, acute myocardial infarction, severe cardiac arrhythmias, recent or acute stroke, contraindications for adrenergic effects; pheochromocytoma, hyperthyroidism, cushing's syndrome, and other contraindications for abdominal surgery
- Other reasons that made the participant unsuitable for home titration using TM, as determined by the Investigator
About this study
Official title: Levodopa Carbidopa Intestinal Gel Home Titration Using Telemedicine: Evaluation of Use of Resources
The purpose of this study was to evaluate the use of resources during titration of Duodopa at home.
Read the detailed description
Telemedicine (TM) offers an alternative titration procedure allowing the start of Duodopa infusion at home. The study evaluated the use of resources, measured as the number of contacts and time spent by health care professionals (Duodopa nurse specialists and the study Investigators) and the TM technician, during Duodopa infusion at home. Data was collected from four (4) clinical centers in Sweden. Data collection period for each participant started at the decision to administer Duodopa treatment (Baseline) and ended when the Duodopa titration period was complete. Post-titration, the participants and caregiver were interviewed and the investigators and nurses answered a web based questionnaire on their experiences.
- Conditions
- Parkinson's Disease
- Keywords
- LCIG, Parkinson's disease, levodopa carbidopa intestinal gel, Telemedicine
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Participants with Parkinson's disease | Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics. Other name for Duodopa is Levodopa Carbidopa Intestinal Gel (LCIG). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median Time Used by Investigator, Duodopa Nurse Specialist, Telemedicine (TM) Technician, and Participant
Health care professional time was defined as the number of minutes the individual had contact with the participant visiting their home, assisting with TM equipment, or by telephone. TM technician time was defined as the number of minutes spent for setup, demounting, and adjustments to the TM equipment. Data are presented as the time in minutes for communication between the following individuals and summarized by the type of contact (all types, TM, telephone, home visit, and other): (1) Participant + Investigator time; (2) Participant + DNS time; (3) Participant + Investigator + DNS time; (4) Participant + TM technician time; (5) Total Investigator time; (6) Total DNS time; and (7) Total participant time.
Measured: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Median Number of Contacts
Contacts (total, TM, telephone, home visit, and other) during the study period between the participant, the health care professional (the DNS and the Investigator) and TM technician were counted and summarized by type. Data are presented as number of contacts per participant with a minimum and maximum range.
Measured: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Secondary outcomes (42)
Median Total Time for Titration
The total time for titration period was defined as the number of minutes from the start of the pump after application of the naso-jejunal tube (Day 1) until Investigator's decision to terminate Duodopa treatment. Data are presented as time in minutes per participant with a minimum and maximum range.
Measured: From Day 1 (start of the pump after application of the naso-jejunal tube) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Median Total Free Time of Participant
Participant's daily free time was a maximum 24 hours, and was defined as the time spent on activities (e.g. work, household, chores, leisure time, travel, sleep, etc.) other than time spent on health care professional (the DNS and the Investigator) communication, dose adjustments and pump handling. Time for dose adjustments, health care professional communication via TM and pump handling were subtracted from the amount of participant's daily free time. The participant was asked to note the time used for independent dose adjustments and pump handling in a participant diary. Participant's total free time was calculated as the sum of participant's daily free time for all days during the titration period. Data are presented as time in minutes per participant with a minimum and maximum range.
Measured: From Day 1 (start of the pump after application of the naso-jejunal tube) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Percentage of Participants Who Experienced Technical Events
Technical events were defined as: any technical event; type A: TM equipment - mishandling; type B: TM equipment - intentional misuse; type C: TM equipment - technical problem; and type D: TM digital link. Technical problems were defined as: failure to answer video call, Intentional failure to answer video call, mechanical, electrical, failure to establish connection, interruptions, transmission quality, sound quality, image quality, and others. The percentage was calculated based on the number of participants in the FAS population.
Measured: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Incidence of Technical Events Experienced by Participants
Technical events were defined as: any technical event; type A: TM equipment - mishandling; type B: TM equipment - intentional misuse; type C: TM equipment - technical problem; and type D: TM digital link. Technical problems were defined as: failure to answer video call, Intentional failure to answer video call, mechanical, electrical, failure to establish connection, interruptions, transmission quality, sound quality, image quality, and others. The percentage was calculated based on the total number of technical events (34).
Measured: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Percentage of Participants With Consequences
Consequences due to technical events were defined as: any consequence, contact delay, re-establishment of connection, TM-call replaced by telephone call, failed scheduled contact, and other consequence. Data are summarized by type of technical event (type A: TM equipment - mishandling; type B: TM equipment - intentional misuse; type C: TM equipment - technical problem; and type D: TM digital link) and the percentage was calculated based on the number of participants in the FAS population.
Measured: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Incidence of Consequences Due to Technical Events
Consequences due to technical events were defined as: any consequence, contact delay, re-establishment of connection, TM-call replaced by telephone call, failed scheduled contact, and other consequence. Data are summarized by type of technical event (type A: TM equipment - mishandling; type B: TM equipment - intentional misuse; type C: TM equipment - technical problem; and type D: TM digital link) and the percentage was calculated based on the total number of consequences (43).
Measured: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Percentage of Participants Who Experienced Technical Events, Summarized by Type of Consequence
Technical events were defined as: any technical event; type A: TM equipment - mishandling; type B: TM equipment - intentional misuse; type C: TM equipment - technical problem; and type D: TM digital link). Data are summarized by type of consequence (contact delay, re-establishment of connection, TM-call replaced by telephone call, failed scheduled contact, and other consequence) and the percentage was calculated based on the number of participants in the FAS population.
Measured: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Incidence of Technical Events Experienced by Participants, Summarized by Type of Consequence
Technical events were defined as: any technical event; type A: TM equipment - mishandling; type B: TM equipment - intentional misuse; type C: TM equipment - technical problem; and type D: TM digital link). Data are summarized by type of consequence (contact delay, re-establishment of connection, TM-call replaced by telephone call, failed scheduled contact, and other consequence) and the percentage was calculated based on the total number of technical events (34).
Measured: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 1: How Satisfied Were You With Using TM When Starting Duodopa?
The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant on a scale from 1 to 7 for question number 1 (How satisfied were you with using TM when starting Duodopa?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.
Measured: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Positive Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 2: Did You do Things When at Home That You Could Not Have Done if You Were Hospitalized During the Titration?
The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant as 'yes' or 'no' for question number 2 (Did you do things when at home that you could not have done if you were hospitalized during the titration?) where 'yes' indicated a positive answer. Data are presented as percentage of participants with positive experience, calculated based on the number of participants in FAS with complete information.
Measured: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 3: How Easy Was the TM Equipment to Use?
The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant on a scale from 1 to 7 for question number 3 (How easy was the TM equipment to use?) where 1 was 'very hard' and 7 was 'very easy'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.
Measured: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 4: How Satisfied Were You With the Video Conversation With Your Investigator?
The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant on a scale from 1 to 7 for question number 4 (How satisfied were you with the video conversation with your Investigator?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.
Measured: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 5: How Satisfied Were You With the Video Conversation With Your DNS?
The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant on a scale from 1 to 7 for question number 5 (How satisfied were you with the video conversation with your DNS?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.
Measured: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 6: How Satisfied Were You With the 3-part Video Conversations (Both Investigator and DNS)?
The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant on a scale from 1 to 7 for question number 6 (How satisfied were you with the 3-part video conversations with Investigator and DNS?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.
Measured: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 7: How Satisfied Were You With the Amount of Time the DNS Were at Your Home?
The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant on a scale from 1 to 7 for question number 7 (How satisfied were you with the amount of time the DNS were at your home?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.
Measured: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 8: How Satisfied Were You With Having the Technical Equipment in Your Home?
The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant on a scale from 1 to 7 for question number 8 (How satisfied were you with having the technical equipment in your home?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.
Measured: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 9: How Satisfied Were You With the Technician's Visits to Set up and Dismantle the TM Equipment?
The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant on a scale from 1 to 7 for question number 9 (How satisfied were you with the technician's visits to set up and dismantle the TM equipment?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.
Measured: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 10: How Confident do You Feel Regarding the Pump and the Dose Adjustments?
The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant on a scale from 1 to 7 for question number 10 (How confident do you feel regarding the pump and the dose adjustments?) where 1 was ' very unconfident' and 7 was 'very confident'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.
Measured: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 11: How Secure Did You Feel Being at Home and Communicating by TM, When Titrating Duodopa?
The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant on a scale from 1 to 7 for question number 11 (How secure did you feel being at home and communicating by TM, when titrating Duodopa?) where 1 was 'very unsecure' and 7 was 'very secure'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.
Measured: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Positive Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 12: Knowing What You Know Now, Would You Rather Have Stayed in the Hospital to Start Duodopa Treatment?
The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the participant as 'yes' or 'no' for question number 12 (Knowing what you know now, would you rather have stayed in the hospital to start Duodopa treatment?) where 'No' indicated a positive answer. Data are presented as percentage of participants with positive experience, calculated based on the number of participants in FAS with complete information.
Measured: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 13 for Caregiver: How Satisfied Were You With the Titration at the Participant's Home?
The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the caregiver on a scale from 1 to 7 for question number 13 (how satisfied were you with the titration at the participant's home?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.
Measured: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Positive Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 14 for Caregiver: Where You Able to Perform Daily Activities During the Titration Period?
The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the caregiver as 'yes' or 'no' for question number 14 (Where you able to perform daily activities during the titration period?) where 'yes' indicated a positive answer. Data are presented as percentage of participants with positive experience, calculated based on the number of participants in FAS with complete information.
Measured: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 15 for Caregiver: How Confident Did You Feel About Helping With the Pump?
The experience of Duodopa home titration using TM was assessed using a sixteen item questionnaire via semi-structured interviews with the participant and caregiver (if applicable). The experience of Duodopa home titration using TM was measured by the caregiver on a scale from 1 to 7 for question number 15 (How confident did you feel about helping with the pump?) where 1 was ' Very unconfident' and 7 was 'very confident'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.
Measured: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Positive Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 16 for Caregiver: Knowing What You Know Now, Would You Rather Have Had Your Spouse in the Hospital to Start Duodopa Treatment?
From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days. The experience of Duodopa home titration using TM was measured by the caregiver as 'yes' or 'no' for question number 16 (knowing what you know now, would you rather have had your spouse in the hospital to start Duodopa treatment?) where 'No' indicated a positive answer. Data are presented as percentage of participants with positive experience, calculated based on the number of participants in FAS with complete information.
Measured: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 1: How Satisfied Were You With the TM Concept Comports With Your Clinical Needs?
The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured on a scale from 1 to 7 for question number 1 (How satisfied were you with the TM concept comports with your clinical needs?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.
Measured: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 2: How Satisfied Were You With Using TM for Communication?
The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured on a scale from 1 to 7 for question number 2 (How satisfied were you with using TM for communication?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.
Measured: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 3: How Satisfied Were You With Using TM for Clinical Assessments?
The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured on a scale from 1 to 7 for question number 3 (How satisfied were you with using TM for clinical assessments?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.
Measured: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 4: How Satisfied Were You With the Image Quality for Your Assessment of the Participant?
The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured on a scale from 1 to 7 for question number 4 (How satisfied were you with the image quality for your assessment of the participant?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.
Measured: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 5: How Satisfied Were You With the Sound Quality for Your Assessment of the Participant?
The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured on a scale from 1 to 7 for question number 5 (How satisfied were you with the sound quality for your assessment of the participant?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.
Measured: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 6: How Satisfied Were You With the User Interphase for the TM Equipment?
The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured on a scale from 1 to 7 for question number 6 (How satisfied were you with the user interphase for the TM equipment?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.
Measured: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 7: How Satisfied Were You With the Setup and Maintenance of the TM Equipment?
The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured on a scale from 1 to 7 for question number 7 (How satisfied were you with the setup and maintenance of the TM equipment?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.
Measured: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 8: How Satisfied Were You Regarding Participant Safety Using TM?
The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured on a scale from 1 to 7 for question number 8 (How satisfied were you regarding participant safety using TM?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.
Measured: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 9: How Satisfied Were You With the Participant Contact When Using TM?
The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured on a scale from 1 to 7 for question number 9 (How satisfied were you with the participant contact when using TM?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.
Measured: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Positive (Investigator and DNS) Experience of Duodopa Home Titration Using TM Assessed by Question Number 10: Did You Lack Any Dimensions in the Assessment of the Participant Using TM That You Have in the Classical Titration at Hospital?
The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured as 'yes' or 'no' for question number 10 (Did you lack any dimensions in the assessment of the participant using TM that you have in the classical titration at hospital?) where 'No' indicated a positive answer. Data are presented as percentage of participants with positive experience, calculated based on the number of participants in FAS with complete information.
Measured: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 11: Compared to Classic Titration at Hospital - How Much Time Did You Spend on TM Communication Based on Real Communication Time for Participant Contact?
The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured as 'more', 'equal' or 'less' for question number 11 (Compared to classic titration at hospital - how much time did you spend on TM communication based on real communication time for participant contact?) where 'more' indicated the most negative answer and 'less' indicated the most positive answer. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.
Measured: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 12: Compared to Classic Titration at Hospital - How Much Time Did You Spend on TM Communication Based on Booked Communication Time for Participant Contact?
The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured as 'more', 'equal' or 'less' for question number 12 (Compared to classic titration at hospital - how much time did you spend on TM communication based on booked communication time for participant contact?) where 'more' indicated the most negative answer and 'less' indicated the most positive answer. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.
Measured: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 13: Compared to Classic Titration at Hospital - How Much Time Did You Spend on TM Communication Based on Time for Other Tasks Between Contacts?
The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the Investigator and the DNS. The experience of Duodopa home titration using TM was measured as 'more', 'equal' or 'less' for question number 13 (Compared to classic titration at hospital - how much time did you spend on TM communication based on time for other tasks between contacts?) where 'more' indicated the most negative answer and 'less' indicated the most positive answer. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.
Measured: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 14: How Satisfied Were You With Replacing the Participant Home Visit With TM Communication?
The experience of Duodopa home titration using TM was assessed using multiple web-based questionnaires by the DNS. The experience of Duodopa home titration using TM was measured on a scale from 1 to 7 for question number 14 (How satisfied were you with replacing the participant home visit with TM communication?) where 1 was 'very dissatisfied' and 7 was 'very satisfied'. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.
Measured: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) in Parkinson's Disease Symptoms
CGI-I was used to document the Investigator's impression of the participant's improvement in Parkinson's Disease symptoms throughout the study. The CGI-I was measured on a 7-point scale: 1=Very much improved; 2=Much improved; 3=Minimally improved; 4=No change; 5=Minimally worse; 6=Much worse; and 7=Very much worse, where 1 through 3 indicated positive answers. Data are presented as percentage of participants, calculated based on the number of participants in FAS with complete information.
Measured: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Number of Participants With Health Care Utilization Outside the TM Care Chain, Summarized by Type of Health Care Provider
The number of participants with health care utilization outside the TM care chain was assessed and summarized by type of health care provider (general practitioner, emergency ward, other neurologist, and other).
Measured: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Number of Participants With Health Care Utilization Outside the TM Care Chain, Summarized by Type of Contact
The number of participants with health care utilization outside the TM care chain was assessed and summarized by type of contact (other, telephone, home or outpatient visit, and hospitalization).
Measured: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Median Time Spent for Health Care Utilization Outside the TM Care Chain
The time spent in minutes for health care utilization outside the TM care chain was assessed. Data are presented as time in minutes with a minimum and maximum range.
Measured: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2013 (estimated)
- Study startSep 2013
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eva Dahl, MD, Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01956032
- Sponsor's protocol ID
- P14-000
- Status last verified
- Jan 2016
- First submitted
- 30 Sep 2013
- Last updated
- 23 Feb 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Levodopa Carbidopa Intestinal Gel Home Titration Using Telemedicine: Evaluation of Use of Resources
- ClinicalTrials.gov ID
- NCT01956032
- Acronym / sponsor ID
- P14-000
- Conditions
- Parkinson's Disease
- Keywords
- LCIG, Parkinson's disease, levodopa carbidopa intestinal gel, Telemedicine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- Sep 2013
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 8 Oct 2013 (estimated)
- Results
- Posted 25 Jan 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was to evaluate the use of resources during titration of Duodopa at home.
Detailed description
Telemedicine (TM) offers an alternative titration procedure allowing the start of Duodopa infusion at home. The study evaluated the use of resources, measured as the number of contacts and time spent by health care professionals (Duodopa nurse specialists and the study Investigators) and the TM technician, during Duodopa infusion at home. Data was collected from four (4) clinical centers in Sweden. Data collection period for each participant started at the decision to administer Duodopa treatment (Baseline) and ended when the Duodopa titration period was complete. Post-titration, the participants and caregiver were interviewed and the investigators and nurses answered a web based questionnaire on their experiences.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with Parkinson's disease | – | –Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics. Other name for Duodopa is Levodopa Carbidopa Intestinal Gel (LCIG). |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with advanced Parkinson's disease admitted to movement disorder specialty clinics
Key inclusion criteria (4 listed)
- Suitable for Duodopa treatment in accordance with the Swedish Summary of Product Characteristics
- Motivated and confident to test Duodopa home titration using TM
- Participants who were able to handle the infusion pump and the TM equipment by themselves or with assistance, as determined by the Investigator
- Understood and signed the study informed consent form
Key exclusion criteria (4 listed)
- Dementia or cognitive decline with Mini Mental State Examination score less than 24
- Ongoing symptomatic depression, hallucinations or other psychotic behaviors without adequate treatment, as determined by the Investigator
- Contraindications as described in the Swedish Summary of Product Characteristics: hypersensitivity to levodopa or carbidopa, narrow angle glaucoma, serious liver and kidney disease, severe heart failure, acute myocardial infarction, severe cardiac arrhythmias, recent or acute stroke, contraindications for adrenergic effects; pheochromocytoma, hyperthyroidism, cushing's syndrome, and other contraindications for abdominal surgery
- Other reasons that made the participant unsuitable for home titration using TM, as determined by the Investigator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Median Time Used by Investigator, Duodopa Nurse Specialist, Telemedicine (TM) Technician, and Participant
Time frame: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Health care professional time was defined as the number of minutes the individual had contact with the participant visiting their home, assisting with TM equipment, or by telephone. TM technician time was defined as the number of minutes spent for setup, demounting, and adjustments to the TM equipment. Data are presented as the time in minutes for communication between the following individuals and summarized by the type of contact (all types, TM, telephone, home visit, and other): (1) Participant + Investigator time; (2) Participant + DNS time; (3) Participant + Investigator + DNS time; (4) Participant + TM technician time; (5) Total Investigator time; (6) Total DNS time; and (7) Total participant time.
Median Number of Contacts
Time frame: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Contacts (total, TM, telephone, home visit, and other) during the study period between the participant, the health care professional (the DNS and the Investigator) and TM technician were counted and summarized by type. Data are presented as number of contacts per participant with a minimum and maximum range.
42 secondary outcomes
Median Total Time for Titration
Time frame: From Day 1 (start of the pump after application of the naso-jejunal tube) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Median Total Free Time of Participant
Time frame: From Day 1 (start of the pump after application of the naso-jejunal tube) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Percentage of Participants Who Experienced Technical Events
Time frame: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Incidence of Technical Events Experienced by Participants
Time frame: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Percentage of Participants With Consequences
Time frame: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Incidence of Consequences Due to Technical Events
Time frame: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Percentage of Participants Who Experienced Technical Events, Summarized by Type of Consequence
Time frame: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Incidence of Technical Events Experienced by Participants, Summarized by Type of Consequence
Time frame: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 1: How Satisfied Were You With Using TM When Starting Duodopa?
Time frame: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Positive Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 2: Did You do Things When at Home That You Could Not Have Done if You Were Hospitalized During the Titration?
Time frame: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 3: How Easy Was the TM Equipment to Use?
Time frame: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 4: How Satisfied Were You With the Video Conversation With Your Investigator?
Time frame: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 5: How Satisfied Were You With the Video Conversation With Your DNS?
Time frame: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 6: How Satisfied Were You With the 3-part Video Conversations (Both Investigator and DNS)?
Time frame: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 7: How Satisfied Were You With the Amount of Time the DNS Were at Your Home?
Time frame: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 8: How Satisfied Were You With Having the Technical Equipment in Your Home?
Time frame: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 9: How Satisfied Were You With the Technician's Visits to Set up and Dismantle the TM Equipment?
Time frame: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 10: How Confident do You Feel Regarding the Pump and the Dose Adjustments?
Time frame: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 11: How Secure Did You Feel Being at Home and Communicating by TM, When Titrating Duodopa?
Time frame: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Positive Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 12: Knowing What You Know Now, Would You Rather Have Stayed in the Hospital to Start Duodopa Treatment?
Time frame: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 13 for Caregiver: How Satisfied Were You With the Titration at the Participant's Home?
Time frame: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Positive Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 14 for Caregiver: Where You Able to Perform Daily Activities During the Titration Period?
Time frame: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 15 for Caregiver: How Confident Did You Feel About Helping With the Pump?
Time frame: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Positive Participant Experience of Duodopa Home Titration Using TM Assessed by Question Number 16 for Caregiver: Knowing What You Know Now, Would You Rather Have Had Your Spouse in the Hospital to Start Duodopa Treatment?
Time frame: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 1: How Satisfied Were You With the TM Concept Comports With Your Clinical Needs?
Time frame: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 2: How Satisfied Were You With Using TM for Communication?
Time frame: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 3: How Satisfied Were You With Using TM for Clinical Assessments?
Time frame: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 4: How Satisfied Were You With the Image Quality for Your Assessment of the Participant?
Time frame: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 5: How Satisfied Were You With the Sound Quality for Your Assessment of the Participant?
Time frame: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 6: How Satisfied Were You With the User Interphase for the TM Equipment?
Time frame: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 7: How Satisfied Were You With the Setup and Maintenance of the TM Equipment?
Time frame: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 8: How Satisfied Were You Regarding Participant Safety Using TM?
Time frame: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 9: How Satisfied Were You With the Participant Contact When Using TM?
Time frame: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Positive (Investigator and DNS) Experience of Duodopa Home Titration Using TM Assessed by Question Number 10: Did You Lack Any Dimensions in the Assessment of the Participant Using TM That You Have in the Classical Titration at Hospital?
Time frame: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 11: Compared to Classic Titration at Hospital - How Much Time Did You Spend on TM Communication Based on Real Communication Time for Participant Contact?
Time frame: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 12: Compared to Classic Titration at Hospital - How Much Time Did You Spend on TM Communication Based on Booked Communication Time for Participant Contact?
Time frame: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Investigator and DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 13: Compared to Classic Titration at Hospital - How Much Time Did You Spend on TM Communication Based on Time for Other Tasks Between Contacts?
Time frame: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
DNS Experience of Duodopa Home Titration Using TM Assessed by Question Number 14: How Satisfied Were You With Replacing the Participant Home Visit With TM Communication?
Time frame: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) in Parkinson's Disease Symptoms
Time frame: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Number of Participants With Health Care Utilization Outside the TM Care Chain, Summarized by Type of Health Care Provider
Time frame: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eva Dahl, MD study director
AbbVie
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson's Disease, run by AbbVie.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Jan 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median Time Used by Investigator, Duodopa Nurse Specialist, Telemedicine (TM) Technician, and Participant (time frame: From Baseline (Investigator's decision to start Duodopa treatment) until End of Titration (Investigator's decision to terminate Duodopa treatment) or up to approximately 14 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2016.