Parkinson DiseaseTele-PDNCT00668551
Pilot Randomized Controlled Trial of Telemedicine for Individuals With Parkinson Disease in a Rural Population
An observational study of Parkinson Disease, run by University of Rochester at 1 site in United States.
Trial summary
To eliminate barriers (such as travel and cost) to specialized Parkinson disease (PD) care, two movement disorder specialists at the University of Rochester will be providing telemedicine visits for patients with PD who reside in the Presbyterian Home for Central New York in New Hartford, NY, or for individuals who… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to Nov 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study participants will be recruited from the Presbyterian Home Parkinson disease nursing home, assisted living, independent living, and adult day care populations, as well as the local PD support group that meets monthly at the Presbyterian Home.
Who may be able to join
- Willing and able to provide informed consent
- Age 30 years old or older
- Clinical diagnosis of idiopathic Parkinson's disease as determined by having two of the four cardinal features of PD (rest tremor, bradykinesia, cogwheel rigidity, and gait instability) and no better alternative explanation for the etiology of the symptoms
- Able to converse in English
- Willing and able to complete study requirements
Who cannot join
- Any neurological, medical, or psychiatric condition that would preclude the patient having the ability to provide informed consent or to participate in the telemedicine visit.
Trial locations and contacts
1 site in 1 country.
United States1 site
Presbyterian Home for Central New York, Inc.
New Hartford, New York, 13413
About this study
To eliminate barriers (such as travel and cost) to specialized Parkinson disease (PD) care, two movement disorder specialists at the University of Rochester will be providing telemedicine visits for patients with PD who reside in the Presbyterian Home for Central New York in New Hartford, NY, or for individuals who participate in the local support group that meets at the nursing home. Participants will attend 3 telemedicine visits at the Presbyterian Home over the course of 6 months.
We hypothesize that this telemedicine model will in time improve access to care and hence the quality of life and quality of care of individuals with PD.
Read the detailed description
Study participants are recruited from the Presbyterian Home and from the Central New York Parkinson Support Group. Anyone interested will attend a screening and baseline visit at the Presbyterian Home, where they will receive baseline surveys and a motor assessment. Eligible participants will be randomized to receive either telemedicine or standard of care.
Each telemedicine visit (Month 1, Month 3, Month 6) will take place in a 1:1 fashion between the study participant and the physician investigator - one of two movement disorder specialists from the University of Rochester - via televideo linkage, and will last approximately 30-60 minutes. The study participant will be observed by the physician investigator and she/he will be accompanied by a Presbyterian Home staff member to ensure safety throughout the telemedicine visit. The visit will be structured much the same as a standard clinical visit and will include:
- Study participant's update on his or her clinical condition
- Review of current medications, which will be provided in advance of the visit
- Review and update of medical and social histories
- Vital signs, including weight (provided by the Presbyterian Home staff)
- Pertinent neurological exam, including a modified motor examination led by physician investigator
- Assessment of current clinical state
- Dictated recommendations including a letter to the attending physician for ongoing clinical care, including changes to the PD medications
Participants assigned to the control group will receive their care as routinely scheduled with their own primary care physician and/or neurologist.
Staff members from the University of Rochester will return to the Presbyterian Home within one month of the six month study to complete final assessments with all study participants. These will include:
- Reportable events form
- Health care events form
- Quality of life and healthcare evaluation surveys
- Continuation of care survey
- 1:1 interviews
- Telemedicine focus groups
- Conditions
- Parkinson Disease
- Keywords
- Parkinson disease, 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 |
|---|---|---|
| 1 | Telemedicine care | |
| 2 | Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
The feasibility of telemedicine, based on participant ability to complete 75% or more of the trial visits.
Measured: 6 months
Secondary outcomes (5)
Parkinson's Disease Questionnaire-39 (PDQ-39)
Measured: 6 months
EuroQol (EQ-5D)
Measured: 6 months
Geriatric Depression Scale Short Form (GDS-15)
Measured: 6 months
Modified Group Health Association of America's Consumer Satisfaction Survey (GHAA)
Measured: 6 months
Qualitative assessment, including a telemedicine focus group and 1:1 interviews with study participants
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2008 (estimated)
- Study startApr 2008
- Primary completionNov 2008
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by University of RochesterThe 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- Presbyterian Homes & Services
- Investigators
- E. Ray Dorsey, MD, MBA, Principal investigator, University of RochesterKevin Biglan, MD, MPH, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00668551
- Sponsor's protocol ID
- RSRB00022923
- Acronym
- Tele-PD
- Status last verified
- Apr 2009
- First submitted
- 25 Apr 2008
- Last updated
- 13 Apr 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Hubble JP, Pahwa R, Michalek DK, Thomas C, Koller WC. Interactive video conferencing: a means of providing interim care to Parkinson's disease patients. Mov Disord. 1993 Jul;8(3):380-2. doi: 10.1002/mds.870080326.
PubMed 8341308Cheng EM, Swarztrauber K, Siderowf AD, Eisa MS, Lee M, Vassar S, Jacob E, Vickrey BG. Association of specialist involvement and quality of care for Parkinson's disease. Mov Disord. 2007 Mar 15;22(4):515-22. doi: 10.1002/mds.21311.
PubMed 17260340McConnochie KM, Wood NE, Kitzman HJ, Herendeen NE, Roy J, Roghmann KJ. Telemedicine reduces absence resulting from illness in urban child care: evaluation of an innovation. Pediatrics. 2005 May;115(5):1273-82. doi: 10.1542/peds.2004-0335.
PubMed 15867035Samii A, Ryan-Dykes P, Tsukuda RA, Zink C, Franks R, Nichol WP. Telemedicine for delivery of health care in Parkinson's disease. J Telemed Telecare. 2006;12(1):16-8. doi: 10.1258/135763306775321371.
PubMed 16438773
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Randomized Controlled Trial of Telemedicine for Individuals With Parkinson Disease in a Rural Population
- ClinicalTrials.gov ID
- NCT00668551
- Acronym / sponsor ID
- Tele-PD / RSRB00022923
- Conditions
- Parkinson Disease
- Keywords
- Parkinson disease, Telemedicine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- Presbyterian Homes & Services
- Study start
- Apr 2008
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 29 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To eliminate barriers (such as travel and cost) to specialized Parkinson disease (PD) care, two movement disorder specialists at the University of Rochester will be providing telemedicine visits for patients with PD who reside in the Presbyterian Home for Central New York in New Hartford, NY, or for individuals who participate in the local support group that meets at the nursing home. Participants will attend 3 telemedicine visits at the Presbyterian Home over the course of 6 months.
We hypothesize that this telemedicine model will in time improve access to care and hence the quality of life and quality of care of individuals with PD.
Detailed description
Study participants are recruited from the Presbyterian Home and from the Central New York Parkinson Support Group. Anyone interested will attend a screening and baseline visit at the Presbyterian Home, where they will receive baseline surveys and a motor assessment. Eligible participants will be randomized to receive either telemedicine or standard of care.
Each telemedicine visit (Month 1, Month 3, Month 6) will take place in a 1:1 fashion between the study participant and the physician investigator - one of two movement disorder specialists from the University of Rochester - via televideo linkage, and will last approximately 30-60 minutes. The study participant will be observed by the physician investigator and she/he will be accompanied by a Presbyterian Home staff member to ensure safety throughout the telemedicine visit. The visit will be structured much the same as a standard clinical visit and will include:
- Study participant's update on his or her clinical condition
- Review of current medications, which will be provided in advance of the visit
- Review and update of medical and social histories
- Vital signs, including weight (provided by the Presbyterian Home staff)
- Pertinent neurological exam, including a modified motor examination led by physician investigator
- Assessment of current clinical state
- Dictated recommendations including a letter to the attending physician for ongoing clinical care, including changes to the PD medications
Participants assigned to the control group will receive their care as routinely scheduled with their own primary care physician and/or neurologist.
Staff members from the University of Rochester will return to the Presbyterian Home within one month of the six month study to complete final assessments with all study participants. These will include:
- Reportable events form
- Health care events form
- Quality of life and healthcare evaluation surveys
- Continuation of care survey
- 1:1 interviews
- Telemedicine focus groups
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Telemedicine care |
| 2 | – | –Standard of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study participants will be recruited from the Presbyterian Home Parkinson disease nursing home, assisted living, independent living, and adult day care populations, as well as the local PD support group that meets monthly at the Presbyterian Home.
Key inclusion criteria (5 listed)
- Willing and able to provide informed consent
- Age 30 years old or older
- Clinical diagnosis of idiopathic Parkinson's disease as determined by having two of the four cardinal features of PD (rest tremor, bradykinesia, cogwheel rigidity, and gait instability) and no better alternative explanation for the etiology of the symptoms
- Able to converse in English
- Willing and able to complete study requirements
Key exclusion criteria (1 listed)
- Any neurological, medical, or psychiatric condition that would preclude the patient having the ability to provide informed consent or to participate in the telemedicine visit.
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
The feasibility of telemedicine, based on participant ability to complete 75% or more of the trial visits.
Time frame: 6 months
5 secondary outcomes
Parkinson's Disease Questionnaire-39 (PDQ-39)
Time frame: 6 months
EuroQol (EQ-5D)
Time frame: 6 months
Geriatric Depression Scale Short Form (GDS-15)
Time frame: 6 months
Modified Group Health Association of America's Consumer Satisfaction Survey (GHAA)
Time frame: 6 months
Qualitative assessment, including a telemedicine focus group and 1:1 interviews with study participants
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2009.
- Background: PubMed 8341308Hubble JP, Pahwa R, Michalek DK, Thomas C, Koller WC. Interactive video conferencing: a means of providing interim care to Parkinson's disease patients. Mov Disord. 1993 Jul;8(3):380-2. doi: 10.1002/mds.870080326.
- Background: PubMed 17260340Cheng EM, Swarztrauber K, Siderowf AD, Eisa MS, Lee M, Vassar S, Jacob E, Vickrey BG. Association of specialist involvement and quality of care for Parkinson's disease. Mov Disord. 2007 Mar 15;22(4):515-22. doi: 10.1002/mds.21311.
- Background: PubMed 15867035McConnochie KM, Wood NE, Kitzman HJ, Herendeen NE, Roy J, Roghmann KJ. Telemedicine reduces absence resulting from illness in urban child care: evaluation of an innovation. Pediatrics. 2005 May;115(5):1273-82. doi: 10.1542/peds.2004-0335.
- Background: PubMed 16438773Samii A, Ryan-Dykes P, Tsukuda RA, Zink C, Franks R, Nichol WP. Telemedicine for delivery of health care in Parkinson's disease. J Telemed Telecare. 2006;12(1):16-8. doi: 10.1258/135763306775321371.
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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.
E. Ray Dorsey, MD, MBA principal investigator
University of Rochester
Kevin Biglan, MD, MPH principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease, run by University of Rochester at 1 site in United States.
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 5 inclusion and 1 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 13 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The feasibility of telemedicine, based on participant ability to complete 75% or more of the trial visits. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00668551, which also lists 4 linked publications.
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 13 Apr 2009.