Medication AdherenceNCT03940534
Utilization of the TAD Device for Dispensing Pain Medications in Hospice Patients
A study testing TAD in people with Medication Adherence and Satisfaction, Personal, run by Intent Solutions, Inc. at 3 sites in United States.
Trial summary
A novel device, TAD, has been developed to aid adherence to prescribed regimens and may have a roll in hospice pain management. This study aims to assess medication adherence relating to missed doses or improperly timed doses with and without the aid of a mobile device as a primary endpoint. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Medication Adherence, Satisfaction, Personal
- What is being tested?
- TAD
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 3 sitesUnited States
- Study dates
- 9 Mar 2018to 26 Feb 2019
- Phase
- Interventional
- 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
Who may be able to join
- any patient taking morphine ER or Oxycontin on one of three hospice home teams
Who cannot join
- pregnancy
- inability to demonstrate competent use of the device
- age less than 18
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Haven: Advanced Illness Care
Gainesville, Florida, 32606
Haven: Advanced Illness Care
Lake City, Florida, 32055
Haven: Advanced Illness Care
Palatka, Florida, 32177
About this study
A novel device, TAD, has been developed to aid adherence to prescribed regimens and may have a roll in hospice pain management. This study aims to assess medication adherence relating to missed doses or improperly timed doses with and without the aid of a mobile device as a primary endpoint. Secondary endpoints will be patient, nursing, and provider satisfaction.
Read the detailed description
This study is a randomized crossover study in which patients will be randomized to start with or without a mobile device assisting the patient or caregiver in using the device. The investigators aim to enroll 20 patients across 3 sites. Each patient is expected to participate in the study for 12 weeks. After the first 2 weeks of participation, the patient will either begin using the mobile device to assist or will stop using the mobile device for the next 2 weeks. after the initial 4 weeks, the patient will choose to continue with or without using the mobile device.
- Conditions
- Medication Adherence, Satisfaction, Personal
- Being tested
- TAD
- Medical subject headings
- Medication Adherence, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TADDevice
TAD is a device used to aid medication adherence.
| Study group | Role | What they receive |
|---|---|---|
| Start with Mobile Device | Active comparator | Not described Receives: Device: TAD |
| Start without Mobile Device | Active comparator | Not described Receives: Device: TAD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference from Scheduled Dosing Time
The time difference between when the patient took the dose and the scheduled time of administration.
Measured: through study completion, up to 1 year
Missed Doses
The number of missed doses that occurred during the study.
Measured: through study completion, up to 1 year
Secondary outcomes (3)
Patient Satisfaction: scale of 1 to 5
The patient's satisfaction will be measured on a scale of 1 to 5 (from 1 being extremely dissatisfied to 5 being extremely satisfied). Satisfaction will be assessed with the follow questions:
- Using the mail order pharmacy to receive your pain medication?
- Ease of using the TAD device to dispense your pain medication?
- Ease of using the mobile device application with the TAD device? (ONLY when using the mobile application)
- The ability of the device to provide you the dose of pain medication at the correct time?
- The overall experience of using the TAD device?
Measured: through study completion, up to 1 year
Nurse Satisfaction: scale of 1 to 5
The nurse's satisfaction will be measured on a scale of 1 to 5 (from 1 being extremely dissatisfied to 5 being extremely satisfied). Satisfaction will be assessed with the follow questions:
- Using the mail order pharmacy get your patient their pain medication?
- Your patient's ability to use the TAD device to dispense their pain medication?
- Your patient's ability to use the mobile device application with the TAD device? (ONLY when using the mobile application)
- The ability of the device to increase compliance of the pain medication?
- The overall experience of using the TAD device?
Measured: through study completion, up to 1 year
Physician Satisfaction: scale of 1 to 5
The physician's satisfaction will be measured on a scale of 1 to 5 (from 1 being extremely dissatisfied to 5 being extremely satisfied). Satisfaction will be assessed with the follow questions:
- Using the mail order pharmacy get your patient their pain medication?
- Your patient's ability to use the TAD device to dispense their pain medication?
- Your patient's ability to use the mobile device application with the TAD device? (ONLY when using the mobile application)
- The ability of the device to increase compliance of the pain medication?
- The overall experience of using the TAD device?satisfaction will be measured on a scale of 1 to 5 for satisfaction of using the mail order pharmacy, ease of using the device, ease of using the mobile device, the ability of the device to accurately provide the dose, and overall experience with the device.
Measured: through study completion, up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2019
- Study start9 Mar 2018
- Primary completion26 Feb 2019
- Study completion26 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medication AdherenceStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This study is a randomized crossover design.
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intent Solutions, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christopher E Richter, PharmD, Principal investigator, Clinical PharmacistEllen Talos, MD, Study director, Medical Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03940534
- Sponsor's protocol ID
- 6195-001
- Status last verified
- May 2019
- First submitted
- 29 Apr 2019
- Last updated
- 8 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: Other study staff may apply to access the data through an appropriate IRB in the future, but this is not known at this time.
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilization of the TAD Device for Dispensing Pain Medications in Hospice Patients
- ClinicalTrials.gov ID
- NCT03940534
- Acronym / sponsor ID
- 6195-001
- Conditions
- Medication Adherence, Satisfaction, Personal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Intent Solutions, Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Mar 2018 (actual)
- Primary completion
- 26 Feb 2019 (actual)
- Study completion
- 26 Feb 2019 (actual)
- First posted
- 7 May 2019 (actual)
- 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.
A novel device, TAD, has been developed to aid adherence to prescribed regimens and may have a roll in hospice pain management. This study aims to assess medication adherence relating to missed doses or improperly timed doses with and without the aid of a mobile device as a primary endpoint. Secondary endpoints will be patient, nursing, and provider satisfaction.
Detailed description
This study is a randomized crossover study in which patients will be randomized to start with or without a mobile device assisting the patient or caregiver in using the device. The investigators aim to enroll 20 patients across 3 sites. Each patient is expected to participate in the study for 12 weeks. After the first 2 weeks of participation, the patient will either begin using the mobile device to assist or will stop using the mobile device for the next 2 weeks. after the initial 4 weeks, the patient will choose to continue with or without using the mobile device.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study is a randomized crossover design.
| Arm | Type | Receives |
|---|---|---|
| Start with Mobile Device | Active comparator | Device: TAD |
| Start without Mobile Device | Active comparator | Device: TAD |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- any patient taking morphine ER or Oxycontin on one of three hospice home teams
Key exclusion criteria (3 listed)
- pregnancy
- inability to demonstrate competent use of the device
- age less than 18
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TADTAD is a device used to aid medication adherence. | Device | Start with Mobile Device, Start without Mobile Device |
Primary outcome
Difference from Scheduled Dosing Time
Time frame: through study completion, up to 1 year
The time difference between when the patient took the dose and the scheduled time of administration.
Missed Doses
Time frame: through study completion, up to 1 year
The number of missed doses that occurred during the study.
3 secondary outcomes
Patient Satisfaction: scale of 1 to 5
Time frame: through study completion, up to 1 year
Nurse Satisfaction: scale of 1 to 5
Time frame: through study completion, up to 1 year
Physician Satisfaction: scale of 1 to 5
Time frame: through study completion, up to 1 year
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 8 May 2019.
- Individual participant dataSharing planned: Undecided. Other study staff may apply to access the data through an appropriate IRB in the future, but this is not known at this time.
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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.
Christopher E Richter, PharmD principal investigator
Clinical Pharmacist
Ellen Talos, MD study director
Medical Director
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TAD in people with Medication Adherence and Satisfaction, Personal, run by Intent Solutions, Inc. at 3 sites 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 1 inclusion and 3 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 8 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Difference from Scheduled Dosing Time (time frame: through study completion, up to 1 year). 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 8 May 2019.