StrokeNCT04180475
Adherence to Medical Treatments for Telemedicine Patients
A study testing MedRem application in people with Stroke and Medication Adherence, run by University of Virginia at 1 site in United States.
Trial summary
This study will test the feasibility of MedRem, a novel medication reminder and tracking system on wearable wrist devices, specifically with the Apple Watch 4. The study team will load the MedRem app onto two Apple Watch 4s for use during the study. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke, Medication Adherence
- What is being tested?
- MedRem application
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 30 May 2019to 25 Jan 2023
- Phase
- Interventional
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Phase 1 (Controls)
- 18 - 75 years old
- Good general health (self-reported), with no history of cerebral vascular accident (CVA)
- English-speaking
- Willingness and ability to comply with scheduled visits and study procedures
- Phase 2 (Stroke Patients)
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- 18 - 75 years old
- English-speaking
- Willingness and ability to comply with scheduled visits and study procedures
- Have requirements for home- based therapy regimens (i.e. physical/occupational therapy)
- Require medications for secondary stroke prevention (e.g. antithrombotic therapy to prevent ischemic stroke, stroke risk factor management with blood pressure, diabetes, cholesterol medications).
- Have a Modified Rankin Scale for Neurologic Disability (MDS) of 2 - 4
Who cannot join
- Phase 1 (Controls)
- Pregnant women, fetuses, neonates, children, prisoners, cognitively impaired, non-English speaking subjects
- Prohibitive cognitive impairments or language deficits
- Does not have wireless internet connection at home
- Phase 2 (Stroke Patients)
- Pregnant women, fetuses, neonates, children, prisoners, cognitively impaired, non-English speaking subjects
Show all 11Show fewer
- Have a Modified Rankin Scale for Neurologic Disability (MDS) of 0-1 or 5
- Prohibitive cognitive impairments or language deficits
- Significant weakness, dystonia, or spasticity that will prevent proper use and response to the Apple Watch device
- Live in nursing home or rehabilitation facility
- Does not have wireless internet connection at home
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia
Charlottesville, Virginia, 22903
About this study
This study will test the feasibility of MedRem, a novel medication reminder and tracking system on wearable wrist devices, specifically with the Apple Watch 4. The study team will load the MedRem app onto two Apple Watch 4s for use during the study. As the device is placed on the wrist, it is free from the limitations of smartphones. However, one of the major challenges in developing interactive systems for wrist devices is their form factor. The touch screens available on these devices are tiny and much smaller compared to smart phones and tablet computers. MedRem enables user interactions by incorporating speech recognition and text-to-speech features along with clever interface design. The tiny display of the device is used for minimal inputs and outputs, while a user can retrieve and provide more information from/to the system through voice commands. Personalized models are built and updated over time to reduce errors in recognizing users' voice commands, and thus better user experience is provided.
- Conditions
- Stroke, Medication Adherence
- Being tested
- MedRem application
- Keywords
- Remote monitoring
- Medical subject headings
- Stroke, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MedRem applicationDevice
Medication adherence smartwatch application
| Study group | Role | What they receive |
|---|---|---|
| MedRem application | Experimental | MedRem smartwatch application Receives: Device: MedRem application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Use of MedRem System
Assess the patients' adherence to medications and exercise. Adherence will be measured by patient responses to questions prompted by the MedRem System.
Measured: 30 days
Assessment of Survey
Acceptance and usability will be measured by the Intervention Patient MedRem Usability Survey. Steps were taken and distance covered data will also be collected from the Apple Watch.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2019
- Study start30 May 2019
- Primary completion25 Jan 2023
- Study completion25 Jan 2023
Why it stopped: Study closed due to not able to find any real stroke patients interested to participate.
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 StrokeStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- Phase 1 - determine the feasibility of the Apple Watch medication/exercise reminder system MedRem by deploying the system to control subjects. Phase 2 of study- assess the subjects' adherence to medications, exercise and checking heart rate (and quality of the exercise), with the use of MedRem • assess the acceptance and usability of the MedRem system.
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John A Stankovic, University of Virginia
- Investigators
- John Stankovic, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04180475
- Sponsor's protocol ID
- 21012
- Status last verified
- Feb 2024
- First submitted
- 30 Oct 2019
- Last updated
- 19 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adherence to Medical Treatments for Telemedicine Patients
- ClinicalTrials.gov ID
- NCT04180475
- Acronym / sponsor ID
- 21012
- Conditions
- Stroke, Medication Adherence
- Keywords
- Remote monitoring
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study closed due to not able to find any real stroke patients interested to participate.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- 30 May 2019 (actual)
- Primary completion
- 25 Jan 2023 (actual)
- Study completion
- 25 Jan 2023 (actual)
- First posted
- 27 Nov 2019 (actual)
- Results
- Posted 19 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will test the feasibility of MedRem, a novel medication reminder and tracking system on wearable wrist devices, specifically with the Apple Watch 4. The study team will load the MedRem app onto two Apple Watch 4s for use during the study. As the device is placed on the wrist, it is free from the limitations of smartphones. However, one of the major challenges in developing interactive systems for wrist devices is their form factor. The touch screens available on these devices are tiny and much smaller compared to smart phones and tablet computers. MedRem enables user interactions by incorporating speech recognition and text-to-speech features along with clever interface design. The tiny display of the device is used for minimal inputs and outputs, while a user can retrieve and provide more information from/to the system through voice commands. Personalized models are built and updated over time to reduce errors in recognizing users' voice commands, and thus better user experience is provided.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Phase 1 - determine the feasibility of the Apple Watch medication/exercise reminder system MedRem by deploying the system to control subjects. Phase 2 of study- assess the subjects' adherence to medications, exercise and checking heart rate (and quality of the exercise), with the use of MedRem • assess the acceptance and usability of the MedRem system.
| Arm | Type | Receives |
|---|---|---|
| MedRem application | Experimental | Device: MedRem applicationMedRem smartwatch application |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Phase 1 (Controls)
- Phase 2 (Stroke Patients)
- 18 - 75 years old
- English-speaking
- Willingness and ability to comply with scheduled visits and study procedures
Key exclusion criteria (11 listed)
- Phase 1 (Controls)
- Phase 2 (Stroke Patients)
- Pregnant women, fetuses, neonates, children, prisoners, cognitively impaired, non-English speaking subjects
- Have a Modified Rankin Scale for Neurologic Disability (MDS) of 0-1 or 5
- Prohibitive cognitive impairments or language deficits
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 |
|---|---|---|
| MedRem applicationMedication adherence smartwatch application | Device | MedRem application |
Primary outcome
Use of MedRem System
Time frame: 30 days
Assess the patients' adherence to medications and exercise. Adherence will be measured by patient responses to questions prompted by the MedRem System.
Assessment of Survey
Time frame: 30 days
Acceptance and usability will be measured by the Intervention Patient MedRem Usability Survey. Steps were taken and distance covered data will also be collected from the Apple Watch.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
John Stankovic principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MedRem application in people with Stroke and Medication Adherence, run by University of Virginia 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 12 inclusion and 11 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: stopped early, as of the sponsor's last update on 19 Mar 2024. 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?
Yes. Results are posted in the registry (first posted 19 Mar 2024). 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?
Use of MedRem System (time frame: 30 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 19 Mar 2024.