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Study closed due to not able to find any real stroke patients interested to participate.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MedRem application | Experimental | MedRem smartwatch application |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MedRem application | Device | Medication adherence smartwatch application |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 30 days |
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Inclusion Criteria:
Phase 1 (Controls)
Phase 2 (Stroke Patients)
Exclusion Criteria:
Phase 1 (Controls)
Phase 2 (Stroke Patients)
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| Name | Affiliation | Role |
|---|---|---|
| John Stankovic | University of Virginia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Virginia | Charlottesville | Virginia | 22903 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | MedRem Application | MedRem smartwatch application MedRem application: Medication adherence smartwatch application |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | MedRem Application | MedRem smartwatch application MedRem application: Medication adherence smartwatch application |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | No data were collected for this Outcome Measure | Posted | 30 days |
|
|
End of Week 1
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MedRem Application | MedRem smartwatch application MedRem application: Medication adherence smartwatch application |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John Stankovic | University of Virginia | 434-982-2275 | jas9f@virginia.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 9, 2019 | Dec 11, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D055118 | Medication Adherence |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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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.
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Primary | 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. | No data were collected for this Outcome Measure | Posted | 30 days |
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| 0 |
| 5 |
| 0 |
| 5 |
| 0 |
| 5 |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |