Medication Adherence, Stroke
Conditions
Keywords
Remote monitoring
Brief 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. 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.
Interventions
DEVICEMedRem application
Medication adherence smartwatch application
Sponsors
University of Virginia
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
OTHER
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* 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) * 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
Exclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Use of MedRem System | 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 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| MedRem Application MedRem smartwatch application
MedRem application: Medication adherence smartwatch application | 5 |
| Total | 5 |
Baseline characteristics
| Characteristic | MedRem Application | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 5 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 2 Participants | — |
| Sex: Female, Male Male | 3 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 5 |
| other Total, other adverse events | 0 / 5 |
| serious Total, serious adverse events | 0 / 5 |
Outcome results
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.
Time frame: 30 days
Population: No data were collected for this Outcome Measure
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.
Time frame: 30 days
Population: No data were collected for this Outcome Measure