Adherence to Medical Treatments for Telemedicine Patients

Study Overview
=================
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.

Official Title
-----------------
Adherence to Medical Treatments for Telemedicine Patients

Conditions
-----------------
Stroke, Medication Adherence

Intervention / Treatment
-----------------
* Device: MedRem application


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Phase 1 (Controls) 18 - 75 years old Good general health (self-reported), with no history of 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Intervention Model: Sequential Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MedRem application<br>MedRem smartwatch application | Device: MedRem application<br>* Medication adherence smartwatch application<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Remote monitoring