Adherence to Medical Treatments for Telemedicine Patients

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 Overview

• Status: Terminated
• Conditions: Stroke; Medication Adherence
• Intervention / Treatment: Device: MedRem application

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • University of Virginia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MedRem application; MedRem smartwatch application	Device: MedRem application; Medication adherence smartwatch application

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

Collaborators and Investigators

• Sponsor: University of Virginia
• Investigators: Principal Investigator: John Stankovic, University of Virginia

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2019
• Primary Completion (Actual): January 25, 2023
• Study Completion (Actual): January 25, 2023

Study Registration Dates

• First Submitted: October 30, 2019
• First Submitted That Met QC Criteria: November 26, 2019
• First Posted (Actual): November 27, 2019

Study Record Updates

• Last Update Posted (Actual): March 19, 2024
• Last Update Submitted That Met QC Criteria: February 19, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Remote monitoring
• Other Study ID Numbers: 21012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No