Adherence to Medical Treatments for Telemedicine Patients

NCT04180475 | Terminated Results DMC FDA Device

• 1 other identifier: 21012
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Medication Adherence

Keywords

Remote monitoring

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

MedRem application

EXPERIMENTAL

MedRem smartwatch application

Device: MedRem application

Interventions

MedRem application DEVICE

Medication adherence smartwatch application

MedRem application

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Phase 1 (Controls)
• 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)
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22903, United States

Location

MeSH Terms

Conditions

Stroke; Medication Adherence

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Results Point of Contact

• Title: John Stankovic
• Organization: University of Virginia

jas9f@virginia.edu

434-982-2275

Study Officials

• John Stankovic

  University of Virginia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Comp Science

Model Details: 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.

Study Record Dates

• First Submitted: October 30, 2019
• First Posted: November 27, 2019
• Study Start: May 30, 2019
• Primary Completion: January 25, 2023
• Study Completion: January 25, 2023
• Last Updated: March 19, 2024
• Results First Posted: March 19, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)