Adherence to Medical Treatments for Telemedicine Patients

Stroke Clinical Trial

Official title:

Adherence to Medical Treatments for Telemedicine Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04180475
• Other study ID #: 21012
• Status: Terminated
• Phase: N/A
• Start date: May 30, 2019
• Est. completion date: January 25, 2023

Study information

• Verified date: February 2024
• Source: University of Virginia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: January 25, 2023
• Est. primary completion date: January 25, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Medication Adherence
• Stroke

Intervention

Device:
• MedRem application
Medication adherence smartwatch application

Locations

Country	Name	City	State
United States	University of Virginia	Charlottesville	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
University of Virginia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	30 days
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.	30 days