Clinical trial NCT04180475: Adherence to Medical Treatments for Telemedicine Patients
Official title: Adherence to Medical Treatments for Telemedicine Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Stroke
Medication Adherence
Keywords: Remote monitoring
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2019-11-27
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SEQUENTIAL
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.
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Use of MedRem System
timeFrame: 30 days
measure: Assessment of Survey
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
affiliation: University of Virginia
name: John Stankovic
role: PRINCIPAL_INVESTIGATOR
References: