The Mobile Health and Wellness Program Remote Health Study

Not Applicable

Not yet recruiting

• Conditions: Diabetes Mellitus Self Management Education; Hypertension Self-management; Self Management

• Registration Number: NCT07075978
• Lead Sponsor: Virginia Commonwealth University

Brief Summary

This clinical trial trial design will be a pretest-posttest comparison group pilot study that evaluates the implementation of team-based telemedicine visits and remote patient monitoring.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-06
• Study Start: 2025-07-01
• Study First Submitted: 2025-07-10
• Study First Submitted QC: 2025-07-10
• Last Update Submitted: 2025-07-10
• Study First Posted: 2025-07-20
• Last Update Posted: 2025-07-20
• Primary Completion: 2026-04
• Study Completion: 2026-04-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Participant in the Mobile Health and Wellness Program
• 18 years old or over
• Reporting with hypertension, diabetes, congestive heart failure, or chronic obstructive pulmonary disease
• English-speaking
• Currently taking blood pressure and/or diabetes medications
• Capable of engaging with the Health Recovery Solutions (HRS) Remote Patient Monitoring (RPM) device or participating in standard telephone-based care.

Exclusion Criteria

• Prior diagnosis of Dementia; Alzheimer's disease, Lewy body, Parkinson's, or vascular dementia.
• No access to an internet connection.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in self-efficacy in managing chronic conditions at 16 weeks	From baseline to the end of participation at 16 weeks	The tool will be the PROMIS Self-Efficacy for Managing Chronic Conditions - Managing Medications and Treatment 8a.
Improved adherence to medical recommendations at 16 weeks	From baseline to post-study at 16 weeks	The tool will be The Medical Outcomes Study (MOS) Measures of Patient Adherence is a 5-item scale to assess the adherence of patients with chronic conditions to medical recommendations.
Change in health literacy at 16 weeks	From baseline to the end of participation at 16 weeks	The REALM Health Literacy - Short Form is a 7-item assessment tool that is a validated rapid measure of health literacy.
Change in mobile device proficiency at 16 weeks	From baseline to the end of participation at 16 weeks	The Mobile Device Proficiency (MDPQ-16) is a 16-item survey measuring participant's ability to operate a mobile device.

Secondary Outcome Measures

Name	Time	Method
Change in blood pressure	Enrollment to 16 weeks	Change in blood pressure (SBP/DBP) over the course of the 16 weeks, particularly for baseline to post study in the remote group.
Change in weight	Enrollment to 16 weeks	Change in weight over the course of the 16 weeks, particularly for baseline to post study in the remote group.
Change in blood oxygenation	Enrollment to 16 weeks	Change in pulse ox over the course of the 16 weeks, particularly for baseline to post study in the remote group.
Change in blood glucose	Enrollment to 16 weeks	Change in blood glucose over the course of the 16 weeks, particularly for baseline to post study in the remote group.

Trial Locations

Locations (1)

School of Nursing Mobile Health and Wellness Program; 🇺🇸 Richmond, Virginia, United States