The Mobile Health and Wellness Program Remote Health Study

NCT07075978 | Enrolling By Invitation

• 2 other identifiers: VCU HM200319251
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Self Management; Diabetes Mellitus Self Management Education; Hypertension Self-management

Keywords

Older adults; Remote patient monitoring; Telehealth; Interprofessional

Outcome Measures

Primary Outcomes (4)

• PROMIS Self-Efficacy for Managing Chronic Conditions

  Change in self-efficacy in managing chronic conditions at 16 weeks, the tool will be the PROMIS Self-Efficacy for Managing Chronic Conditions - The PROMIS Self-Efficacy scoring system is designed to assess the confidence of individuals in managing their health and daily activities. It is based on a T-score metric, where a score of 10 points corresponds to one standard deviation (SD) from the mean. The PROMIS scoring system has a mean of 50 and a standard deviation (SD) of 10 in the US General Population. A score of 40 is one SD lower than the mean, while a score of 60 is one SD higher. This scoring system is used to evaluate the self-efficacy for managing chronic conditions and daily activities, providing a standardized way to measure and compare the effectiveness of interventions and treatments.

  Baseline, 8 weeks and through the end of participation at 16 weeks

• The Medical Outcomes Study (MOS) Measures of Patient Adherence

  Improved adherence to medical recommendations 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. To score a Medical Outcomes Study (MOS) survey, you first need to recode the raw survey responses according to the specific scale's rules. Then, you average the recoded item scores to get a subscale score. For an overall index, you average the scores for all relevant items. Finally, you can transform these average scores to a 0-100 scale, where 100 represents the best possible score.

  Baseline, 8 weeks and through the end of participation at 16 weeks

• The REALM Health Literacy

  Change in health literacy at 16 weeks, The REALM Health Literacy - Short Form is a 7-item assessment tool that is a validated rapid measure of health literacy. It is a 7-item word recognition test to screen a patient's health literacy quickly. The patient is asked to read the words aloud. Scores are interpreted into a reading grade level equivalent, takes about one minute and requires minimal training.

  Baseline, 8 weeks and through the end of participation at 16 weeks

• Change in mobile device proficiency at 16 weeks

  The Mobile Device Proficiency (MDPQ-16) is a 16-item survey measuring participants' ability to operate a mobile device. First, assign a numerical value from 1 to 5 to each item, with one being "Never Tried" and five being "Very Easily". Next, calculate the average score for each of the eight subscales (Mobile Device Basics, Communication, Data and File Storage, Internet, Calendar, Entertainment, Privacy, and Troubleshooting/Software Management). Finally, add the eight subscale averages to obtain a total score ranging from 8 to 40.

  Baseline, 8 weeks and through the end of participation at 16 weeks

Secondary Outcomes (4)

• Change in blood pressure

  Baseline, 8 weeks and through the end of participation at 16 weeks

• Change in weight

  Baseline, 8 weeks and through the end of participation at 16 weeks

• Change in blood oxygenation

  Baseline, 8 weeks and through the end of participation at 16 weeks

• Change in blood glucose

  Baseline, 8 weeks and through the end of participation at 16 weeks

Study Arms (2)

Telehealth

ACTIVE COMPARATOR

This usual care group will engage with Mobile Health and Wellness Program through standard telephone visits.

Behavioral: Telephone

Remote group

EXPERIMENTAL

This experimental remote group will engage with Mobile Health and Wellness program using remote patient monitoring devices.

Behavioral: Remote patient monitoring

Interventions

Remote patient monitoring BEHAVIORAL

The usual interprofessional program activities are delivered via remote patient monitoring kits. The kit includes a tablet for virtual visits with the Mobile Health and Wellness Team and access to educational videos, as well as at-home monitoring devices for blood pressure, blood sugar if diabetic, pulse ox if COPD, and/or weight scale.

Remote group

Telephone BEHAVIORAL

The usual interprofessional program activities are delivered via telephone visits without any at-home monitoring devices.

Telehealth

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant in the Mobile Health and Wellness Program
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (1)

School of Nursing Mobile Health and Wellness Program

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Interventions

Remote Patient Monitoring

Intervention Hierarchy (Ancestors)

Telemedicine; Delivery of Health Care; Patient Care Management; Health Services Administration

Study Officials

• Lana Sargent

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Dean for Practice and Community Engagement

Study Record Dates

• First Submitted: July 10, 2025
• First Posted: July 20, 2025
• Study Start: July 17, 2025
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: December 9, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)