An interventional study of Remote patient monitoring and Telephone in Diabetes Mellitus Self Management Education, Hypertension Self-management and Self Management, sponsored by Virginia Commonwealth University. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-26.
Sponsored by Virginia Commonwealth University · Not applicable, Interventional, and Other
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.
Virginia Commonwealth University is the lead sponsor of 641 studies on the registry; 82 are open to participants now.
Of its 88 completed or terminated interventional studies of FDA-regulated products, 62 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
This usual care group will engage with Mobile Health and Wellness Program through standard telephone visits.
Behavioral: Telephone
This experimental remote group will engage with Mobile Health and Wellness program using remote patient monitoring devices.
Behavioral: Remote patient monitoring
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.
The usual interprofessional program activities are delivered via telephone visits without any at-home monitoring devices.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 8 weeks and through the end of participation at 16 weeks
Change in blood pressure
Change in blood pressure (SBP/DBP) over the course of the 16 weeks, particularly for baseline to post-study in the remote group. Blood pressure is measured in units of millimeters of mercury (mmHg). The readings are always given in pairs, with the upper (systolic) value first, followed by the lower (diastolic) value.
Time frame: Baseline, 8 weeks and through the end of participation at 16 weeks
Change in weight
Change in weight over the course of the 16 weeks, particularly for baseline to post study in the remote group.
Time frame: Baseline, 8 weeks and through the end of participation at 16 weeks
Change in blood oxygenation
Measured by a pulse oximeter over the course of the 16 weeks, particularly for baseline to post-study in the remote group. (No range outcome necessary- continuous value)
Time frame: Baseline, 8 weeks and through the end of participation at 16 weeks
Change in blood glucose
Change in blood glucose over the course of the 16 weeks, particularly for baseline to post study in the remote group.
Time frame: Baseline, 8 weeks and through the end of participation at 16 weeks
Plan to share: No
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Virginia Commonwealth University