Enrolling by invitation NCT07075978
The Mobile Health and Wellness Program Remote Health Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Remote patient monitoring, Telephone.
- Who it may be relevant to
- Registry conditions: Diabetes Mellitus Self Management Education, Hypertension Self-management, Self Management. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
MHWP Remote Health and Wellness Study
Overview
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.
Interventions
- 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. - Behavioral Telephone
The usual interprofessional program activities are delivered via telephone visits without any at-home monitoring devices.
Primary outcome measures
- PROMIS Self-Efficacy for Managing Chronic Conditions [Time frame: Baseline, 8 weeks and through the end of participation at 16 weeks]
- The Medical Outcomes Study (MOS) Measures of Patient Adherence [Time frame: Baseline, 8 weeks and through the end of participation at 16 weeks]
- The REALM Health Literacy [Time frame: Baseline, 8 weeks and through the end of participation at 16 weeks]
- Change in mobile device proficiency at 16 weeks [Time frame: Baseline, 8 weeks and through the end of participation at 16 weeks]
Secondary outcome measures (4)
- Change in blood pressure [Time frame: Baseline, 8 weeks and through the end of participation at 16 weeks]
- Change in weight [Time frame: Baseline, 8 weeks and through the end of participation at 16 weeks]
- Change in blood oxygenation [Time frame: Baseline, 8 weeks and through the end of participation at 16 weeks]
- Change in blood glucose [Time frame: Baseline, 8 weeks and through the end of participation at 16 weeks]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 1 center
- School of Nursing Mobile Health and Wellness Program — Richmond
Identifiers
NCT: NCT07075978 · HM20031925-VCU · 1