Diabetes Mellitus Self Management EducationNCT07075978
The Mobile Health and Wellness Program Remote Health Study
A study testing Remote patient monitoring and Telephone in people with Diabetes Mellitus Self Management Education and Hypertension Self-management, run by Virginia Commonwealth University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus Self Management Education, Hypertension Self-management, Self Management
- What is being tested?
- Remote patient monitoring and Telephone
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jul 2025to 10 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Prior diagnosis of Dementia; Alzheimer's disease, Lewy body, Parkinson's, or vascular dementia.
- No access to an internet connection.
Trial locations and contacts
1 site in 1 country.
United States1 site
School of Nursing Mobile Health and Wellness Program
Richmond, Virginia, 23298
About this study
Official title: MHWP Remote Health and Wellness Study
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
- Diabetes Mellitus Self Management Education, Hypertension Self-management, Self Management
- Being tested
- Remote patient monitoring, Telephone
- Keywords
- Older adults, Remote patient monitoring, Telehealth, Interprofessional
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote patient monitoringBehavioural
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.
TelephoneBehavioural
The usual interprofessional program activities are delivered via telephone visits without any at-home monitoring devices.
| Study group | Role | What they receive |
|---|---|---|
| Telehealth | Active comparator | This usual care group will engage with Mobile Health and Wellness Program through standard telephone visits. Receives: Behavioral: Telephone |
| Remote group | Experimental | This experimental remote group will engage with Mobile Health and Wellness program using remote patient monitoring devices. Receives: Behavioral: Remote patient monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 8 weeks and through the end of participation at 16 weeks
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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)
Measured: 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.
Measured: Baseline, 8 weeks and through the end of participation at 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2025
- Study start17 Jul 2025
- Primary completion1 Sep 2026
- Study completion10 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus Self Management EducationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lana Sargent, Virginia Commonwealth University
- Investigators
- Lana Sargent, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07075978
- Sponsor's protocol ID
- HM20031925-VCU
- Other IDs
- 1
- Status last verified
- Oct 2026
- First submitted
- 10 Jul 2025
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MHWP Remote Health and Wellness Study
- ClinicalTrials.gov ID
- NCT07075978
- Acronym / sponsor ID
- HM20031925-VCU
- Conditions
- Diabetes Mellitus Self Management Education, Hypertension Self-management, Self Management
- Keywords
- Older adults, Remote patient monitoring, Telehealth, Interprofessional
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- 17 Jul 2025 (actual)
- Primary completion
- 1 Sep 2026 (actual)
- Study completion
- 10 Sep 2026 (actual)
- First posted
- 20 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telehealth | Active comparator | Behavioral: TelephoneThis usual care group will engage with Mobile Health and Wellness Program through standard telephone visits. |
| Remote group | Experimental | Behavioral: Remote patient monitoringThis experimental remote group will engage with Mobile Health and Wellness program using remote patient monitoring devices. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- Prior diagnosis of Dementia; Alzheimer's disease, Lewy body, Parkinson's, or vascular dementia.
- No access to an internet connection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remote patient monitoringThe 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. | Behavioural | Remote group |
| TelephoneThe usual interprofessional program activities are delivered via telephone visits without any at-home monitoring devices. | Behavioural | Telehealth |
Primary outcome
PROMIS Self-Efficacy for Managing Chronic Conditions
Time frame: Baseline, 8 weeks and through the end of participation at 16 weeks
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.
The Medical Outcomes Study (MOS) Measures of Patient Adherence
Time frame: Baseline, 8 weeks and through the end of participation at 16 weeks
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.
The REALM Health Literacy
Time frame: Baseline, 8 weeks and through the end of participation at 16 weeks
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.
Change in mobile device proficiency at 16 weeks
Time frame: Baseline, 8 weeks and through the end of participation 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.
4 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lana Sargent principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote patient monitoring and Telephone in people with Diabetes Mellitus Self Management Education and Hypertension Self-management, run by Virginia Commonwealth University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PROMIS Self-Efficacy for Managing Chronic Conditions (time frame: Baseline, 8 weeks and through the end of participation at 16 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.