Hypertension,EssentialNCT05546931
Mobile Health Program for Rural Hypertension
A study testing Coaching application, WebMD and Home-based blood pressure monitoring in people with Hypertension,Essential and Adherence, Medication, run by University of Pittsburgh at 1 site in United States.
Trial summary
Hypertension (HTN) is the leading modifiable cause of cardiovascular disease. Rural individuals experience challenges of the rural health divide: geographic distance from providers, social isolation, limited social resources, and high rates of low health literacy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension,Essential, Adherence, Medication, Quality of Life
- What is being tested?
- Coaching application, WebMD and Home-based blood pressure monitoring
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 334 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Sep 2023to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- History of uncontrolled hypertension, identified from the electronic health record problem list and an average systolic BP 140-199 or diastolic BP 90-119 mm Hg at 2 ambulatory visits, one of which is within 6 months of study entry
- Residence in one of 48 counties categorized as rural by the Center for Rural Pennsylvania;
- English-speaking at level appropriate for informed consent and study participation;
- No plans to relocate from the area within 12 months of enrollment.
Who cannot join
- Heart failure necessitating hospital admission ≤3 months prior to study inclusion;
- Acute coronary syndrome (defined as at least 2 of the following: chest pain, ischemic electrocardiographic changes, or troponin ≥0.1 ng/mL) ≤3 months prior to study inclusion;
- Planned major surgery, cardiovascular or non-cardiovascular;
- Pregnancy or planned pregnancy within 12 months;
- Presence of non-cardiovascular conditions likely to be fatal within 12 months (e.g., cancer);
- Inability to comprehend the study protocol, defined by failing 3 times to answer correctly a set of questions during consent;
- Institutionalized status (e.g., nursing home, incarceration);
- Inability to operate a smartphone or HBPM device due to sensory or neurocognitive deficit.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Jared W Magnani, MD, 412 383 0611, magnanij@pitt.edu
About this study
Official title: Multilevel Mobile Health Program to Improve Rural Hypertension
Hypertension (HTN) is the leading modifiable cause of cardiovascular disease. Rural individuals experience challenges of the rural health divide: geographic distance from providers, social isolation, limited social resources, and high rates of low health literacy. This study evaluates a home-based blood pressure monitoring (HBPM) program that provides longitudinal health education, empathic guidance, monitoring, and adaptable patient-centered coaching to rural individuals. Participants in this study will be randomized to receive (1) HBPM with the intervention; or (2) the control, consisting of HBPM and a smartphone with a general health application (WebMD).
Read the detailed description
Hypertension (HTN) has increasing prevalence, is the leading cause of cardiovascular morbidity and mortality, and contributes significantly to health care utilization and costs. Social determinants of health (SDOH) exacerbate patients' access to therapies, adherence, and health outcomes. A robust literature demonstrates the effects of income, education, health literacy, and social resources on access to HTN treatment; medication adherence; and short- and long-term likelihood of clinical adversity. In the U.S., geographic obstacles to care further complicate HTN treatment and outcomes for rural individuals. This single-center, parallel group randomized clinical trial (RCT) evaluates a home-based blood pressure monitoring (HBPM) and cardiovascular mobile health platform in rural individuals with hypertension (HTN). The intervention uses a virtual coaching platform to provide health education, monitoring, guidance, and adaptable patient-centered coaching to rural individuals. The 6-month intervention provides a personalized curriculum to promote HBPM; medication adherence; HTN education; non-pharmacologic strategies for HTN management; preparation for the clinical encounter; and enhanced problem-solving and engagement for rural individuals. The trial is 12-month duration with visits at baseline, 6, and 12 months. Individuals with poorly controlled HTN (systolic BP 140-199 or diastolic BP 90-119 mm Hg at 2 ambulatory visits) will be randomized to: (1) intervention, the HBPM coaching intervention and HBPM; or (2) control, smartphone with a general health application (WebMD) and HBPM. For both intervention and control, summaries of BP measures are provided to clinicians in order to improve HTN management for rural patients. The primary study outcome is improvement in BP from baseline to 6 months. The secondary study outcomes are comparison of adherence to antihypertensive medications and patient-reported outcomes in the intervention and usual care arms at 6 and 12 months.
- Being tested
- Coaching application, WebMD, Home-based blood pressure monitoring
- Keywords
- hypertension, adherence, rurality
- Medical subject headings
- Essential Hypertension, Medication Adherence, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coaching applicationBehavioural
A digital application for providing education and support for home-based blood pressure monitoring.
WebMDOther
Smartphone-based application for health education and/or monitoring.
Home-based blood pressure monitoringBehavioural
Device for measuring blood pressure at home with blue tooth connectivity for automated collection.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | A smartphone-based, interactive coaching application designed to enhance adherence to home-based blood pressure monitoring, provided guidance on blood pressure management, patient-facing education, and assistance with modifying behaviors associated with poor blood pressure control; connected to a wireless blood pressure cuff for accurate blood pressure measurement and automated storage on a digital platform. All participants in the experimental arm receive a smartphone for the 6-month intervention duration and the home-based blood pressure cuff. Receives: Behavioral: Coaching application; Behavioral: Home-based blood pressure monitoring |
| Enhanced usual care | Active comparator | WebMD, a smartphone-based tool for learning about blood pressure and other health conditions. Enhanced usual care participants receive a wireless blood pressure cuff for accurate blood pressure measurement and automated storage on a digital platform. All participants in the experimental arm receive a smartphone for the 6-month intervention duration and the home-based blood pressure cuff. Receives: Other: WebMD; Behavioral: Home-based blood pressure monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in systolic and diastolic blood pressure from baseline to 6 months
Change in home-based systolic and diastolic blood pressure from baseline to 6 months between the intervention and usual care arms.
Measured: Baseline, 6 months
Secondary outcomes (7)
Adherence to antihypertensive medications
Adherence to antihypertensive medication from baseline to 6 months between the intervention and usual care arms using Proportion of Days Covered, ranging from 0 to 100%, where higher values indicate superior medication adherence.
Measured: Baseline, 6 months
Adherence to antihypertensive medications
Adherence to antihypertensive medication from baseline to 12 months between the intervention and usual care arms using Proportion of Days Covered, ranging from 0 to 100%, where higher values indicate superior medication adherence.
Measured: Baseline, 12 months
Patient-Reported Outcomes
Patient-reported outcomes between the intervention and usual care arms at 6 months measured with the NIH Patient-Reported Outcomes Measurement Information System (PROMIS) with distinct assessments of the following: (1) physical function, (2) anxiety, (3) depression, (4) fatigue, (5) sleep, (6) ability to participate in social roles, (7) social role satisfaction, and (8) interference in functioning by pain. Each domain is scored separately, such that scores for each domain range from 4 (lowest score) to 20 (highest score), where higher scores indicate greater impairment.
Measured: Baseline, 6 months
Patient-Reported Outcomes
Patient-reported outcomes between the intervention and usual care arms at 12 months measured with the NIH Patient-Reported Outcomes Measurement Information System (PROMIS) with distinct assessments of the following: (1) physical function, (2) anxiety, (3) depression, (4) fatigue, (5) sleep, (6) ability to participate in social roles, (7) social role satisfaction, and (8) interference in functioning by pain. Each domain is scored separately, such that scores for each domain range from 4 (lowest score) to 20 (highest score), where higher scores indicate greater impairment.
Measured: Baseline, 12 months
Self-efficacy for managing medications and treatment
Patient-reported outcomes between the intervention and usual care arms at 6 months measured with the Patient-Reported Outcomes Measurement Information System Self-efficacy for managing medications and treatment, a 10-item instrument, scored from 10 (minimum) to 40 (maximum), where higher scores indicate superior self-efficacy.
Measured: Baseline, 6 months
Self-efficacy or managing medications and treatment
Patient-reported outcomes between the intervention and usual care arms at 12 months measured with the Patient-Reported Outcomes Measurement Information System Self-efficacy for managing medications and treatment, a 10-item instrument, scored from 10 (minimum) to 40 (maximum), where higher scores indicate superior self-efficacy.
Measured: Baseline, 12 months
Adherence to home blood pressure monitoring
Quantification of home blood pressure monitoring during the 6-month intervention phase, characterized as both a continuous and categorical measure, compared by study arm.
Measured: From enrollment to the end of the intervention phase at 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2022
- Study start4 Sep 2023
- Primary completionDec 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hypertension,EssentialStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel-arm, randomized clinical trial
- Masking
- None (open label)
- Enrolment
- 334 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Jared W Magnani, MD, MSc, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05546931
- Sponsor's protocol ID
- STUDY21120151
- Other IDs
- R01HL160749
- Status last verified
- Nov 2025
- First submitted
- 15 Sep 2022
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study team will share all of the individual participant data collected during the trial, after deidentification.
Publications
Odo CC, Mrkva A, Shepherd E, Davis N, Kaleida B, Muldoon MF, Magnani JW. Effect of Health Literacy on use of a Virtual Coach to Promote Home Blood Pressure Monitoring. J Clin Hypertens (Greenwich). 2026 Jun;28(6):e70320. doi: 10.1111/jch.70320.
PubMed 42324623
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multilevel Mobile Health Program to Improve Rural Hypertension
- ClinicalTrials.gov ID
- NCT05546931
- Acronym / sponsor ID
- STUDY21120151
- Keywords
- hypertension, adherence, rurality
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 334 participants (estimated)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 4 Sep 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 21 Sep 2022 (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.
Hypertension (HTN) is the leading modifiable cause of cardiovascular disease. Rural individuals experience challenges of the rural health divide: geographic distance from providers, social isolation, limited social resources, and high rates of low health literacy. This study evaluates a home-based blood pressure monitoring (HBPM) program that provides longitudinal health education, empathic guidance, monitoring, and adaptable patient-centered coaching to rural individuals. Participants in this study will be randomized to receive (1) HBPM with the intervention; or (2) the control, consisting of HBPM and a smartphone with a general health application (WebMD).
Detailed description
Hypertension (HTN) has increasing prevalence, is the leading cause of cardiovascular morbidity and mortality, and contributes significantly to health care utilization and costs. Social determinants of health (SDOH) exacerbate patients' access to therapies, adherence, and health outcomes. A robust literature demonstrates the effects of income, education, health literacy, and social resources on access to HTN treatment; medication adherence; and short- and long-term likelihood of clinical adversity. In the U.S., geographic obstacles to care further complicate HTN treatment and outcomes for rural individuals. This single-center, parallel group randomized clinical trial (RCT) evaluates a home-based blood pressure monitoring (HBPM) and cardiovascular mobile health platform in rural individuals with hypertension (HTN). The intervention uses a virtual coaching platform to provide health education, monitoring, guidance, and adaptable patient-centered coaching to rural individuals. The 6-month intervention provides a personalized curriculum to promote HBPM; medication adherence; HTN education; non-pharmacologic strategies for HTN management; preparation for the clinical encounter; and enhanced problem-solving and engagement for rural individuals. The trial is 12-month duration with visits at baseline, 6, and 12 months. Individuals with poorly controlled HTN (systolic BP 140-199 or diastolic BP 90-119 mm Hg at 2 ambulatory visits) will be randomized to: (1) intervention, the HBPM coaching intervention and HBPM; or (2) control, smartphone with a general health application (WebMD) and HBPM. For both intervention and control, summaries of BP measures are provided to clinicians in order to improve HTN management for rural patients. The primary study outcome is improvement in BP from baseline to 6 months. The secondary study outcomes are comparison of adherence to antihypertensive medications and patient-reported outcomes in the intervention and usual care arms at 6 and 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel-arm, randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Coaching application, Behavioral: Home-based blood pressure monitoringA smartphone-based, interactive coaching application designed to enhance adherence to home-based blood pressure monitoring, provided guidance on blood pressure management, patient-facing education, and assistance with modifying behaviors associated with poor blood pressure control; connected to a wireless blood pressure cuff for accurate blood pressure measurement and automated storage on a digital platform. All participants in the experimental arm receive a smartphone for the 6-month intervention duration and the home-based blood pressure cuff. |
| Enhanced usual care | Active comparator | Other: WebMD, Behavioral: Home-based blood pressure monitoringWebMD, a smartphone-based tool for learning about blood pressure and other health conditions. Enhanced usual care participants receive a wireless blood pressure cuff for accurate blood pressure measurement and automated storage on a digital platform. All participants in the experimental arm receive a smartphone for the 6-month intervention duration and the home-based blood pressure cuff. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- History of uncontrolled hypertension, identified from the electronic health record problem list and an average systolic BP 140-199 or diastolic BP 90-119 mm Hg at 2 ambulatory visits, one of which is within 6 months of study entry
- Residence in one of 48 counties categorized as rural by the Center for Rural Pennsylvania;
- English-speaking at level appropriate for informed consent and study participation;
- No plans to relocate from the area within 12 months of enrollment.
Key exclusion criteria (8 listed)
- Heart failure necessitating hospital admission ≤3 months prior to study inclusion;
- Acute coronary syndrome (defined as at least 2 of the following: chest pain, ischemic electrocardiographic changes, or troponin ≥0.1 ng/mL) ≤3 months prior to study inclusion;
- Planned major surgery, cardiovascular or non-cardiovascular;
- Pregnancy or planned pregnancy within 12 months;
- Presence of non-cardiovascular conditions likely to be fatal within 12 months (e.g., cancer);
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 |
|---|---|---|
| Coaching applicationA digital application for providing education and support for home-based blood pressure monitoring. | Behavioural | Intervention |
| WebMDSmartphone-based application for health education and/or monitoring. | Other | Enhanced usual care |
| Home-based blood pressure monitoringDevice for measuring blood pressure at home with blue tooth connectivity for automated collection. | Behavioural | Enhanced usual care, Intervention |
Primary outcome
Change in systolic and diastolic blood pressure from baseline to 6 months
Time frame: Baseline, 6 months
Change in home-based systolic and diastolic blood pressure from baseline to 6 months between the intervention and usual care arms.
7 secondary outcomes
Adherence to antihypertensive medications
Time frame: Baseline, 6 months
Adherence to antihypertensive medications
Time frame: Baseline, 12 months
Patient-Reported Outcomes
Time frame: Baseline, 6 months
Patient-Reported Outcomes
Time frame: Baseline, 12 months
Self-efficacy for managing medications and treatment
Time frame: Baseline, 6 months
Self-efficacy or managing medications and treatment
Time frame: Baseline, 12 months
Adherence to home blood pressure monitoring
Time frame: From enrollment to the end of the intervention phase at 6 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- Derived from this study: PubMed 42324623Odo CC, Mrkva A, Shepherd E, Davis N, Kaleida B, Muldoon MF, Magnani JW. Effect of Health Literacy on use of a Virtual Coach to Promote Home Blood Pressure Monitoring. J Clin Hypertens (Greenwich). 2026 Jun;28(6):e70320. doi: 10.1111/jch.70320.
- Individual participant dataSharing planned: Yes. The study team will share all of the individual participant data collected during the trial, after deidentification.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coaching application, WebMD and Home-based blood pressure monitoring in people with Hypertension,Essential and Adherence, Medication, run by University of Pittsburgh 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 4 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 19 Nov 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jared W Magnani, MD (4123830611, magnanij@pitt.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in systolic and diastolic blood pressure from baseline to 6 months (time frame: Baseline, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05546931, which also lists 1 linked publication.
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 19 Nov 2025.