Health TrialsbyHealthPanel

Mobile Health Program for Rural Hypertension

ConditionsHypertension,EssentialAdherence, MedicationQuality of Life
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Pittsburgh

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Coaching application

    Behavioral

    A digital application for providing education and support for home-based blood pressure monitoring.

  • WebMD

    Other intervention

    Smartphone-based application for health education and/or monitoring.

  • Home-based blood pressure monitoring

    Behavioral

    Device for measuring blood pressure at home with blue tooth connectivity for automated collection.

Treatment groups

334 Participants
are divided into 2 treatment groups
Group A: InterventionExperimental treatment 2 interventions
Group B: Enhanced usual careActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline, 6 months

Secondary outcomes

1

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.

Time frame
Baseline, 6 months
2

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.

Time frame
Baseline, 12 months
3

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.

Time frame
Baseline, 6 months
4

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.

Time frame
Baseline, 12 months

Other outcomes

1

Change in systolic and diastolic blood pressure from baseline to 6 months, stratified by home-supervised blood pressure at baseline visit.

Change in home-based systolic and diastolic blood pressure from baseline to 6 months between the intervention and usual care arms, stratified by home-supervised blood pressure at baseline visit (systolic BP \<130 or \>=130 mm Hg; diastolic BP \<85 or \>=85 mm Hg in separate analyses).

Time frame
Baseline, 6 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Pittsburgh

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Source ClinicalTrials.gov
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