Mobile Health Program for Rural Hypertension

Quality of Life Clinical Trial

Official title:

Multilevel Mobile Health Program to Improve Rural Hypertension

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05546931
• Other study ID #: STUDY21120151
• Secondary ID: R01HL160749
• Status: Recruiting
• Phase: N/A
• Start date: September 4, 2023
• Est. completion date: June 2027

Study information

• Verified date: May 2024
• Source: University of Pittsburgh
• Contact: Jared W Magnani, MD
• Phone: 4123830611
• Email: magnanij[@]pitt.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 334
• Est. completion date: June 2027
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. 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

2. Residence in one of 48 counties categorized as rural by the Center for Rural Pennsylvania;

3. English-speaking at level appropriate for informed consent and study participation;

4. No plans to relocate from the area within 12 months of enrollment.

Exclusion Criteria:

1. Heart failure necessitating hospital admission =3 months prior to study inclusion;

2. 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;

3. Planned major surgery, cardiovascular or non-cardiovascular;

4. Pregnancy or planned pregnancy within 12 months;

5. Presence of non-cardiovascular conditions likely to be fatal within 12 months (e.g., cancer);

6. Inability to comprehend the study protocol, defined by failing 3 times to answer correctly a set of questions during consent;

7. Institutionalized status (e.g., nursing home, incarceration);

8. Inability to operate a smartphone or HBPM device due to sensory or neurocognitive deficit.

Related Conditions & MeSH terms

• Adherence, Medication
• Essential Hypertension
• Hypertension
• Hypertension,Essential
• Quality of Life

Intervention

Behavioral:
• Coaching application
A digital application for providing education and support for home-based blood pressure monitoring.

Other:
• WebMD
Smartphone-based application for health education and/or monitoring.

Behavioral:
• Home-based blood pressure monitoring
Device for measuring blood pressure at home with blue tooth connectivity for automated collection.

Locations

Country	Name	City	State
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, 6 months
Secondary	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.	Baseline, 6 months
Secondary	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.	Baseline, 12 months
Secondary	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.	Baseline, 6 months
Secondary	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.	Baseline, 12 months
Secondary	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.	Baseline, 6 months
Secondary	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.	Baseline, 12 months