Quality of Life Clinical Trial
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).
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. |
Country | Name | City | State |
---|---|---|---|
United States | University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
University of Pittsburgh | National Heart, Lung, and Blood Institute (NHLBI) |
United States,
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 |
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