No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
334 (estimated)
Sponsor
University of Pittsburgh · Other
Who this trial is looking for
This trial is looking for people living in rural areas who have high blood pressure that is not well controlled. Participants will use a home blood pressure monitor and receive support and education to help manage their condition.
Are You a Good Fit for This Trial?
You may be able to join if
I have high blood pressure that is not well controlled.
I live in a rural county in Pennsylvania.
I speak English well enough to participate in the study.
I plan to stay in the area for at least 12 months.
You may not be able to join if
I have been hospitalized for heart failure in the last 3 months.
I have had a heart attack in the last 3 months.
I have planned major surgery soon.
I am pregnant or plan to become pregnant in the next year.
I have a serious health condition that could be fatal in the next year.
I cannot understand the study details.
I live in a nursing home or am incarcerated.
I cannot use a smartphone or blood pressure device.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 guidan…
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).
Trial Locations
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Facility
City
State
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Status
Eligibility Criteria
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 categorize…
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.
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