Clinical trial NCT03515005: Using Lay Health Advisors to Improve Hypertension Management
Official title: Using Lay Health Advisors to Help African Americans Address the Social Context of Hypertension Management
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hypertension
Keywords: Hypertension
Community Health Workers
Community-Based Participatory Research
Health Equity
Lead sponsor: MetroHealth Medical Center
Sponsor class: OTHER
First posted: 2018-05-03
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Hypertension disproportionately affects and is inadequately controlled among African American and poor populations. The investigators propose to determine the impact of using trained lay health advisors to help patients address social contextual factors that influence the management of hypertension.

Detailed description: Hypertension disproportionately affects and is inadequately controlled among African American and poor populations. Health providers generally lack the skills and resources to address social contextual factors (i.e. health and community services, social networks, social stressors, physical environment, and economic resources) that influence management of hypertension. Instead, providers tend to focus on adjusting antihypertensive medication prescriptions and exhorting patients to exercise and eat better. The investigators propose to determine the impact of using trained lay health advisors to help patients address social contextual factors that influence the management of hypertension. Helping patients address these barriers may lead not only to improved blood pressure but also to increased survival, reduced organ damage, and decreased health care costs. This project may also serve as a model of healthcare delivery innovation that could be used to address other health disparity conditions.

Eligibility criteria: Inclusion Criteria:

* At least 2 outpatient blood pressures with systolic \>140 or diastolic \>90 mm Hg in last 6 months. Separate occurrences at least 1 day apart
* Age 18-59 years
* Non-diabetic
* Preserved kidney function (glomerular filtration rate \>60 ml/min)
* English speaking

Exclusion Criteria:

* Mentally incompetent
* Pregnant
* Terminal illness
* Active substance abuse
* Documented coronary, peripheral arterial, or cerebrovascular disease

Primary outcomes:
measure: Change in systolic and diastolic blood pressure
timeFrame: 1 year
Secondary outcomes:
measure: Change in quality of life.
timeFrame: 1 year
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: The MetroHealth System
state: Ohio
Study officials:
affiliation: MetroHealth System, Ohio
name: John D Thornton, MD, MPH
role: PRINCIPAL_INVESTIGATOR
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