Using Lay Health Advisors to Improve Hypertension Management

Not Applicable

Terminated

• Conditions: Hypertension
• Interventions: Behavioral: Lay Health Advisor

• Registration Number: NCT03515005
• Lead Sponsor: MetroHealth Medical Center

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.

Study Timeline

• Study First Submitted: 2018-03-29
• Study First Submitted QC: 2018-04-21
• Study First Posted: 2018-05-03
• Study Start: 2018-12-03
• Primary Completion: 2019-09-01
• Study Completion: 2019-09-01
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-09
• Last Update Posted: 2021-04-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 69

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lay Health Advisors	Lay Health Advisor	Intervention patients will meet monthly in small groups with a trained Lay Health Advisor.

Primary Outcome Measures

Name	Time	Method
Change in systolic and diastolic blood pressure	1 year	Difference between final and initial systolic and diastolic blood pressure readings

Secondary Outcome Measures

Name	Time	Method
Change in quality of life.	1 year	Differences in quality of life between final and initial measurements using the 12 item short form survey (SF-12). The SF-12 provides physical and mental health composite scores ranging from 0 (lowest level of health) to 100 (highest level of health)

Trial Locations

Locations (1)

The MetroHealth System; 🇺🇸 Cleveland, Ohio, United States