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Using Lay Health Advisors to Improve Hypertension Management

Sponsor
MetroHealth Medical Center (Other)
Overall Status
Terminated
CT.gov ID
NCT03515005
Collaborator
(none)
69
Enrollment
1
Location
2
Arms
8.9
Actual Duration (Months)
7.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Lay Health Advisor
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
69 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Using Lay Health Advisors to Help African Americans Address the Social Context of Hypertension Management
Actual Study Start Date :
Dec 3, 2018
Actual Primary Completion Date :
Sep 1, 2019
Actual Study Completion Date :
Sep 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Lay Health Advisors

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

Behavioral: Lay Health Advisor
Patients will meet regularly Lay Health Advisors who will address the social context of their hypertension.
No Intervention: Usual Care

Control patients will receive usual care from their doctors.

Outcome Measures

Primary Outcome Measures

  1. Change in systolic and diastolic blood pressure [1 year]

    Difference between final and initial systolic and diastolic blood pressure readings

Secondary Outcome Measures

  1. 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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 64 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 The MetroHealth System Cleveland Ohio United States 44109

Sponsors and Collaborators

  • MetroHealth Medical Center

Investigators

  • Principal Investigator: John D Thornton, MD, MPH, The MetroHealth System

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Daryl Thornton, MD, Investigator, MetroHealth Medical Center
ClinicalTrials.gov Identifier:
NCT03515005
Other Study ID Numbers:
  • IRB18-00038
First Posted:
May 3, 2018
Last Update Posted:
Apr 14, 2021
Last Verified:
Apr 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Daryl Thornton, MD, Investigator, MetroHealth Medical Center
Hypertension
Community Health Workers
Community-Based Participatory Research
Health Equity
Additional relevant MeSH terms:
Hypertension

Study Results

No Results Posted as of Apr 14, 2021