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Using Lay Health Advisors to Improve Hypertension Management

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03515005
Recruitment Status : Enrolling by invitation
First Posted : May 3, 2018
Last Update Posted : March 1, 2019
Sponsor:
Information provided by (Responsible Party):
Daryl Thornton, MD, 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.

Condition or disease Intervention/treatment Phase
Hypertension Behavioral: Lay Health Advisor Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 312 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 : December 3, 2018
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. Change in systolic and diastolic blood pressure [ Time Frame: 1 year ]
    Difference between final and initial systolic and diastolic blood pressure readings


Secondary Outcome Measures :
  1. Change in quality of life. [ Time Frame: 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)



Information from the National Library of Medicine

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03515005


Locations
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United States, Ohio
The MetroHealth System
Cleveland, Ohio, United States, 44109
Sponsors and Collaborators
MetroHealth Medical Center
Investigators
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Principal Investigator: John D Thornton, MD, MPH The MetroHealth System

Publications:

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Responsible Party: Daryl Thornton, MD, Investigator, MetroHealth Medical Center
ClinicalTrials.gov Identifier: NCT03515005     History of Changes
Other Study ID Numbers: IRB18-00038
First Posted: May 3, 2018    Key Record Dates
Last Update Posted: March 1, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Daryl Thornton, MD, MetroHealth Medical Center:
Hypertension
Community Health Workers
Community-Based Participatory Research
Health Equity
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases