Community Health Workers Reduce Social Barriers That Affect the Health of Patients With High Blood Pressure and Diabetes.
NCT06926855 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3120
Last updated 2026-03-04
Summary
The goal of this mixed-methods study is to assess the impact of a Community Health Worker (CHW)-led social risk screening and referral in improving management of uncontrolled diabetes (DM) and hypertension (HTN) among patients receiving care in community health centers (CHCs or health centers). The intervention is focused on adult health center patients with uncontrolled DM and/or HTN. Study findings will provide important evidence to guide CHCs in implementing programs to address social risks in their patient populations. Findings will illuminate whether and how CHW-led interventions to address social needs yield the hypothesized outcomes. The aims of the study are:
* AIM 1: Measure how effective the CHW-led social risk program is at reducing blood sugar levels (A1C) in CHC patients with uncontrolled DM and lowering blood pressure in CHC patients with uncontrolled HTN.
* AIM 2: Identify effective strategies for increasing and expanding CHW-led social risk programs.
Conditions
- Uncontrolled Diabetes
- Uncontrolled Hypertension
Interventions
- OTHER
-
CHC-level cluster randomized control trial
CHW (with clinic champion support) outreach to eligible patients, verbally consent patients, confirm eligibility, conduct social needs screening, make service or resource referrals, plan and support referral completion as needed, follow-up with patients to assess referral completion and outcomes Implementation supports: financial support for CHW, clinic champion, and CHC administration of trial activities; 12 weeks of preparatory CHW training and coaching; practice coaching and technical support for data collection at all sites; additional support for sites without existing research data infrastructure; CHW Learning Collaborative through intervention and follow-up period for implementation support and cross-training control sites.
Sponsors & Collaborators
-
Health Choice Network
collaborator OTHER -
OCHIN, Inc.
collaborator OTHER -
National Institutes of Health (NIH)
collaborator NIH -
National Heart, Lung, and Blood Institute (NHLBI)
collaborator NIH -
Westat
collaborator OTHER -
National Institute on Minority Health and Health Disparities (NIMHD)
collaborator NIH -
Morehouse School of Medicine
lead OTHER
Principal Investigators
-
Megan Douglas, JD · Morehouse School of Medicine
-
Rachel Gold, PhD, MPH · OCHIN, Inc.
-
Katherine Chung-Bridges, MD, MPH · Health Choice Network (HCN)
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SCREENING
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-05-01
- Primary Completion
- 2026-04-30
- Completion
- 2026-06-30
Countries
- United States
Study Locations
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