Collaborate and Leverage Evidence in African American Rural Network (Co-LEARN)

University of North Carolina (UNC)

Status: Active, not recruiting

Conditions: Cardiovascular Diseases

Treatments: Behavioral: Heart Matters

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT06730633

21-1366

5R01HL157255 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The goal of this non-randomized, propensity-matched-controlled study is to assess the effectiveness of the Heart Matters evidence-based program -- previously evaluated for feasibility and efficacy in NCT02707432 -- in improving cardiovascular health outcomes (change in systolic and diastolic blood pressure, primary outcomes) when implemented by community-based facilitators.

Full description

The research team will use a non-randomized, propensity-matched-controlled design to evaluate the effectiveness of the Heart Matters evidence-based program -- previously evaluated for feasibility and efficacy under NCT02707432 -- in improving cardiovascular health outcomes when scaled in multiple rural, eastern North Carolina counties and implemented by community-based facilitators.

This study aims to recruit 210 participants, 70 of whom will be propensity-score-matched with participants from NCT02707432. Propensity-score-matching will allow for flexibility in recruitment, statistical rigor, and resource efficiency. The research team hypothesizes that matched participants in the present study will show significant improvements in health outcomes (systolic blood pressure, diastolic blood pressure) compared to the matched NCT02707432 controls.

Enrollment: 173 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Identify as Black or African American
• Reside in rural, eastern North Carolina
• Self-report at least one cardiovascular disease risk factor, such as pre-diabetes, pre-hypertension or stage one hypertension, obesity, or family history of early heart disease

Exclusion criteria

• Evidence of active or unstable cardiovascular disease
• Cognitive impairment that limits informed consent

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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173 participants in 2 patient groups

Intervention Group

Experimental group

Description:

This group will receive the Heart Matters intervention, delivered by community-based facilitators. All participants consenting to the present study will be assigned to this arm.

Treatment:

Behavioral: Heart Matters

Propensity-matched Control Group (Retrospective)

Active Comparator group

Description:

This group received the Heart Matters intervention, delivered by researchers, under NCT02707432.

Treatment:

Behavioral: Heart Matters