The Health for Hearts United Collaborative (HHUC)

Florida State University

Status: Invitation-only

Conditions: Cardiovascular Disease Risk Reduction

Treatments: Behavioral: Health for Hearts United Planning for Health; Behavioral: Health for Hearts United Preparing for Health; Other: Health for Hearts United Comparison Group Health Ministry Development; Behavioral: Health for Hearts United Delivery of Health

Study type: Interventional

Funder types: Other

Identifiers

NCT05259150

STUDY00000409

Details and patient eligibility

About

This proposed project will determine the effectiveness of Health for Hearts United Collaborative (HHUC) implementation strategies in relation to process outcomes and reducing cardiovascular disease (CVD) risk in African Americans (AAs),examining two possible strategies.

Full description

This project will determine the effectiveness of HHUC implementation strategies in relation to process outcomes and reducing CVD risk in AAs, guided by ecological theory, the Consolidated Framework for Implementation Research (CFIR), and the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) framework. The HHUC model currently includes three components: governance structure, annual events, and basic support. The investigators propose adding a fourth component that includes one of two possible implementation strategies: 1) an internal champions (IC)-driven strategy that includes two features (leadership development, culturally-tailored planning approaches) or 2) an external change agent (external professionals [EP])-driven strategy without these features. The investigators will pilot and refine the IC and EP-driven implementation strategies using health leaders from four churches in the two-county area by determining feasibility and acceptability. Following the pilot, the investigators will use an effectiveness implementation hybrid Type 3 design to evaluate the IC and EP implementation strategies in relation to process outcomes. The study will be conducted in a two-county area in North Florida, using congregants ((18 years of age and older, n=225) in nine churches: three IC treatment, three EP treatment, and three comparison with delayed comparable activities.

Enrollment: 225 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• African American,
• 18 years of age and older,
• not pregnant in the last six months,
• not hospitalized or having a clinically significant medical condition in the past six months

Exclusion criteria

• not being African American,
• under the age of 18,
• pregnant in the last six months,
• hospitalized or having a clinically significant medical condition in the past six months.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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225 participants in 3 patient groups

Internal Champion (IC) Strategy

Experimental group

Description:

In the Planning for Health intervention, the IC implementation strategy will include trainings on transformational leadership principles that address challenges that health leaders face in the church setting to assist them in independently planning the cardiovascular health programming for congregants. Limited assistance from staff will be provided in the Preparing for Health and the Delivery of Health interventions.

Treatment:

Behavioral: Health for Hearts United Delivery of Health

Behavioral: Health for Hearts United Preparing for Health

Behavioral: Health for Hearts United Planning for Health

Expert Professional (EP) Strategy

Experimental group

Description:

In the Planning for Health intervention, the EP implementation strategy will include the use of external professionals to assist health leaders in the planning of cardiovascular health programming for congregants. Staff will assist health leaders in the Preparing for Health and the Delivery of Health interventions.

Treatment:

Behavioral: Health for Hearts United Delivery of Health

Behavioral: Health for Hearts United Preparing for Health

Behavioral: Health for Hearts United Planning for Health

Comparison Group Strategy

Active Comparator group

Description:

In the Planning for Health intervention, the Comparison Group strategy will include process activities with the health leaders (identification of health leaders, meetings of health leaders, assistance of health leaders with recruitment of congregants for research). Except for data collection, participants (health leaders and congregants) will not be involved in the Preparing for Health or the Delivery of Health interventions.

Treatment:

Other: Health for Hearts United Comparison Group Health Ministry Development