Community-Informed Interventions for Equitable Congestive Heart Failure Management in Primary Care

NCT07730827 | Recruiting

• 1 other identifier: 25-013641
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to expand subject matter expertise and sustained capacity for equity-oriented care within the Advanced Care Ecosystem (ACE) by engaging patients, caregivers, community health workers (CHW), and care-team stakeholders in development work focused on adults living with congestive heart failure (CHF) and adverse social determinants of health (SDoH).

Conditions

Congestive Heart Failure; Heart Failure

Outcome Measures

Primary Outcomes (1)

• Identification of prioritized barriers to self-care

  Total number of prioritized barriers to equitable congestive heart failure self-care and transitions-of-care support identified through participant interviews and group discussions.

  Through study completion, an average of 2 years

Study Arms (3)

Adults living with congestive heart failure (CHF)

Adults living with CHF receiving primary care at Mayo Clinic Rochester with adverse SDoH, elevated utilization, or related medical/social complexity

Other: Interviews and group discussion for patients and caregivers

Caregivers or family members of eligible congestive heart failure (CHF) patients

Caregivers or family members of eligible CHF patients nominated by the patient

Other: Interviews and group discussion for patients and caregivers

Community health workers and care-team stakeholders

Community health workers, chronic disease RN care coordinators, education specialists, clinicians, and operational leaders

Other: Interviews and group discussion for community health worker and care-team stakeholders

Interventions

Interviews and group discussion for patients and caregivers OTHER

Participants will be asked to complete an individual interview or participate in a group discussion lasting approximately 60 to 120 minutes, conducted in person, by telephone, or by Mayo-approved video platform. Interview and discussion guides will include discussion of barriers, facilitators, preferences, priorities, and care gaps related to congestive heart failure self-care, access, transitions of care, community health worker support, caregiver support, social needs, health literacy, language access, trust, and culturally responsive care.

Adults living with congestive heart failure (CHF); Caregivers or family members of eligible congestive heart failure (CHF) patients

Interviews and group discussion for community health worker and care-team stakeholders OTHER

Participants will be asked to complete an individual interview or participate in a group discussion lasting approximately 60 to 120 minutes. Interview and discussion guides will focus on development of a community health worker competency-based training module and development of workflows for community health workers to support congestive heart failure patients' self-management and care transitions. Participants will provide feedback on implementation barriers and facilitators, including training burden, role clarity, sustainability, cultural responsiveness, and integration with clinical care teams.

Community health workers and care-team stakeholders

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will include adults with congestive heart failure (CHF) who receive primary care at Mayo Clinic in Rochester and have evidence of adverse social determinants of health, elevated health care utilization, or other medical or social complexity relevant to CHF self-care and transitions-of-care support. Eligible patients may nominate adult caregivers or family members to participate when their perspective is relevant to the patient's CHF care experience. The study will also include adult Community Health Workers, chronic disease nurse care coordinators, education specialists, clinicians, and other clinical or operational stakeholders with roles relevant to CHF care, transitions of care, social needs, patient education, or CHW workflows.

You may qualify if:

• Patients living with congestive heart failure (CHF):
• Age 18 years or older.
• Diagnosis or clinical documentation of CHF or heart failure in the Mayo Clinic medical record.
• Empaneled in Mayo Clinic, Rochester, primary care
• Evidence in the EHR of one or more adverse SDoH, elevated utilization, medical/social complexity.
• Able to provide informed consent.
• Able to participate in study procedures.
• Caregivers:
• Age 18 years or older.
• Caregiver with relevant lived, caregiving, or community experience related to CHF, and nominated by the patient.
• Able to provide informed consent
• Able to participate in study procedures.
• Community health worker and care-team stakeholders:
• Age 18 years or older.
• Current or recent role relevant to CHF care, transitions of care, SDoH, patient education, or CHW workflows.

You may not qualify if:

• Under age 18 years.
• Unable or unwilling to provide informed consent.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

MeSH Terms

Conditions

Heart Failure

Interventions

Interviews as Topic; Caregivers; Community Health Workers

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Health Personnel; Health Care Facilities Workforce and Services; Allied Health Personnel

Study Officials

• Majken T. Wingo, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

• Jane W. Njeru, MB, ChB

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amber Woltzen

CONTACT

507-422-6732; woltzen.amber@mayo.edu

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 23, 2026
• First Posted: July 28, 2026
• Study Start: July 6, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2029
• Last Updated: July 28, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)