Recruiting

NCT Number: NCT07730827

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

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).

Recruiting

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Key information

Conditions

Congestive Heart Failure Cardiovascular Diseases Heart Diseases Heart Failure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location status: Recruiting

Location contact

Amber Woltzen

CONTACT

[email protected]

507-422-6732

Jane W. Njeru, MB, ChB

PRINCIPAL_INVESTIGATOR

Majken T. Wingo, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.
Able to provide informed consent
Able to participate in study procedures.

Exclusion criteria

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

Treatment and study plan

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.

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.

Primary outcomes

Identification of prioritized barriers to self-care

Time frame: Through study completion, an average of 2 years

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

Study contacts

Contact information is provided by the study sponsor or research team.

Amber Woltzen

CONTACT

[email protected]

507-422-6732

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start: 2026
Primary completion: 2028
Study completion: 2029
First posted: Jul 28, 2026
Registry last updated: Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Recruiting