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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07730827
Enrollment
75
Registered
2026-07-28
Start date
2026-07-06
Completion date
2029-07-01
Last updated
2026-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congestive Heart Failure, Heart Failure

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).

Interventions

OTHERInterviews and group discussion for patients and caregivers

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.

OTHERInterviews and group discussion for community health worker and care-team stakeholders

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.

Sponsors

Mayo Clinic
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Identification of prioritized barriers to self-careThrough study completion, an average of 2 yearsTotal number of prioritized barriers to equitable congestive heart failure self-care and transitions-of-care support identified through participant interviews and group discussions.

Countries

United States

Contacts

CONTACTAmber Woltzen
woltzen.amber@mayo.edu507-422-6732
PRINCIPAL_INVESTIGATORMajken T. Wingo, MD

Mayo Clinic

PRINCIPAL_INVESTIGATORJane W. Njeru, MB, ChB

Mayo Clinic

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 29, 2026