Recruiting

Observational Study

Sponsor:

Mayo Clinic

Code:

NCT07730827

Conditions

Congestive Heart Failure

Heart Failure

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Interviews and group discussion for patients and caregivers

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

Study Details

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

Study ID

NCT07730827

Start date

Jul 6, 2026

Status verified date

Jul, 2026

Completion date

Jul, 2029

Anticipated

Primary completion date

Jul, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

75 participants

Anticipated

Interventions and Outcome Measures

Arms

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

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

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

Community health workers and care-team stakeholders

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

Interventions

Interviews 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.

Interviews 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.

Primary outcome measure

  • Identification of prioritized barriers to self-care [ Time Frame: Through study completion, an average of 2 years ]

Central Contacts and Locations

Central contacts

Amber Woltzen

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

Locations

Mayo Clinic

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Amber Woltzen

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

Principal Investigator:

Majken T. Wingo, MD

More Information

Sponsor

Mayo Clinic

Last update posted

Jul 28, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-07-28.