NCT07730827 · Mayo Clinic
Community-Informed Interventions for Equitable Congestive Heart Failure Management in Primary Care
What this study is about
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).
View original scientific description
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
OTHER
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.
OTHER
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 measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Rochester, Minnesota
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 28, 2026 · Source of record for eligibility and locations