Congestive Heart FailureNCT07730827
Community-Informed Interventions for Equitable Congestive Heart Failure Management in Primary Care
An observational study of Congestive Heart Failure and Heart Failure, run by Mayo Clinic at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Congestive Heart Failure, Heart Failure
- What is being tested?
- Interviews and group discussion for patients and caregivers and Interviews and group discussion for community health worker and care-team stakeholders
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jul 2026to Jul 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
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- 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.
Who cannot join
- Under age 18 years.
- Unable or unwilling to provide informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Amber Woltzen, 507-422-6732, woltzen.amber@mayo.edu
Majken T. Wingo, MD
About this study
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
- Being tested
- Interviews and group discussion for patients and caregivers, Interviews and group discussion for community health worker and care-team stakeholders
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interviews and group discussion for patients and caregiversOther
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 stakeholdersOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: Other: Interviews and group discussion for community health worker and care-team stakeholders |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2026
- Study start6 Jul 2026
- Primary completionJul 2028 (estimated)
- Study completionJul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congestive Heart FailureStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Majken Wingo, Mayo Clinic
- Investigators
- Majken T. Wingo, MD, Principal investigator, Mayo ClinicJane W. Njeru, MB, ChB, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07730827
- Sponsor's protocol ID
- 25-013641
- Status last verified
- Jul 2026
- First submitted
- 23 Jul 2026
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community-Informed Interventions for Equitable Congestive Heart Failure Management in Primary Care
- ClinicalTrials.gov ID
- NCT07730827
- Acronym / sponsor ID
- 25-013641
- Conditions
- Congestive Heart Failure, Heart Failure
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 6 Jul 2026 (actual)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Jul 2029 (estimated)
- First posted
- 28 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Adults living with congestive heart failure (CHF) | – | Other: Interviews and group discussion for patients and caregiversAdults 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 | – | Other: Interviews and group discussion for patients and caregiversCaregivers or family members of eligible CHF patients nominated by the patient |
| Community health workers and care-team stakeholders | – | Other: Interviews and group discussion for community health worker and care-team stakeholdersCommunity health workers, chronic disease RN care coordinators, education specialists, clinicians, and operational leaders |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (17 listed)
- 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.
Key exclusion criteria (2 listed)
- Under age 18 years.
- Unable or unwilling to provide informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interviews and group discussion for patients and caregiversParticipants 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 | 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 stakeholdersParticipants 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. | Other | Community health workers and care-team stakeholders |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Majken T. Wingo, MD principal investigator
Mayo Clinic
Jane W. Njeru, MB, ChB principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congestive Heart Failure and Heart Failure, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amber Woltzen (507-422-6732, woltzen.amber@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of prioritized barriers to self-care (time frame: Through study completion, an average of 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.