[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07730827":3,"trial-entities:NCT07730827":91,"trial-summary:NCT07730827":94},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":20,"study_type":21,"primary_purpose":16,"phases":22,"enrollment_info":23,"interventions":26,"primary_outcomes":38,"secondary_outcomes":43,"sex":44,"minimum_age":45,"maximum_age":16,"healthy_volunteers":14,"eligibility_criteria":46,"std_ages":61,"locations":64,"central_contacts":84,"overall_officials":86,"references":89,"see_also_links":90},"NCT07730827","25-013641","Community-Informed Interventions for Equitable Congestive Heart Failure Management in Primary Care","RECRUITING","2029-07","2026-07","2026-07-28","2026-07-06","Mayo Clinic","OTHER",false,"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).",null,[18,19],"Congestive Heart Failure","Heart Failure",[],"OBSERVATIONAL",[],{"count":24,"type":25},75,"ESTIMATED",[27,33],{"type":13,"name":28,"description":29,"armGroupLabels":30},"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.",[31,32],"Adults living with congestive heart failure (CHF)","Caregivers or family members of eligible congestive heart failure (CHF) patients",{"type":13,"name":34,"description":35,"armGroupLabels":36},"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.",[37],"Community health workers and care-team stakeholders",[39],{"measure":40,"description":41,"timeFrame":42},"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.","Through study completion, an average of 2 years",[],"ALL","18 Years",{"inclusion":47,"exclusion":57,"raw_text":60},[48,49,50,51,52,53,48,54,55,53,48,56,55,53],"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\u002Fsocial complexity.","Able to provide informed consent.","Able to participate in study procedures.","Caregiver with relevant lived, caregiving, or community experience related to CHF, and nominated by the patient.","Able to provide informed consent","Current or recent role relevant to CHF care, transitions of care, SDoH, patient education, or CHW workflows.",[58,59],"Under age 18 years.","Unable or unwilling to provide informed consent.","Inclusion Criteria:\n\nPatients living with congestive heart failure (CHF):\n\n* Age 18 years or older.\n* Diagnosis or clinical documentation of CHF or heart failure in the Mayo Clinic medical record.\n* Empaneled in Mayo Clinic, Rochester, primary care\n* Evidence in the EHR of one or more adverse SDoH, elevated utilization, medical\u002Fsocial complexity.\n* Able to provide informed consent.\n* Able to participate in study procedures.\n\nCaregivers:\n\n* Age 18 years or older.\n* Caregiver with relevant lived, caregiving, or community experience related to CHF, and nominated by the patient.\n* Able to provide informed consent\n* Able to participate in study procedures.\n\nCommunity health worker and care-team stakeholders:\n\n* Age 18 years or older.\n* Current or recent role relevant to CHF care, transitions of care, SDoH, patient education, or CHW workflows.\n* Able to provide informed consent\n* Able to participate in study procedures.\n\nExclusion Criteria:\n\n* Under age 18 years.\n* Unable or unwilling to provide informed consent.",[62,63],"ADULT","OLDER_ADULT",[65],{"facility":12,"status":7,"city":66,"state":67,"zip":68,"country":69,"contacts":70,"geoPoint":81},"Rochester","Minnesota","55905","United States",[71,76,79],{"name":72,"role":73,"phone":74,"email":75},"Amber Woltzen","CONTACT","507-422-6732","woltzen.amber@mayo.edu",{"name":77,"role":78},"Majken T. Wingo, MD","PRINCIPAL_INVESTIGATOR",{"name":80,"role":78},"Jane W. Njeru, MB, ChB",{"lat":82,"lon":83},44.02163,-92.4699,[85],{"name":72,"role":73,"phone":74,"email":75},[87,88],{"name":77,"affiliation":12,"role":78},{"name":80,"affiliation":12,"role":78},[],[],{"nct_id":4,"conditions":92,"biomarkers":93},[18],[],{"nct_id":4,"found":95,"summary":96,"prompt_version":106},true,{"design":97,"status":98,"heading":99,"summary":100,"follow_up":101,"word_count":102,"commitments":103,"compensation":104,"drugs_mentioned":105},"This is an observational study, meaning researchers will gather information without testing a new treatment. It involves about 75 participants.","completed","Community-Informed Interventions for Congestive Heart Failure Management","This study aims to improve care for adults living with congestive heart failure (CHF) who also face challenges related to social determinants of health (SDoH), such as housing or food insecurity. Researchers will gather information through interviews and group discussions with patients, caregivers, community health workers, and care team members. The goal is to understand what makes it hard or easy for people to manage their CHF and to develop better training and workflows for healthcare teams. This study is looking for about 75 participants aged 18 or older who have a CHF diagnosis and receive primary care at Mayo Clinic, Rochester, with documented SDoH challenges. The main goal is to identify the biggest challenges patients face in taking care of themselves.","The study will identify barriers to self-care over an average of two years.",122,"You would participate in an individual interview or a group discussion lasting approximately 60 to 120 minutes. These can be in person, by phone, or by video.","Not stated in the trial record.",[],"v2"]