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Active Comparator Control 1 / Heart Failure / Caregiver · Phase 2 Trial
ClinicalTrials.gov · September 4, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a Phase 2 trial registration for HEROIC, a nurse-led palliative care intervention for caregivers of advanced heart failure patients. No results are posted in this registry record; the study is not yet recruiting. The planned design includes 500 participants across multiple sites with three primary outcome measures assessed at 12 weeks (caregiver mental health, patient quality of life) and 1 year (unplanned acute care visits).
Phase 2, Interventional, Randomized, Parallel, Double masking, Supportive Care purpose. Heart Failure, Caregiver; age from 18 Years. Intervention: HEROIC program. Compared with: Control condition — Active Comparator. n = 500. 2 sites: United States.
This is a Phase 2 trial registration for HEROIC, a nurse-led palliative care intervention for caregivers of advanced heart failure patients. No results are posted in this registry record; the study is not yet recruiting. The planned design includes 500 participants across multiple sites with three primary outcome measures assessed at 12 weeks (caregiver mental health, patient quality of life) and 1 year (unplanned acute care visits).
No effect sizes, safety data, or interim findings are reported.
The source did not state who this applies to in practice.
This is a Phase 2 trial registration with no results posted; the study is not yet recruiting and therefore carries no outcome data to evaluate.
As stated by the source record.
Quoted from the source exactly as published.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT07805811). This is a study registration, not published results. Lead sponsor: Johns Hopkins University. Recruitment status: NOT_YET_RECRUITING. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 500 participants (ESTIMATED). Conditions: Heart Failure, Caregiver. Interventions: BEHAVIORAL: HEROIC program; BEHAVIORAL: Active Comparator Control 1. Primary outcome measures: Mental Health (caregiver) as assessed by the Short Form Health Survey (SF-36) , 12 weeks; Health-related quality of Life (patient) as assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ-12) , 12 weeks; Number of unplanned acute care (patient) visits , 1 year. Brief summary: This study will test the mechanisms of a multi-component, nurse-led, primary palliative care intervention, HEart failure Resilience Intervention for Caregivers (HEROIC) to improve caregiver mental well-being, patient health-related quality of life and unplanned acute care in the setting of advanced heart failure. The investigators will conduct a multi-site, randomized controlled trial to test proposed mechanisms of action in a large sample (N=500) of persons with heart failure and the caregivers. The investigators will also examine variation in response to HEROIC components by heart failure subgroup (ventricular assist device, heart transplant or medically managed heart failure).
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.