Blended Collaborative Care to Treat Heart Failure and Comorbid Depression: Rationale and Study Design of the Hopeful Heart Trial

OBJECTIVE: Despite numerous improvements in care, morbidity from heart failure (HF) has remained essentially unchanged in recent years. One potential reason is that depression, which is comorbid in approximately 40% of hospitalized HF patients and associated with adverse HF outcomes, often goes unrecognized and untreated. The Hopeful Heart Trial is the first study to evaluate whether a widely generalizable telephone-delivered collaborative care program for treating depression in HF patients improves clinical outcomes. METHODS: The Hopeful Heart Trial aimed to enroll 750 patients with reduced ejection fraction (HFrEF) (ejection fraction ≤ 45%) including the following: (A) 625 patients who screened positive for depression both during their hospitalization (Patient Health Questionnaire [PHQ-2]) and two weeks following discharge (PHQ-9 ≥ 10); and (B) 125 non-depressed control patients (PHQ-2(-)/PHQ-9 < 5). We randomized depressed patients to either their primary care physician's "usual care" (UC) or to one of two nurse-delivered 12-month collaborative care programs for (a) depression and HFrEF ("blended") or (b) HrEFF alone (enhanced UC). Our co-primary hypotheses will test whether "blended" care can improve mental health-related quality of life versus UC and versus enhanced UC, respectively, on the Mental Component Summary of the Short-Form 12 Health Survey. Secondary hypotheses will evaluate the effectiveness of our interventions on mood, functional status, hospital readmissions, deaths, provision of evidence-based care for HFrEF, and treatment costs. RESULTS: Not applicable. CONCLUSIONS: The Hopeful Heart Trial will determine whether "blended" collaborative care for depression and HFrEF is more effective at improving patient-relevant outcomes than collaborative care for HFrEF alone or doctors' UC for HFrEF. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT02044211.