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.