Effects of a dyadic empowerment-based heart failure management program (De-HF) on patient-reported and clinical outcomes: a double-blind randomized controlled trial

Abstract Background Heart failure (HF) a significant public health challenge, imposing substantial impact on patient-reported outcomes and health service utilization. With the evolvement of dyadic science, transitional care has to optimize the dyadic approach in disease management Purpose This double-blind RCT aims to investigate the effect of a Dyadic Empowerment-based HF management program (De-HF) on the care collaboration and health outcomes of the care dyads. Methods We randomized 160 HF care-dyads (patient and caregiver) who discharged from regional hospitals to either the 16-week De-HF program or the conventional HF education program. The De-HF program comprised a) dyadic assessment home visit; b) five online-based empowerment module covering evidence-based disease management topics; and c) nurse-led follow up telecare. The outcome measures included Minnesota Living with Heart Failure Questionnaire (MLHFQ), Self-Care Heart failure Index (SCHFI), Shared Care Instrument Revised version 3 (SCI-3) and Control Attitude Scale Revised (CASR) at baseline (T0), posttest-16th week (T1), -24th week (T2), and -32nd week (T3). Results Of the 160 HF patients mean age (SD) = 74.2 (11.1); NYHA classification: II/III/IV 50%/46.9%/3.1%; Charlson Comorbidity Index mean score = 6.1 (2.1), LVEF mean % = 41.3 (16.1), mean time of HF diagnosis 43.3 (56.7) months, the attrition rate at the latest assessment point T3 was 8.75%. Figure 1 shows the CONSORT Flow Chart. After adjusting the clinical-demographic profile, generalized estimation equation showed significantly group*time interaction effects at all timepoints, with the De-HF group reported more improvement in all self-care domains [GEE β (95%CI @ T3): self-care maintenance= 0.28(0.11-0.45), P=0.001; self-care management=9.94(5.28-14.59), P.001; symptom perception=14.11 (8.50-19.72), P.001, patient’s HRQL GEE β (95%CI@T3): MLHFQ=-10.21 (-15.99 to -4.44), P.001. As for the dyadic outcomes, the care dyads showed greater improvement in sense of control GEE β (95%CI): CASR(patient)=4.65 (2,52-6.78), P.001; CASR(caregiver)= 6.44 (4.28 to 8.61), P.001 and shared care GEE β (95%CI@T3): SCI-3(patient communication)=0.38(0.10-0.65), P=0.008; SCI-3(patient decision making)=0.32 (0.02-0.62), P=0.034; SCI-3(patient reciprocity)=0.29 (0.04 to 0.54), P=0.024. The SCI-3 of the caregivers showed significant improvement in all domains as well. Conclusion This study indicated the positive effects of DE-HF Program on the health outcomes and collaborative care among HF patients and their caregivers in the post-discharge period. The study suggest the importance of integrating collaborative dyadic care in optimizing the HF post-discharge management