HI-PLUS: design of a cluster-randomized trial evaluating structured case management with telemonitoring to improve quality of life in heart failure

INTRODUCTION: Heart failure (HF) remains a leading cause of hospitalization and death in Germany, significantly impairing patients' quality of life (QoL) despite advances in therapy. Structured, multidisciplinary care programs may improve long-term outcomes. HI-PLUS is a pragmatic trial investigating whether a complex intervention can improve QoL in HF patients. We describe the trial design and pilot feasibility study findings. METHODS AND RESULTS: HI-PLUS is a cluster-randomized, parallel-arm controlled trial (DRKS00031997) targeting 56 clusters, each comprising a cardiology practice and up to five general practitioners (GPs), targeting 1350 patients. The control arm receives guideline-recommended care. The intervention adds five elements: (a) care supported by specially trained non-physician staff HF qualified (HF-MPA); (b) accredited HF-MPA training curriculum certified by the German Society of Cardiology; (c) eHealth platform for telemonitoring and symptom reporting; (d) portable telemedical devices, if needed; and (e) enhanced communication between cardiologists and GPs facilitated by HF-MPAs and the eHealth platform. The primary endpoint is change in HF-specific QoL after 12 months, measured by the Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OSS). A pilot feasibility study that was conducted prior to commencement of patient recruitment confirmed the feasibility and acceptability of the proposed trial procedures. CONCLUSION: The HI-PLUS trial addresses recognized gaps in HF care. If effective, it could serve as a scalable model for integrated HF care throughout Germany.