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Introduction <p>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.</p> Methods and results <p>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&#xa0;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.</p> Conclusion <p>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.</p> Graphical Abstract <p></p>

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

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  • 发表日期：

    2026年4月27日

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  • Martha Schutzmeier,
  • Viktoria Rücker,
  • Jonas Widmann,
  • Peer Papior,
  • Lisa Kimmelmann,
  • Fabian Kerwagen,
  • Lorenz Heil,
  • Helena Manger,
  • Andrea Szczesny,
  • Yannick Maaser,
  • Bettina Zippel-Schultz,
  • Thomas Helms,
  • Peter U Heuschmann,
  • Stefan Störk

摘要

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.

Graphical Abstract