Intensive Prevention Program After Decompensated Heart Failure

Condition(s) studied

Investigational drug(s) / intervention(s)

Web-based patient portal for self learning about heart failure: E-learning program: the patient receives personal access to a study-specific website that provides training content on the topic of heart failure. The individual training modules build on each other. Access to the modules is controlled via HFN: once a module has been completed and, if applicable, a learning assessment has been successfully passed (depending on the module), the HFN will unlock the next training content. The patient should complete the program in the first 6 months of the study (and recap in the second half of the year). The program focusses on deepening what was trained in hospital. Additionally, an on-site appointment, ideally with relatives, is organized for resuscitation training. \- E-training program: in addition to the theoretical learning content, the website also features training videos that show training programs specially adapted for heart failure patients, enabling them to engage in regular, ideally daily, structured home training.

Study summary

Introduction: Care for patients with heart failure (HF) often remains inadequate, even though a variety of treatment options exist. Guideline-based, multimodal therapy is rarely fully established, partly due to insufficient intersectoral cooperation and insufficient patient training. Heart failure nurses (HFN) as specialized non-medical personnel are intended to contribute to better patient care. E-learning and the use of mobile devices are modern options for training patients. However, previous studies in this regard only examined a few aspects of therapy and came to different results. The Intensive Prevention Program after decompensated Heart Failure (IPP-HF) will investigate if a one-year web-based and HFN-guided program for patients hospitalized due to congestive heart failure leads to a lower rate of re-hospitalization and an improvement in quality of life (QoL).

Study design: Patients hospitalized for decompensated HF will be prospectively enrolled and assigned to either a 12 months HFN-guided intensive prevention program or standard care. The prevention program will include patient training per e-learning, use of an app for HF, linking the patient to an interdisciplinary heart failure network and referral to heart sports groups or other specialists and will include regular monitoring for signs of (threatening) decompensation, medication, fitness and QoL. The combined primary study endpoint will comprise rehospitalization for decompensated HF and QoL after 1 year. Secondary endpoints will include mortality, completeness of anticongestive medication, changes in ejection fraction, NTproBNP, ferritin, transferrin, 6-minute walking distance, relative maximum oxygen-consumption (peak VO2), NYHA-class, depression status (PHQ-9) and knowledge about HF (AHFKT).

Conclusions :The randomized IPP-HF study will evaluate the effect of an web-based and HFN-guided prevention program on rehospitalization and QoL for patients hospitalized for decompensated heart failure.

Eligibility

Primary outcome measure(s)

• Combined endpoint of rehospitalization (time to first event) and quality of life (QoL) — 12 months
  Combined endpoint of rehospitalization (time to first event) and quality of life (QoL) measured by total points in the validated Kansas City Cardiomyopathy Questionnaire (KCCQ-12) with 0 points meaning badest QoL possible an 100 points best QoL possible. Interpretation of KCCQ-12 total scores: 0-24: Very poor to poor, 25-49: Poor to moderate, 50-74: Moderate to good, 75-100: Good to excellent

Trial sites (1)

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