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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
200
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.
Bremen Institute for Heart- and Circulation Research
Bremen, Germany
RECRUITINGCombined endpoint of rehospitalization (time to first event) and quality of life (QoL)
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
Time frame: 12 months
Combined endpoint of rehospitalization (time to first event) and quality of life (QoL)
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
Time frame: 24 months
all-cause mortality
all-cause mortality, defined as number of deaths of any cause that occur during the course of study
Time frame: 24 months
cardiovascular mortality
cardiovascular mortality, defined as number of deaths of cardiovascular cause that occur during the course of study, in particular death due to heart failure, myocardial infarction, stroke, sudden cardiac death
Time frame: 24 months
completeness of anticongestive medication
completeness of anticongestive medication, defined as use (0 = no, 1 = yes) of the four drug groups for heart failure (1. Angiotensin-converting enzyme inhibitor or angiotensin-1 receptor antagonist or angiotensin-1 receptor antagonist in combination with neprylisin inhibitor, 2. Beta blocker, 3. mineralocorticoid receptor antagonist, 4. Sodium-glucose-linked transporter 2 inhibitor) on a scale of 0 to 4 (0 = no substance group is taken, 1 = one substance group is taken, 2 = two substance groups are taken, 3 = three substance groups are taken, 4 = four substance groups are taken)
Time frame: 24 months
changes in ejection fraction
changes in ejection fraction, defined as delta in the percentage of left-ventricular ejection fraction measured at randomisation, after 12 month and after 24 months (delta %)
Time frame: 24 months
NTproBNP
defined as delta in NTproBNP (N-terminal pro-brain natriuretic peptide)-levels measured in nanogram per litre (ng/l) between hospitalisation, 12 months and 24 months
Time frame: 24 months
ferritin and transferrin levels
defined as delta in ferritin-levels measured in microgram per litre (ug/l) and transferrin-levels measured in gram per litre (g/l) between hospitalisation, 12 months and 24 months
Time frame: 24 months
6-minute walking distance
defined as delta in the distance (measured in meters) a patient can walk in a standardised 6-minute walking distance between hospitalisation, 12 months and 24 months
Time frame: 24 months
relative maximum oxygen-consumption (peak VO2)
defined als delta in the relative maximum oxygen-consumption (peak VO2, ml/min/kg) measured by standardised cardiopulmonary exercise test between hospitalisation, 12 months and 24 months
Time frame: 24 months
NYHA class
defined as delta in the New-York-Heart-Association (NYHA) class between randomisation, 12 months and 24 months, whereby NYHA-class is defined on a scale from 1 to 4: 1 (no limitation): Normal physical exertion causes no symptoms, 2 (mild limitation): No symptoms at rest, but symptoms occur during normal, more strenuous exertion (e.g., climbing stairs, 3 (significant limitation): No symptoms at rest, but symptoms occur even with light physical exertion (e.g., walking on level ground), 4 (severe limitation): Symptoms occur even at rest, bedridden possible.
Time frame: 24 months
quality of life (points in KCCQ-12)
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
Time frame: 24 months
depression status (points in PHQ-9)
defined as delta in the total score in the standardised PHQ-9-questionnaire that indicates the severity of depressive symptoms between hospitalisation, 12 months and 24 months. The total score ranges from 0 to 27 points. Higher scores correspond to more severe symptoms: 0-4: No to minimal symptoms, 5-9: Mild depression, 10-14: Moderate depression. 15-19: Severe depression. 20-27: Severe depression
Time frame: 24 months
score for self-care in dealing with heart failure (EHFScBS)
defined as delta in the total score in the standardised EHFScBS-questionnaire to measure the self-care behavior of patients with heart failure between hospitalisation, 12 months and 24 months. The questionnaire consists of 9 questions for self-care in dealing with heart failure that are answered on a Likert scale from 1 ("I completely agree") to 5 ("I completely disagree"). The sum of the 9 items results in a score between 9 and 45 points. A lower raw score indicates better self-care behavior (fewer problems in everyday life), while a higher raw score indicates poorer self-care behavior and greater deficits. The delta of total points between hospitalisation, 12 months and 24 months is measured.
Time frame: 24 months
number of correct answers in the AHFKT questionnaire
defined as delta in the number of correct answers in the Atlanta Heart Failure Knowledge Test (AHFKT) questionnaire between hospitalisation, 12 months and 24 months. The Atlanta Heart Failure Knowledge Test is a valid tool for measuring patients' knowledge about their own chronic heart failure. It contains of 30 questions with the option of answering either yes or no or selecting one of four possible answers, with only one answer being correct in each case. 0 points indicates the worst/no knowledge of heart failure, while 30 points indicates the best knowledge of heart failure.
Time frame: 24 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.