About this trial
Heart failure with preserved ejection fraction (HFpEF) accounts for approximately half of all heart failure cases and is associated with frequent hospitalizations, poor quality of life, and limited effective treatment options. Fragmented, single-discipline care often fails to address the multiple comorbidities and self-management needs of this population.
This study evaluates a Multidisciplinary Integrated Care Model (MICM) for patients with HFpEF, delivered by a coordinated team including cardiologists, case managers, pharmacists, dietitians, and rehabilitation specialists. The intervention group will receive structured team-based care, including regular follow-up, medication optimization, dietary and lifestyle counseling, and exercise guidance, in addition to standard cardiology care.
Using a prospective quasi-experimental design with a historical control group, this study compares clinical and patient-reported outcomes between patients receiving the multidisciplinary integrated care model and a historical cohort receiving usual care. The primary aim is to determine whether this integrated care approach improves outcomes such as heart failure-related hospitalization, functional status, and quality of life in patients with HFpEF.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 years or older
Hospitalized with a physician diagnosis of heart failure with preserved ejection fraction (HFpEF)
Left ventricular ejection fraction (LVEF) ≥50% on echocardiography performed during the index hospitalization
New York Heart Association (NYHA) functional class III to IV
Disqualifiers
Patients who elected hospice or palliative care as part of an advance care plan during the index hospitalization
Severe cognitive impairment without a family member or caregiver available to assist with the digital platform
Anticipated inability to complete post-discharge follow-up or lack of regular follow-up at the study institution's outpatient clinic
Length of index hospital stay less than 24 hours
Trial design
Parallel
Treatments tested in this trial
Multidisciplinary Integrated Care Model (MICM)
Other interventionA structured, team-based care program integrating cardiology management, case management, pharmacist-led medication review, nutritional counseling, and exercise guidance, delivered to patients with heart failure with preserved ejection fraction.
Usual Care
Other interventionStandard, non-integrated cardiology care as routinely provided prior to implementation of the multidisciplinary integrated care model.
Treatment groups
Trial outcomes
Primary outcomes
Length of Hospital Stay
Mean length of hospital stay, measured in days from hospital admission to discharge, among patients with heart failure with preserved ejection fraction (HFpEF), compared between the multidisciplinary integrated care intervention group and the historical usual care control group.
30-Day Hospital Readmission Rate
Proportion of participants readmitted to the hospital for any cause within 30 days of discharge, compared between the multidisciplinary integrated care intervention group and the historical usual care control group.
90-Day Hospital Readmission Rate
Proportion of participants readmitted to the hospital for any cause within 90 days of discharge, compared between the multidisciplinary integrated care intervention group and the historical usual care control group.
Secondary outcomes
Change in Quality of Life as Measured by the Minnesota Living with Heart Failure Questionnaire (MLHFQ)
Change in quality of life among patients with HFpEF following the multidisciplinary integrated care intervention, assessed using the Minnesota Living with Heart Failure Questionnaire (MLHFQ). The total score ranges from 0 to 105, with lower scores indicating better health-related quality of life and higher scores indicating worse health-related quality of life.
Change in Self-Care Ability as Measured by the Self-Care of Heart Failure Index v8.0 (SCHFI v8.0)
Change in self-care ability among patients with HFpEF following the multidisciplinary integrated care intervention, assessed using the Self-Care of Heart Failure Index version 8.0 (SCHFI v8.0), which includes three scales: self-care maintenance, symptom perception, and self-care management. Each scale is standardized to a score ranging from 0 to 100, with higher scores indicating better self-care ability.
Sponsors and contacts
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