An interventional study of Multidisciplinary Integrated Care Model (MICM) and Usual Care in Heart Failure With Preserved Ejection Fraction (HFpEF) and Heart Failure, sponsored by Chimei Medical Center. Not yet recruiting at 1 site in Taiwan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-01.
Sponsored by Chimei Medical Center · Not applicable, Interventional, and Health services research
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.
Heart failure with preserved ejection fraction (HFpEF) is a heterogeneous clinical syndrome characterized by signs and symptoms of heart failure with a left ventricular ejection fraction ≥50%. It disproportionately affects older adults and patients with multiple comorbidities, including hypertension, diabetes, obesity, and chronic kidney disease. Despite its high prevalence and disease burden, few pharmacologic therapies have demonstrated consistent benefit in this population, highlighting the importance of non-pharmacologic and system-level interventions.
This study investigates whether a Multidisciplinary Integrated Care Model (MICM) improves care outcomes for patients with HFpEF compared with historical usual care. The MICM intervention integrates the following components:
Eligible participants are adults diagnosed with HFpEF (left ventricular ejection fraction ≥50%) who receive care at the study institution. The intervention cohort will be prospectively enrolled and followed under the MICM program, while the historical control cohort will consist of patients who received standard usual care prior to program implementation, matched on relevant baseline characteristics.
Outcomes of interest include heart failure-related hospitalization and emergency visits, all-cause mortality, functional capacity, NYHA functional class, and health-related quality of life. Data will be collected through structured clinical assessments and medical record review at baseline and at scheduled follow-up intervals.
Findings from this study are intended to generate evidence on the effectiveness of multidisciplinary, team-based care models in improving outcomes for patients with HFpEF, and to inform future integrated care program development in similar clinical settings.
6,331 studies on the registry are indexed under Heart Failure; 1,396 are open to participants now.
This study's planned enrollment of 200 is above the median of 76 across 4,049 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →Chimei Medical Center is the lead sponsor of 27 studies on the registry; 6 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants prospectively enrolled and managed under the Multidisciplinary Integrated Care Model (MICM), receiving coordinated care from cardiologists, case managers, pharmacists, dietitians, and rehabilitation specialists, in addition to standard cardiology follow-up.
Other: Multidisciplinary Integrated Care Model (MICM)
A retrospective cohort of patients with heart failure with preserved ejection fraction who received usual, non-integrated cardiology care prior to implementation of the multidisciplinary integrated care model.
Other: Usual Care
A 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.
Standard, non-integrated cardiology care as routinely provided prior to implementation of the multidisciplinary integrated care model.
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.
Time frame: From hospital admission to discharge, up to 30 days
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.
Time frame: 30 days post-discharge
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.
Time frame: 90 days post-discharge
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.
Time frame: Baseline and 3 months post-intervention
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.
Time frame: Baseline and 3 months post-intervention
Plan to share: No — Individual participant data will not be shared, as this study involves data collected under local institutional review board approval, and the study protocol does not include provisions for external data sharing due to patient privacy and confidentiality considerations.
No publications or documents are linked to this record.
Start is estimated for Aug 2026; primary completion for Jul 2027, 11 months later.
Of 1,118 non-industry interventional studies with no phase under Heart Failure, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 50. This study's planned 11 months is below that.
Counting every sponsor, half of 1,354 studies reached it within 31 months; a quarter within 16 and three quarters within 52.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Chimei Medical Center