Chi Mei Medical Center
Tainan, Yongkang Dist, 71004, Taiwan
Location contact
Kai-Ning Chung, RN, MSN
CONTACT
+886-6-2812811 ext. 57121
Kai-Ning Chung, RN, MSN
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07798856
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Tainan, Yongkang Dist, 71004, Taiwan
Kai-Ning Chung, RN, MSN
CONTACT
+886-6-2812811 ext. 57121
Kai-Ning Chung, RN, MSN
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: From hospital admission to discharge, up to 30 days
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: 30 days post-discharge
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: 90 days post-discharge
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: Baseline and 3 months post-intervention
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 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.
Contact information is provided by the study sponsor or research team.
Chimei Medical Center
Other
A Prospective Quasi-Experimental Study With Historical Control to Evaluate the Effects of a Multidisciplinary Integrated Care Model on Care Outcomes in Patients With Heart Failure With Preserved Ejection Fraction
Acronym: MICM-HFpEF
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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