Heart Failure With Preserved Ejection Fraction (HFpEF)MICM-HFpEFNCT07798856
Effects of a Multidisciplinary Integrated Care Model on Care Outcomes in Patients With Heart Failure With Preserved Ejection Fraction
A study testing Multidisciplinary Integrated Care Model (MICM) in people with Heart Failure With Preserved Ejection Fraction (HFpEF) and Heart Failure, run by Chimei Medical Center at 1 site in Taiwan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure With Preserved Ejection Fraction (HFpEF), Heart Failure
- What is being tested?
- Multidisciplinary Integrated Care Model (MICM)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2026to Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Able to communicate in Mandarin or Taiwanese and understand the study intervention
- For the prospective intervention group: willing to participate and provide written informed consent. For the historical control group: existing medical record data will be collected under a waiver of informed consent.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site
Chi Mei Medical Center
Tainan, Yongkang Dist, 71004
Kai-Ning Chung, RN, MSN, +886-6-2812811 ext. 57121, 9608L7@chimei.org.tw
Kai-Ning Chung, RN, MSN
About this study
Official title: 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
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.
Read the detailed description
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:
- Cardiology-led clinical management with guideline-directed medical therapy optimization
- Case management for care coordination, symptom monitoring, and care transitions
- Pharmacist-led medication review and adherence support
- Nutritional counseling tailored to heart failure and comorbidity management
- Structured exercise and cardiac rehabilitation guidance
- Patient and caregiver education on self-management and warning signs
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.
- Being tested
- Multidisciplinary Integrated Care Model (MICM), Usual Care
- Keywords
- Multidisciplinary Care, Heart Failure Management, HFpEF
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multidisciplinary Integrated Care Model (MICM)Other
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.
Usual CareOther
Standard, non-integrated cardiology care as routinely provided prior to implementation of the multidisciplinary integrated care model.
| Study group | Role | What they receive |
|---|---|---|
| MICM Intervention Group | Experimental | 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. Receives: Other: Multidisciplinary Integrated Care Model (MICM) |
| Historical Control Group | Other | 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. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 90 days post-discharge
Secondary outcomes (2)
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.
Measured: 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.
Measured: Baseline and 3 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2026
- Study startAug 2026 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure With Preserved Ejection Fraction (HFpEF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be assigned to two arms: a prospective intervention arm receiving the multidisciplinary integrated care model, and a historical control arm consisting of patients who received usual care prior to program implementation.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chimei Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07798856
- Sponsor's protocol ID
- CMMC11506-020
- Acronym
- MICM-HFpEF
- Status last verified
- Aug 2026
- First submitted
- 9 Aug 2026
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07798856
- Acronym / sponsor ID
- MICM-HFpEF / CMMC11506-020
- Keywords
- Multidisciplinary Care, Heart Failure Management, HFpEF
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Chimei Medical CenterUniversity, hospital or other
- Study start
- Aug 2026 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 1 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- Cardiology-led clinical management with guideline-directed medical therapy optimization
- Case management for care coordination, symptom monitoring, and care transitions
- Pharmacist-led medication review and adherence support
- Nutritional counseling tailored to heart failure and comorbidity management
- Structured exercise and cardiac rehabilitation guidance
- Patient and caregiver education on self-management and warning signs
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be assigned to two arms: a prospective intervention arm receiving the multidisciplinary integrated care model, and a historical control arm consisting of patients who received usual care prior to program implementation.
| Arm | Type | Receives |
|---|---|---|
| MICM Intervention Group | Experimental | Other: Multidisciplinary Integrated Care Model (MICM)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. |
| Historical Control Group | Other | Other: Usual CareA 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
- Able to communicate in Mandarin or Taiwanese and understand the study intervention
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multidisciplinary Integrated Care Model (MICM)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. | Other | MICM Intervention Group |
| Usual CareStandard, non-integrated cardiology care as routinely provided prior to implementation of the multidisciplinary integrated care model. | Other | Historical Control Group |
Primary outcome
Length of Hospital Stay
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.
30-Day Hospital Readmission Rate
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.
90-Day Hospital Readmission Rate
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.
2 secondary outcomes
Change in Quality of Life as Measured by the Minnesota Living with Heart Failure Questionnaire (MLHFQ)
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)
Time frame: Baseline and 3 months post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multidisciplinary Integrated Care Model (MICM) in people with Heart Failure With Preserved Ejection Fraction (HFpEF) and Heart Failure, run by Chimei Medical Center at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kai-Ning Chung, RN, MSN (+886-6-+886-6-2812811 ext. 57121, 9608L7@chimei.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of Hospital Stay (time frame: From hospital admission to discharge, up to 30 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.