Heart Failure With Reduced Ejection Fraction (HFrEF)NCT04860596
The Effectiveness of Collaborative Health Management Model on Heart Failure Patient
A study testing collaborative health management model in people with Heart Failure With Reduced Ejection Fraction (HFrEF), run by Antai Medical Care Corperation Antai Tian-Sheng Memorial Hospital/ Department of Nursing/National Ta at 2 sites in Taiwan.
Trial summary
The purpose of this study is to explore the effect of the collaborative health management model on the functional status, quality of life and rehospitalization rate of patients with heart failure. This is a three-year project. Read more about this study
- Who is it for?
- Ages 20 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Failure With Reduced Ejection Fraction (HFrEF)
- What is being tested?
- collaborative health management model
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesTaiwan
- Study dates
- 6 Aug 2022to Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ⑴Patients diagnosed as heart failure by specialists (NYHA Ⅰ-III); ⑵20 years of age or older; ⑶Patients with clear consciousness and no cognitive impairment and major diseases (such as cancer); ⑷Can communicate in Mandarin and Taiwanese; ⑸ Those who can answer the questionnaire by themselves or with the assistance of a research assistant.
Who cannot join
- NIL
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites, 2 recruiting
- Not yet recruiting
Antai Medical Care Cooperation Antai Tian-Sheng Memorial Hospital
Pingtung City, Donggang Township, 928
Chih Wen Chen, 886-8-8329966 ext. 3012, onlylandy567@gmail.com
Chih Wen Chen
- Recruiting
Research team
Pingtung City
ChihWen Chen, 886-8329966 ext. 3012, onlylandy567@gmail.com
About this study
Official title: The Effectiveness of Collaborative Health Management Model on Heart Failure Patient Functional Status, Quality of Life, and Rehospitalization: Randomized Controlled Trial
The purpose of this study is to explore the effect of the collaborative health management model on the functional status, quality of life and rehospitalization rate of patients with heart failure. This is a three-year project. The first phase (introduction phase): A systematic literature review and meta-analysis of collaborative care and heart failure patients will be conducted, and relevant research results will be evaluated for the clinical benefits of heart failure patients, and empirical knowledge will be proposed as The basic holistic conclusions are supported by the research literature on the establishment of a collaborative health management model for heart failure (CHMM). The second stage (construction period): based on the results of systematic literature review and meta-analysis, adopt the CHMM model, design intervention measures, and conduct pilot studies to determine the safety and feasibility of the research, and review future research improvements Wherever possible, develop more complete intervention measures. The third stage (operation period): Randomized controlled trials were adopted, with random sampling and double-blind research design. In the cardiology ward of a regional teaching hospital in the south, 120 patients with heart failure who met the admission criteria were selected, and 60 patients were selected as control group. The group received routine care in the hospital, and 60 of the experimental group received interventions in the collaborative health management model. Data collection includes variables such as physiological indices, functional status, self-care behavior, quality of life, re-admission rate, medical cost. Instruments tools include Minnesota Heart Failure Quality of Life Questionnaire, European Heart Failure Self-care Behavior Scale after the intervention 1 month, 2 months, and 3 months.The intervention effect will be statistically verified and analyzed by GEE. It is hoped that this care model will be applied to the clinical care of patients with heart failure, and will be verified by clinical benefits, reduce symptom troubles, improve quality of life, and reduce medical costs.
Read the detailed description
The purpose of this study is to explore the effect of the collaborative health management model on the functional status, self care, depression, quality of life and rehospitalization rate of patients with heart failure. This is a three-year project. The first phase (introduction phase): A systematic literature review and meta-analysis of collaborative care and heart failure patients will be conducted, and relevant research results will be evaluated for the clinical benefits of heart failure patients, and empirical knowledge will be proposed as The basic holistic conclusions are supported by the research literature on the establishment of a collaborative health management model for heart failure (CHMM). The second stage (construction period): based on the results of systematic literature review and meta-analysis, adopt the CHMM model, design intervention measures, and conduct pilot studies to determine the safety and feasibility of the research, and review future research improvements Wherever possible, develop more complete intervention measures. The third stage (operation period): Randomized controlled trials were adopted, with random sampling and double-blind research design. In the cardiology ward of a regional teaching hospital in the south, 120 patients with heart failure who met the admission criteria were selected, and 60 patients were selected as control group. The group received routine care in the hospital, and 60 of the experimental group received interventions in the collaborative health management model, including identifying high-risk patients and tracking them by electronic medical records, inter-disciplinary team members discussing patient issues, setting goals together, and passing cross-team members Jointly provide professional care, post-discharge outpatient and telephone follow-up case self-monitoring status, provide telephone consultation hotline, Data collection includes variables such as functional status, self-care behavior, depression, quality of life, re-admission rate. Instruments tools include European Heart Failure Self-care Behavior Scale, Beck Depression Inventory, Minnesota Heart Failure Quality of Life Questionnaire, after the intervention 1 month, 2 months, and 3 months.The intervention effect will be statistically verified and analyzed by GEE. It is hoped that this care model will be applied to the clinical care of patients with heart failure, and will be verified by clinical benefits, reduce symptom troubles, improve quality of life, and reduce medical costs.
- Being tested
- collaborative health management model
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
collaborative health management modelBehavioural
nursing education program
| Study group | Role | What they receive |
|---|---|---|
| collaborative health management model program | Experimental | nursing education and self care program Receives: Behavioral: collaborative health management model |
| Routine care | No intervention | Tranditional education program |
What is being measured
The primary outcome is the main question the study is designed to answer.
CHF functional status
NYHAClass Ⅰ~Ⅲ
Measured: pre intervenation
CHF functional status
NYHAClass Ⅰ~Ⅲ
Measured: post intervention 1 months
CHF functional status
NYHAClass Ⅰ~Ⅲ
Measured: post intervention 2 months
CHF functional status
NYHAClass Ⅰ~Ⅲ
Measured: post intervention 3 months
CHF quality of life
Minnesota living with heart failure questionnaire, MLHFQ
Measured: pre intervention
CHF quality of life
Minnesota living with heart failure questionnaire, MLHFQ
Measured: post intervention 1 months
CHF quality of life
Minnesota living with heart failure questionnaire, MLHFQ
Measured: post intervention 2 months
CHF quality of life
Minnesota living with heart failure questionnaire, MLHFQ
Measured: post intervention 3 months
CHF rehospitalization
Re-admission rate
Measured: pre intervention
CHF rehospitalization
Re-admission rate
Measured: post intervention 1 months
CHF rehospitalization
Re-admission rate
Measured: post intervention 2 months
CHF rehospitalization
Re-admission rate
Measured: post intervention 3 months
CHF Self care behaviour
Heart Failure Self-Care Behaviour Sacle, EHFScBS
Measured: pre intervention
CHF Self care behaviour
Heart Failure Self-Care Behaviour Sacle, EHFScBS
Measured: post intervention 1 months
CHF Self care behaviour
Heart Failure Self-Care Behaviour Sacle, EHFScBS
Measured: post intervention 2 months
CHF Self care behaviour
Heart Failure Self-Care Behaviour Sacle, EHFScBS
Measured: post intervention 3 months
CHF Depression
Beck Depression Inventory(BDI)
Measured: pre intervention
CHF Depression
Beck Depression Inventory(BDI)
Measured: post intervention 1 months
CHF Depression
Beck Depression Inventory(BDI)
Measured: post intervention 2 months
CHF Depression
Beck Depression Inventory(BDI)
Measured: post intervention 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2021
- Study start6 Aug 2022
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart Failure With Reduced Ejection Fraction (HFrEF)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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Antai Medical Care Corperation Antai Tian-Sheng Memorial Hospital/ Department of Nursing/National Ta
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chih-Wen Chen, Antai Medical Care Corperation Antai Tian-Sheng Memorial Hospital/ Department of Nursing/National Ta
- Investigators
- Chih-Wen Chen, Study chair, employer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04860596
- Sponsor's protocol ID
- TSMH IRB No 20-128-B
- Status last verified
- Aug 2022
- First submitted
- 18 Apr 2021
- Last updated
- 9 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Chen CW, Wang TJ, Liu CY, Chuang YH, Su CC, Wu SV. Effectiveness of a nurse practitioner-led collaborative health care model on self-care, functional status, rehospitalization and medical costs in heart failure patients: A randomized controlled trial. Int J Nurs Stud. 2025 Feb;162:104980. doi: 10.1016/j.ijnurstu.2024.104980. Epub 2024 Dec 19.
PubMed 39709786
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Collaborative Health Management Model on Heart Failure Patient Functional Status, Quality of Life, and Rehospitalization: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04860596
- Acronym / sponsor ID
- TSMH IRB No 20-128-B
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Antai Medical Care Corperation Antai Tian-Sheng Memorial Hospital/ Department of Nursing/National TaUniversity, hospital or other
- Study start
- 6 Aug 2022 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 27 Apr 2021 (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.
The purpose of this study is to explore the effect of the collaborative health management model on the functional status, quality of life and rehospitalization rate of patients with heart failure. This is a three-year project. The first phase (introduction phase): A systematic literature review and meta-analysis of collaborative care and heart failure patients will be conducted, and relevant research results will be evaluated for the clinical benefits of heart failure patients, and empirical knowledge will be proposed as The basic holistic conclusions are supported by the research literature on the establishment of a collaborative health management model for heart failure (CHMM). The second stage (construction period): based on the results of systematic literature review and meta-analysis, adopt the CHMM model, design intervention measures, and conduct pilot studies to determine the safety and feasibility of the research, and review future research improvements Wherever possible, develop more complete intervention measures. The third stage (operation period): Randomized controlled trials were adopted, with random sampling and double-blind research design. In the cardiology ward of a regional teaching hospital in the south, 120 patients with heart failure who met the admission criteria were selected, and 60 patients were selected as control group. The group received routine care in the hospital, and 60 of the experimental group received interventions in the collaborative health management model. Data collection includes variables such as physiological indices, functional status, self-care behavior, quality of life, re-admission rate, medical cost. Instruments tools include Minnesota Heart Failure Quality of Life Questionnaire, European Heart Failure Self-care Behavior Scale after the intervention 1 month, 2 months, and 3 months.The intervention effect will be statistically verified and analyzed by GEE. It is hoped that this care model will be applied to the clinical care of patients with heart failure, and will be verified by clinical benefits, reduce symptom troubles, improve quality of life, and reduce medical costs.
Detailed description
The purpose of this study is to explore the effect of the collaborative health management model on the functional status, self care, depression, quality of life and rehospitalization rate of patients with heart failure. This is a three-year project. The first phase (introduction phase): A systematic literature review and meta-analysis of collaborative care and heart failure patients will be conducted, and relevant research results will be evaluated for the clinical benefits of heart failure patients, and empirical knowledge will be proposed as The basic holistic conclusions are supported by the research literature on the establishment of a collaborative health management model for heart failure (CHMM). The second stage (construction period): based on the results of systematic literature review and meta-analysis, adopt the CHMM model, design intervention measures, and conduct pilot studies to determine the safety and feasibility of the research, and review future research improvements Wherever possible, develop more complete intervention measures. The third stage (operation period): Randomized controlled trials were adopted, with random sampling and double-blind research design. In the cardiology ward of a regional teaching hospital in the south, 120 patients with heart failure who met the admission criteria were selected, and 60 patients were selected as control group. The group received routine care in the hospital, and 60 of the experimental group received interventions in the collaborative health management model, including identifying high-risk patients and tracking them by electronic medical records, inter-disciplinary team members discussing patient issues, setting goals together, and passing cross-team members Jointly provide professional care, post-discharge outpatient and telephone follow-up case self-monitoring status, provide telephone consultation hotline, Data collection includes variables such as functional status, self-care behavior, depression, quality of life, re-admission rate. Instruments tools include European Heart Failure Self-care Behavior Scale, Beck Depression Inventory, Minnesota Heart Failure Quality of Life Questionnaire, after the intervention 1 month, 2 months, and 3 months.The intervention effect will be statistically verified and analyzed by GEE. It is hoped that this care model will be applied to the clinical care of patients with heart failure, and will be verified by clinical benefits, reduce symptom troubles, improve quality of life, and reduce medical costs.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| collaborative health management model program | Experimental | Behavioral: collaborative health management modelnursing education and self care program |
| Routine care | No intervention | –Tranditional education program |
Who may qualify
- Ages
- 20 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ⑴Patients diagnosed as heart failure by specialists (NYHA Ⅰ-III); ⑵20 years of age or older; ⑶Patients with clear consciousness and no cognitive impairment and major diseases (such as cancer); ⑷Can communicate in Mandarin and Taiwanese; ⑸ Those who can answer the questionnaire by themselves or with the assistance of a research assistant.
Key exclusion criteria (1 listed)
- NIL
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 |
|---|---|---|
| collaborative health management modelnursing education program | Behavioural | collaborative health management model program |
Primary outcome
CHF functional status
Time frame: pre intervenation
NYHAClass Ⅰ~Ⅲ
CHF functional status
Time frame: post intervention 1 months
NYHAClass Ⅰ~Ⅲ
CHF functional status
Time frame: post intervention 2 months
NYHAClass Ⅰ~Ⅲ
CHF functional status
Time frame: post intervention 3 months
NYHAClass Ⅰ~Ⅲ
CHF quality of life
Time frame: pre intervention
Minnesota living with heart failure questionnaire, MLHFQ
CHF quality of life
Time frame: post intervention 1 months
Minnesota living with heart failure questionnaire, MLHFQ
CHF quality of life
Time frame: post intervention 2 months
Minnesota living with heart failure questionnaire, MLHFQ
CHF quality of life
Time frame: post intervention 3 months
Minnesota living with heart failure questionnaire, MLHFQ
CHF rehospitalization
Time frame: pre intervention
Re-admission rate
CHF rehospitalization
Time frame: post intervention 1 months
Re-admission rate
CHF rehospitalization
Time frame: post intervention 2 months
Re-admission rate
CHF rehospitalization
Time frame: post intervention 3 months
Re-admission rate
CHF Self care behaviour
Time frame: pre intervention
Heart Failure Self-Care Behaviour Sacle, EHFScBS
CHF Self care behaviour
Time frame: post intervention 1 months
Heart Failure Self-Care Behaviour Sacle, EHFScBS
CHF Self care behaviour
Time frame: post intervention 2 months
Heart Failure Self-Care Behaviour Sacle, EHFScBS
CHF Self care behaviour
Time frame: post intervention 3 months
Heart Failure Self-Care Behaviour Sacle, EHFScBS
CHF Depression
Time frame: pre intervention
Beck Depression Inventory(BDI)
CHF Depression
Time frame: post intervention 1 months
Beck Depression Inventory(BDI)
CHF Depression
Time frame: post intervention 2 months
Beck Depression Inventory(BDI)
CHF Depression
Time frame: post intervention 3 months
Beck Depression Inventory(BDI)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2022.
- Derived from this study: PubMed 39709786Chen CW, Wang TJ, Liu CY, Chuang YH, Su CC, Wu SV. Effectiveness of a nurse practitioner-led collaborative health care model on self-care, functional status, rehospitalization and medical costs in heart failure patients: A randomized controlled trial. Int J Nurs Stud. 2025 Feb;162:104980. doi: 10.1016/j.ijnurstu.2024.104980. Epub 2024 Dec 19.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Chih-Wen Chen study chair
employer
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing collaborative health management model in people with Heart Failure With Reduced Ejection Fraction (HFrEF), run by Antai Medical Care Corperation Antai Tian-Sheng Memorial Hospital/ Department of Nursing/National Ta at 2 sites 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 9 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chih-Wen Chen (886-8329966 ext. 3012, onlylandy567@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CHF functional status (time frame: pre intervenation). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04860596, which also lists 1 linked publication.
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 9 Aug 2022.