The Effectiveness of Collaborative Health Management Model on Heart Failure Patient

NCT ID: NCT04860596

Last Updated: 2022-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-06

Study Completion Date

2023-12-31

Brief Summary

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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

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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.

Conditions

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Heart Failure With Reduced Ejection Fraction (HFrEF)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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collaborative health management model program

nursing education and self care program

Group Type EXPERIMENTAL

collaborative health management model

Intervention Type BEHAVIORAL

nursing education program

Routine care

Tranditional education program

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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collaborative health management model

nursing education program

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* NIL
Minimum Eligible Age

20 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Antai Medical Care Corperation Antai Tian-Sheng Memorial Hospital/ Department of Nursing/National Ta

OTHER

Sponsor Role lead

Responsible Party

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Chih-Wen Chen

Nurse Practitioner Leader

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chih-Wen Chen

Role: STUDY_CHAIR

employer

Locations

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Antai Medical Care Cooperation Antai Tian-Sheng Memorial Hospital

Pingtung City, Donggang Township, Taiwan

Site Status NOT_YET_RECRUITING

Research team

Pingtung City, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Chih-Wen Chen

Role: CONTACT

886-8329966 ext. 3012

Facility Contacts

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Chih Wen Chen

Role: primary

886-8-8329966 ext. 3012

ChihWen Chen

Role: primary

886-8329966 ext. 3012

References

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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.

Reference Type DERIVED
PMID: 39709786 (View on PubMed)

Other Identifiers

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TSMH IRB No 20-128-B

Identifier Type: -

Identifier Source: org_study_id

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