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The Effectiveness of Collaborative Health Management Model on Heart Failure Patient

A

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

Status

Enrolling

Conditions

Heart Failure With Reduced Ejection Fraction (HFrEF)

Treatments

Behavioral: collaborative health management model

Study type

Interventional

Funder types

Other

Identifiers

NCT04860596
TSMH IRB No 20-128-B

Details and patient eligibility

About

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.

Full 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.

Enrollment

120 estimated patients

Sex

All

Ages

20 to 100 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

120 participants in 2 patient groups

collaborative health management model program
Experimental group
Description:
nursing education and self care program
Treatment:
Behavioral: collaborative health management model
Routine care
No Intervention group
Description:
Tranditional education program

Trial contacts and locations

2

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Central trial contact

Chih-Wen Chen

Data sourced from clinicaltrials.gov

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