The Effectiveness of Collaborative Health Management Model on Heart Failure Patient

Heart Failure With Reduced Ejection Fraction (HFrEF) Clinical Trial

Official title:

The Effectiveness of Collaborative Health Management Model on Heart Failure Patient Functional Status, Quality of Life, and Rehospitalization: Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04860596
• Other study ID #: TSMH IRB No 20-128-B
• Status: Recruiting
• Phase: N/A
• Start date: August 6, 2022
• Est. completion date: December 2023

Study information

• Verified date: August 2022
• Source: Antai Medical Care Corperation Antai Tian-Sheng Memorial Hospital/ Department of Nursing/National Ta
• Contact: Chih-Wen Chen
• Phone: 886-8329966
• Email: onlylandy567[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 100 Years

Eligibility

Inclusion Criteria:

• ?Patients diagnosed as heart failure by specialists (NYHA ?-III); ?20 years of age or older; ?Patients with clear consciousness and no cognitive impairment and major diseases (such as cancer); ?Can communicate in Mandarin and Taiwanese; ? Those who can answer the questionnaire by themselves or with the assistance of a research assistant.

Exclusion Criteria:

• NIL

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure With Reduced Ejection Fraction (HFrEF)

Intervention

Behavioral:
• collaborative health management model
nursing education program

Locations

Country	Name	City	State
Taiwan	Antai Medical Care Cooperation Antai Tian-Sheng Memorial Hospital	Pingtung	Donggang Township
Taiwan	Research team	Pingtung

Sponsors (1)

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

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CHF functional status	NYHAClass ?~?	pre intervenation
Primary	CHF functional status	NYHAClass ?~?	post intervention 1 months
Primary	CHF functional status	NYHAClass ?~?	post intervention 2 months
Primary	CHF functional status	NYHAClass ?~?	post intervention 3 months
Primary	CHF quality of life	Minnesota living with heart failure questionnaire, MLHFQ	pre intervention
Primary	CHF quality of life	Minnesota living with heart failure questionnaire, MLHFQ	post intervention 1 months
Primary	CHF quality of life	Minnesota living with heart failure questionnaire, MLHFQ	post intervention 2 months
Primary	CHF quality of life	Minnesota living with heart failure questionnaire, MLHFQ	post intervention 3 months
Primary	CHF rehospitalization	Re-admission rate	pre intervention
Primary	CHF rehospitalization	Re-admission rate	post intervention 1 months
Primary	CHF rehospitalization	Re-admission rate	post intervention 2 months
Primary	CHF rehospitalization	Re-admission rate	post intervention 3 months
Primary	CHF Self care behaviour	Heart Failure Self-Care Behaviour Sacle, EHFScBS	pre intervention
Primary	CHF Self care behaviour	Heart Failure Self-Care Behaviour Sacle, EHFScBS	post intervention 1 months
Primary	CHF Self care behaviour	Heart Failure Self-Care Behaviour Sacle, EHFScBS	post intervention 2 months
Primary	CHF Self care behaviour	Heart Failure Self-Care Behaviour Sacle, EHFScBS	post intervention 3 months
Primary	CHF Depression	Beck Depression Inventory(BDI)	pre intervention
Primary	CHF Depression	Beck Depression Inventory(BDI)	post intervention 1 months
Primary	CHF Depression	Beck Depression Inventory(BDI)	post intervention 2 months
Primary	CHF Depression	Beck Depression Inventory(BDI)	post intervention 3 months