The Effectiveness of Collaborative Health Management Model on Heart Failure Patient

August 6, 2022 updated by: Chih-Wen Chen, Antai Medical Care Corperation Antai Tian-Sheng Memorial Hospital/ Department of Nursing/National Ta

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Pingtung, Taiwan
    • Donggang Township
      • Pingtung, Donggang Township, Taiwan, 928
        • Not yet recruiting
        • Antai Medical Care Cooperation Antai Tian-Sheng Memorial Hospital
        • Contact:
        • Principal Investigator:
          • Chih Wen Chen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: collaborative health management model program
nursing education and self care program
Behavioral: collaborative health management model
nursing education program
No Intervention: Routine care
Tranditional education program

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Investigators

  • Study Chair: Chih-Wen Chen, employer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 6, 2022

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

April 18, 2021

First Submitted That Met QC Criteria

April 22, 2021

First Posted (Actual)

April 27, 2021

Study Record Updates

Last Update Posted (Actual)

August 9, 2022

Last Update Submitted That Met QC Criteria

August 6, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TSMH IRB No 20-128-B

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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