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The Effectiveness of Collaborative Health Management Model on Heart Failure Patient

Primary Purpose

Heart Failure With Reduced Ejection Fraction (HFrEF)

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
collaborative health management model
Sponsored by
Antai Medical Care Corperation Antai Tian-Sheng Memorial Hospital/ Department of Nursing/National Ta
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Heart Failure With Reduced Ejection Fraction (HFrEF)

Eligibility Criteria

20 Years - 100 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Antai Medical Care Cooperation Antai Tian-Sheng Memorial Hospital
  • Research teamRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

collaborative health management model program

Routine care

Arm Description

nursing education and self care program

Tranditional education program

Outcomes

Primary Outcome Measures

CHF functional status
NYHAClass Ⅰ~Ⅲ
CHF functional status
NYHAClass Ⅰ~Ⅲ
CHF functional status
NYHAClass Ⅰ~Ⅲ
CHF functional status
NYHAClass Ⅰ~Ⅲ
CHF quality of life
Minnesota living with heart failure questionnaire, MLHFQ
CHF quality of life
Minnesota living with heart failure questionnaire, MLHFQ
CHF quality of life
Minnesota living with heart failure questionnaire, MLHFQ
CHF quality of life
Minnesota living with heart failure questionnaire, MLHFQ
CHF rehospitalization
Re-admission rate
CHF rehospitalization
Re-admission rate
CHF rehospitalization
Re-admission rate
CHF rehospitalization
Re-admission rate
CHF Self care behaviour
Heart Failure Self-Care Behaviour Sacle, EHFScBS
CHF Self care behaviour
Heart Failure Self-Care Behaviour Sacle, EHFScBS
CHF Self care behaviour
Heart Failure Self-Care Behaviour Sacle, EHFScBS
CHF Self care behaviour
Heart Failure Self-Care Behaviour Sacle, EHFScBS
CHF Depression
Beck Depression Inventory(BDI)
CHF Depression
Beck Depression Inventory(BDI)
CHF Depression
Beck Depression Inventory(BDI)
CHF Depression
Beck Depression Inventory(BDI)

Secondary Outcome Measures

Full Information

First Posted
April 18, 2021
Last Updated
August 6, 2022
Sponsor
Antai Medical Care Corperation Antai Tian-Sheng Memorial Hospital/ Department of Nursing/National Ta
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1. Study Identification

Unique Protocol Identification Number
NCT04860596
Brief Title
The Effectiveness of Collaborative Health Management Model on Heart Failure Patient
Official Title
The Effectiveness of Collaborative Health Management Model on Heart Failure Patient Functional Status, Quality of Life, and Rehospitalization: Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 6, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Antai Medical Care Corperation Antai Tian-Sheng Memorial Hospital/ Department of Nursing/National Ta

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure With Reduced Ejection Fraction (HFrEF)

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
collaborative health management model program
Arm Type
Experimental
Arm Description
nursing education and self care program
Arm Title
Routine care
Arm Type
No Intervention
Arm Description
Tranditional education program
Intervention Type
Behavioral
Intervention Name(s)
collaborative health management model
Intervention Description
nursing education program
Primary Outcome Measure Information:
Title
CHF functional status
Description
NYHAClass Ⅰ~Ⅲ
Time Frame
pre intervenation
Title
CHF functional status
Description
NYHAClass Ⅰ~Ⅲ
Time Frame
post intervention 1 months
Title
CHF functional status
Description
NYHAClass Ⅰ~Ⅲ
Time Frame
post intervention 2 months
Title
CHF functional status
Description
NYHAClass Ⅰ~Ⅲ
Time Frame
post intervention 3 months
Title
CHF quality of life
Description
Minnesota living with heart failure questionnaire, MLHFQ
Time Frame
pre intervention
Title
CHF quality of life
Description
Minnesota living with heart failure questionnaire, MLHFQ
Time Frame
post intervention 1 months
Title
CHF quality of life
Description
Minnesota living with heart failure questionnaire, MLHFQ
Time Frame
post intervention 2 months
Title
CHF quality of life
Description
Minnesota living with heart failure questionnaire, MLHFQ
Time Frame
post intervention 3 months
Title
CHF rehospitalization
Description
Re-admission rate
Time Frame
pre intervention
Title
CHF rehospitalization
Description
Re-admission rate
Time Frame
post intervention 1 months
Title
CHF rehospitalization
Description
Re-admission rate
Time Frame
post intervention 2 months
Title
CHF rehospitalization
Description
Re-admission rate
Time Frame
post intervention 3 months
Title
CHF Self care behaviour
Description
Heart Failure Self-Care Behaviour Sacle, EHFScBS
Time Frame
pre intervention
Title
CHF Self care behaviour
Description
Heart Failure Self-Care Behaviour Sacle, EHFScBS
Time Frame
post intervention 1 months
Title
CHF Self care behaviour
Description
Heart Failure Self-Care Behaviour Sacle, EHFScBS
Time Frame
post intervention 2 months
Title
CHF Self care behaviour
Description
Heart Failure Self-Care Behaviour Sacle, EHFScBS
Time Frame
post intervention 3 months
Title
CHF Depression
Description
Beck Depression Inventory(BDI)
Time Frame
pre intervention
Title
CHF Depression
Description
Beck Depression Inventory(BDI)
Time Frame
post intervention 1 months
Title
CHF Depression
Description
Beck Depression Inventory(BDI)
Time Frame
post intervention 2 months
Title
CHF Depression
Description
Beck Depression Inventory(BDI)
Time Frame
post intervention 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chih-Wen Chen
Phone
886-8329966
Ext
3012
Email
onlylandy567@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chih-Wen Chen
Organizational Affiliation
employer
Official's Role
Study Chair
Facility Information:
Facility Name
Antai Medical Care Cooperation Antai Tian-Sheng Memorial Hospital
City
Pingtung
State/Province
Donggang Township
ZIP/Postal Code
928
Country
Taiwan
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chih Wen Chen
Phone
886-8-8329966
Ext
3012
Email
onlylandy567@gmail.com
First Name & Middle Initial & Last Name & Degree
Chih Wen Chen
Facility Name
Research team
City
Pingtung
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ChihWen Chen
Phone
886-8329966
Ext
3012
Email
onlylandy567@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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The Effectiveness of Collaborative Health Management Model on Heart Failure Patient

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