Clinical trial NCT04860596: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Failure With Reduced Ejection Fraction (HFrEF)
Lead sponsor: Antai Medical Care Corperation Antai Tian-Sheng Memorial Hospital/ Department of Nursing/National Ta
Sponsor class: OTHER
First posted: 2021-04-27
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: CHF functional status
timeFrame: pre intervenation
measure: CHF functional status
timeFrame: post intervention 1 months
measure: CHF functional status
timeFrame: post intervention 2 months
measure: CHF functional status
timeFrame: post intervention 3 months
measure: CHF quality of life
timeFrame: pre intervention
measure: CHF quality of life
timeFrame: post intervention 1 months
measure: CHF quality of life
timeFrame: post intervention 2 months
measure: CHF quality of life
timeFrame: post intervention 3 months
measure: CHF rehospitalization
timeFrame: pre intervention
measure: CHF rehospitalization
timeFrame: post intervention 1 months
measure: CHF rehospitalization
timeFrame: post intervention 2 months
measure: CHF rehospitalization
timeFrame: post intervention 3 months
measure: CHF Self care behaviour
timeFrame: pre intervention
measure: CHF Self care behaviour
timeFrame: post intervention 1 months
measure: CHF Self care behaviour
timeFrame: post intervention 2 months
measure: CHF Self care behaviour
timeFrame: post intervention 3 months
measure: CHF Depression
timeFrame: pre intervention
measure: CHF Depression
timeFrame: post intervention 1 months
measure: CHF Depression
timeFrame: post intervention 2 months
measure: CHF Depression
timeFrame: post intervention 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Pingtung
country: Taiwan
facility: Antai Medical Care Cooperation Antai Tian-Sheng Memorial Hospital
state: Donggang Township
city: Pingtung
country: Taiwan
facility: Research team
Study officials:
affiliation: employer
name: Chih-Wen Chen
role: STUDY_CHAIR
References: