跳至主要内容
临床试验/NCT04860596
NCT04860596Unknown不适用

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

Antai Medical Care Corperation Antai Tian-Sheng Memorial Hospital/ Department of Nursing/National Ta3 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2022年8月6日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
120
试验地点
3
主要终点
CHF functional status

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
20 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 未提供

结局指标

主要结局

CHF functional status

时间窗: post intervention 3 months

NYHAClass Ⅰ\~Ⅲ

CHF quality of life

时间窗: post intervention 3 months

Minnesota living with heart failure questionnaire, MLHFQ

CHF rehospitalization

时间窗: post intervention 3 months

Re-admission rate

CHF Self care behaviour

时间窗: post intervention 3 months

Heart Failure Self-Care Behaviour Sacle, EHFScBS

CHF Depression

时间窗: post intervention 3 months

Beck Depression Inventory(BDI)

次要结局

未报告次要终点

研究者

发起方
Antai Medical Care Corperation Antai Tian-Sheng Memorial Hospital/ Department of Nursing/National Ta
申办方类型
Other
责任方
Principal Investigator
主要研究者

Chih-Wen Chen

Nurse Practitioner Leader

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

研究点 (3)

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