跳至主要内容
临床试验/NCT06161649
NCT06161649招募中不适用

To Investigate Whether a Continuous Intelligent and Automated Mobile Education System Can Improve Knowledge, Self-care, Emotional Stress, Self-efficacy and Quality of Life in Patients With Heart Failure

Chang Gung Memorial Hospital1 个研究点 分布在 1 个国家目标入组 138 人开始时间: 2023年11月21日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
138
试验地点
1
主要终点
Heart Failure knowledge scale

研究概览

简要总结

Heart failure (HF) is an incurable and complex disease syndrome with sophisticated disease trajectories. The guideline for HF management suggests that treatment should include adequate education to help patients have better self-management ability, and improve their quality of life and prognosis. However, how to provide massive amount of HF patients a continuous, complete and individualized disease care education from hospitalization, post-discharge, to home for months is a difficult problem. This study plans to develop an automated and intelligent education system for HF on the mobile device "Line" platform. Through this platform, we hope to make the HF education continuous for 3 months from hospital to post-discharge period. We hypothesize that (1) this intervention can improve knowledge, self-care, emotional stress, self-efficacy, quality of life and disease outcomes in patients of HF; (2) the system developed in this study can reduce the hours of nursing work while improve the quality of education and become the best clinical auxiliary education tool.

详细描述

Study background

Heart failure is a complex disease syndrome, and patients often suffer from multiple chronic diseases. Faced with the problem of disease symptoms, if patients do not have sufficient care knowledge, patients often mistakenly think that it is related to aging, and may even delay medical treatment, resulting in the need for hospitalization when it worsens. Emergency treatment may even deal with respiratory failure in severe cases. Such repeated hospitalizations will affect the quality of life and lead to poor disease prognosis for patients. Heart failure treatment guidelines have recommended that in addition to the use of standard drugs for disease treatment, systematic and structured disease education should be provided continuously during hospitalization and after discharge to help patients effectively implement disease self-management and improve the quality of disease care, quality of life and life satisfaction. Interventional studies and comprehensive literature review data have also confirmed that disease education provided by nursing staff can significantly improve the knowledge, behavior, self-efficacy, quality of life, and reduce re-hospitalization of heart failure patients. Due to the high fluctuations in the course of heart failure and the interlocking influence of multiple comorbidities, disease care information should be provided not only during hospitalization, but also during the period of discharge and at home after the acute phase. Facing complex and ever-changing disease troubles often lead to overwhelming anxiety and negative emotional stress. For heart failure patients, it is necessary to provide individualized and continuous disease care information from hospitalization, discharge to home during the chronic stage of the disease. Educational navigation helps patients have good self-efficacy to perform self-disease management at home, and then learn to coexist with the disease and obtain a better quality of life with the disease.

In recent years, during the epidemic of Coronavirus disease 2019 (COVID-19), in order to prevent the spread of the virus, disease prevention and control organizations have recommended care and management strategies for chronic diseases through remote and other mobile health care Internet platforms. Care services should be provided to maintain the continuity of nursing education in the case of zero contact. In a survey study, it was found that information sharing through social networks during the epidemic was positively helpful for patients' self-care. It can be seen that it is acceptable to use portable mobile phones for educational interaction on heart failure. Unfortunately, most of the current applications still monitor patients' physiological parameters such as blood pressure, pulse, weight, heart rhythm and other data. Mobile devices are mainly used to predict disease risk, and the provision of care information mainly uses SMS notifications to remind return visits, or simple data responses based on the results of physiological parameters. However, these require long-term measurement data to generate feedback. Since learning is a kind of interpersonal interaction, when providing disease information, if text is simply sent through text messages, patients with insufficient knowledge and literacy may not be able to identify the key points that really need to be learned. In addition, it is fixed and not personalized. The education system cannot produce substantial effects.

In the ever-changing medical environment of the epidemic, how to enable heart failure patients to continue to receive complete disease care education from hospitalization, discharge to home is a difficult problem. Because investigators have spent two years in the past working to develop an APP software platform. This platform has an automated import system, a combination of personalized educational video software, video-specific examination questions, and learning evaluation. It measures the function of the mechanism, but it still lacks intelligent performance. In addition, our heart failure center has 15 years of clinical care resources and has completed hundreds of educational videos and a tracking database of long-term patient phone interviews. Investigators hope to use cluster analysis to classify the original data. In order to explore the needs of patients at different times and achieve intelligent docking of needs and educational videos, investigators plan to develop an automated and intelligent educational assistance system for heart failure on the mobile device "Line" platform, hoping to use the assistance system in mobile devices. The intervention continues to extend heart failure disease education from the hospital to the home follow-up period, so that patients can have a sufficient disease learning process, acquire effective self-care abilities, and thereby improve their quality of life. It is also hoped that the system developed through this research can help nursing staff meet the different care needs of patients in different disease stages despite busy clinical work. Make education personal and continuous, and reduce the number of nursing work hours while still maintaining educational quality, becoming the best clinical auxiliary tool that can be replicated in education on various diseases.

The main themes of the study

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

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

入选标准

  • Patients with a diagnosis of heart failure
  • Patients with age >= 20 years old
  • patients with clear consciousness
  • Patients who can communicate with by Chinese or Taiwanese, and are willing to participate this study

排除标准

  • patients who are long-term bedridden, or living dependent of others
  • patients who have severe psychological disease, or severe cognitive dysfunction
  • patients without utilizing smartphone or internet

结局指标

主要结局

Heart Failure knowledge scale

时间窗: 6 month

The HF knowledge scale has 15 questions, self-administered questionnaire that covers items concerning HF knowledge in general, knowledge on HF treatment (including diet and fluid restriction) and HF symptoms and symptom recognition. For each item, patients can choose from three options, with one of the options being the correct answer. The scale has a minimum score of 0 (no knowledge) and a maximum score of 15 points (optimal knowledge).

Composite events of one-year Re-Hospitalization and all-cause death

时间窗: 1 year

Follow-up begins after enroll. Follow-up data are prospectively obtained every month from hospital records, personal communication with patients' physicians, telephone interviews, and records of regular visits to staff physicians' outpatient clinics. All-cause death is chosen as an endpoint because of the inter- relationship of heart failure with many other comorbidities in the patient cohort. Re-hospitalization is defined as a re-hospitalization due to worsening heart failure. In the statistical analysis for outcomes, composite events combining heart failure-related re-hospitalization and all-cause death will be estimated. Based on these two different endpoints, time to the first event was analyzed.

Hospital anxiety and depression scale (HADS)

时间窗: 6 month

The hospital anxiety and depression scale has 14 items. Seven of the items indicate anxiety and the remaining seven items indicate depression. The answer format offers four response options, which are scored with values ranging from 0 to 3. This results in scale values between 0 and 21 for each scale. The original test authors defined three ranges for both of the scales: 0-7 (non-cases), 8-10 (doubtful cases), and 11-21(cases).

Cardiac Self efficacy questionnaire

时间窗: 6 month

The core self-evaluations scale has 13 questions. A 5-point Likert scale was used, ranging from 1 (not at all confident) to 5 (very confident), a higher score indicates higher cardiac self-efficacy. Each question asks the patient to rate their level of confidence that using a five-point Likert scale. A score of 1 indicates "not at all", 2 "somewhat confident", 3 "moderately confident", 4 "very confident", and 5 "completely confident". The cardiac self-efficacy questionnaire has 13 items and the total score range is 0 to 65 points, with higher scores indicating greater self-efficacy.

Minnesota Living With Heart Failure questionnaire

时间窗: 6 month

The MLHF questionnaire is a disease-specific questionnaire designed to measure quality of life in patients with heart failure. This questionnaire is scored using a 5-point Likert scale and includes two subscales that address the physical and emotional domains, respectively. The questionnaire aims to reveal how patients feel about the changes in life caused by heart failure and symptom treatment during the past 1-month period. Each of the 21 questions in the questionnaire is scored from 0 to 5, with the total score range for the MLHF ranging from 0 to 105. Higher scores correlate with poorer quality of life.

Service satisfaction scale

时间窗: 6 month

The service satisfaction scale was developed by the researcher to understand the subjects' satisfaction with the use of the automated mobile education system or traditional outpatient care. It has 10 questions in total.

Self-Care of Heart Failure Index (SCHFI)

时间窗: 6 month

SCHFI Version 6.2 has 22 items rated on a 4-point response scale, and divided into the following three scales: self-care maintenance, self-care management, and self-care confidence. The total score for each separate scale is standardized from zero to 100. Higher scores indicating higher contribution to self-care.

次要结局

未报告次要终点

研究者

发起方
Chang Gung Memorial Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

MIN-HUI LIU

Heart Failure Center

Chang Gung Memorial Hospital

研究点 (1)

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