Clinical trial NCT06161649: Mobile Education System to Improve Disease Knowledge, Self-efficacy and Quality of Life in Patients With Heart Failure
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Decompensated Heart Failure
Keywords: Heart failure
automation
smart mobile education system
disease knowledge
self-care
emotional stress
self-efficacy
quality of life
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2023-12-08
Enrollment: 138
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: 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

1. Exploring the disease care information that heart failure patients need at different disease stages
2. Establish a continuous automated intelligent mobile education system for heart failure.
3. Participate and explore the effect of the use of continuous automated intelligent mobile education system on disease knowledge and self-care behavior of heart failure patients.
4. To explore the impact of the use of continuous automated intelligent mobile education system on anxiety and depression in patients with heart failure.
5. To explore the effectiveness of the use of continuous automated intelligent mobile education system on the self-efficacy of heart failure patients.
6. To explore the effectiveness of the use of continuous automated intelligent mobile education system on the quality of life of patients with heart failure.
7. To explore the effect of the use of continuous automated intelligent mobile education system on the six-month to one-year disease prognosis of heart failure patients.

Study Methods

According to the purpose of the research, this research plan uses a randomized controlled intervention research design method to implement and complete the research plan over a three-year period. The following is a description of the progress of the research plan in each year:

Research design Research plan This study adopts a randomized two-group pre-test and post-test experimental design to compare the effectiveness of using an automated intelligent educational software system on the self-efficacy and quality of life of patients with heart failure.

Research objects and places The first stage of this research is to complete the continuous automated intelligent mobile education system (first year). The research subjects in the second and third years of this study are selected through purposive sampling, and the subjects are patients diagnosed with heart failure in a regional teaching hospital or outpatient clinic in the north Taiwan. The conditions for inclusion and exclusion of research subjects are described in another section.

Number of samples in the second to third years In this study, participants are divided into intervention groups and control groups, and each receives five questionnaires. The estimated sample number is set with an α value of .05 and a power of .8. It is estimated that the intervention group and the control group will receive 57 cases each, totaling 114 people. It is considered that there will be a 20% attrition rate during the follow-up intervention period. Thus, the estimated sample size is 138 people.

Study tools

1. First year:

   The reliability and validity evaluation method of the educational videos in the system adopts the "Education System" developed by the Agency for Healthcare Research and Quality (AHRQ). The Patient Education Materials Assessment Tool (PEMAT) evaluates the understandability and feasibility of educational videos. This tool has two aspects, namely understandability and feasibility.
2. Two to three years:

The second phase of this study is mainly to test the effectiveness of the continuous automated intelligent mobile education system intervention program on the disease knowledge, emotional stress, self-efficacy and quality of life of heart failure patients. Structured questionnaires are adopted, including a total of six questionnaires, namely basic personal information questionnaire, heart failure knowledge scale, heart failure self-care scale, hospital anxiety and depression scale, self-efficacy scale, and quality of life scale and service satisfaction scale, as listed up below.

Intervention measures (second to third years) Introduction to the continuous automated intelligent education system: This system is developed by Liu Min Hui and Professor Wang Chao-Hung from Keelung Chang Gung Memorial Heart Failure Center.

The description of the confidentiality methods, information security measures, and database storage and management measures for network information security subjects is as follows:

1. Confidentiality of Subject Information
2. Cloud data backup
3. Information security measures
4. Database storage and management measures
5. Intellectual property rights in producing health education multimedia to protect medical staff
6. Functional interface of this automated intelligent education software system

Research steps The subjects are randomly assigned to the intervention group (receiving the automated intelligent education software system) and the control group (receiving the original medical care method), and the disease prognosis of the two groups is tracked six to twelve months after discharge (re- hospitalizations and deaths).

The following is a description of the admission and care process for the intervention group and the control groups:

1. Intervention group (accepting the operation process of automated intelligent education software system):

1. Execute registration and qualification review
2. Automated smart education interaction At the same time, the patient will receive a personal disease self-care education manual, and will get the contact number of the case manager in case the patients encounter emergencies or disease care needs at home (the patient can call for consultation on home care for diseases if the patient want).

2. Control group: After confirming that the diagnosis of heart failure is met, the patient will receive 10-15 minutes of disease care education from a nurse when the patient receives the case. At the same time, the patient will receive a personal disease self-care education manual, and will get the contact number of the case manager in case the patients encounter emergencies or disease care needs at home (the patient can call for consultation on home care for diseases if the patient want).

Data analysis Data are collected at 5 time points starting from enroll to 6 months. For assessment, a few questionnaires are used, including Heart Failure knowledge scale, self-care of heart failure index, hospital anxiety and depression scale, self-efficacy scale, quality of life scale and satisfaction scale. Data analysis is performed with SPSS 22.0 software. Statistical analysis includes descriptive statistics, cluster analysis, independent samples t-test, single factor Analysis of variance one-way ANOVA, and generalized estimating equations (generalized estimating equations, GEE).

Eligibility criteria: Inclusion Criteria：

* 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

Exclusion Criteria：

* 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

Primary outcomes:
measure: Composite events of one-year Re-Hospitalization and all-cause death
timeFrame: 1 year
measure: Heart Failure knowledge scale
timeFrame: 6 month
measure: Self-Care of Heart Failure Index (SCHFI)
timeFrame: 6 month
measure: Hospital anxiety and depression scale (HADS)
timeFrame: 6 month
measure: Cardiac Self efficacy questionnaire
timeFrame: 6 month
measure: Minnesota Living With Heart Failure questionnaire
timeFrame: 6 month
measure: Service satisfaction scale
timeFrame: 6 month
Secondary outcomes:
Other outcomes:
Locations:
city: Keelung
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
affiliation: CHANG GUNG MEMORIAL HOSTIPAL, KEELUNG
name: MIN-HUI LIU, RN, PhD
role: PRINCIPAL_INVESTIGATOR
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