Effectiveness of eHealth on the Self-management of Health Status and QOL Among CAD Patients

Coronary Artery Disease Clinical Trial

Official title:

Effectiveness of eHealth on the Self-management, Physiological Health and Quality of Life Among Coronary Artery Disease Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04146766
• Other study ID #: 2-108-05-132
• Status: Completed
• Phase: N/A
• Start date: September 18, 2019
• Est. completion date: October 5, 2020

Study information

• Verified date: March 2021
• Source: National Defense Medical Center, Taiwan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This article uses the smart medical case management tracking system, combined with various terminal devices to fully record the measured data (pulse, blood pressure) for case home care tracking to prevent the occurrence and deterioration of the disease. Therefore, with the promotion of the eHealth medical staff and members of the family can instantly grasp the health of the body and cultivate the habits of self-health management and enhance the quality of care. Therefore, we hope to use the Smart Health Cloud as an interventional measure to improve the care of patients with coronary artery disease, improve self-management ability and quality of life.

Description:

The World Health Organization points out that cardiovascular disease is the number one killer of global deaths, killing 17.1 million people worldwide each year, accounting for 31% of the world's total deaths. Heart disease is the second leading cause of death in China. Coronary artery disease (CAD) is the majority, and coronary artery disease is the most common cardiovascular disease. Good self-management can reduce disease risk factors and improve related prognosis. It is also an important issue in health promotion around the world. This article uses the smart medical case management tracking system, combined with various terminal devices to fully record the measured data (pulse, blood pressure) for case home care tracking to prevent the occurrence and deterioration of the disease. Therefore, with the promotion of the eHealth medical staff and members of the family can instantly grasp the health of the body and cultivate the habits of self-health management and enhance the quality of care. Therefore, we hope to use the Smart Health Cloud as an interventional measure to improve the care of patients with coronary artery disease, improve self-management ability and quality of life.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 5, 2020
• Est. primary completion date: July 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• A patient who is 20 years of age or older and has a Coronary computed tomography angiography >50% vascular stenosis, has been PTCA?stent or CABG
• Taiwanese, understand Chinese

Exclusion Criteria:

• Those who can't express their wishes clearly (such as Azheimer's disease, mental dysfunction)
• mental disorder
• infectious diseases
• Patients who participate in other research projects

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• eHealth
• Myocardial Ischemia
• Quality of Life
• Self-management

Intervention

Combination Product:
• eHealth
The study was randomized (wait-list-control), and it was estimated that 60 subjects were randomly assigned to the immediate treatment group and the wait-list-control group. The two groups were tested for baseline before intervention in the eHealth. After the first questionnaire evaluation, the experimental group was involved in the eHealth for three months, and after three months, the experimental group and the waiting intervention control group were post-tested. To assess the effectiveness of the two groups before and after the eHealth . Control group that waits for intervention in the fourth month from the beginning of the fourth month to the end of the sixth month

Locations

Country	Name	City	State
Taiwan	TSGH	Taipei city

Sponsors (1)

Lead Sponsor	Collaborator
National Defense Medical Center, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Quality of life scale-T1	use WHOQOL-BREF Taiwan Version. total of 28 questions,The scoring method uses the five-point Likert Scales score The questionnaire has a total of 28 questions, with at least one point for each question and a maximum of five points. The higher the score, the better the quality of life.	T1-baseline
Other	Quality of life scale-T2	use WHOQOL-BREF Taiwan Version. total of 28 questions,The scoring method uses the five-point Likert Scales score The questionnaire has a total of 28 questions, with at least one point for each question and a maximum of five points. The higher the score, the better the quality of life.	T2-three months later
Other	Quality of life scale-T3	use WHOQOL-BREF Taiwan Version. total of 28 questions,The scoring method uses the five-point Likert Scales score The questionnaire has a total of 28 questions, with at least one point for each question and a maximum of five points. The higher the score, the better the quality of life.	T3-six months later
Other	Modified Health care machine rating scale	There are three questions in the satisfaction survey. Use category options to measure usage satisfaction	T2-three months later
Primary	physiological indicators-HDL-C(T1)	HDL-C, the unit is mg/dL	T1-baseline
Primary	physiological indicators-HDL-C(T2)	HDL-C, the unit is mg/dL	T2-three months later
Primary	physiological indicators-HDL-C(T3)	HDL-C, the unit is mg/dL	T3-six months later
Primary	physiological indicators-LDL-C(T1)	LDL-C, the unit is mg/dL	T1-baseline
Primary	physiological indicators-LDL-C(T2)	LDL-C, the unit is mg/dL	T2-three months later
Primary	physiological indicators-LDL-C(T3)	LDL-C, the unit is mg/dL	T3-six months later
Primary	physiological indicators-Total Cholesterol(T1)	Total Cholesterol, the unit is mg/dL	T1-baseline
Primary	physiological indicators-Total Cholesterol(T2)	Total Cholesterol, the unit is mg/dL	T2-three months later
Primary	physiological indicators-Total Cholesterol(T3)	Total Cholesterol, the unit is mg/dL	T3-six months later
Primary	physiological indicators-Triglyceride(T1)	Triglyceride, the unit is mg/dL	T1-baseline
Primary	physiological indicators-Triglyceride(T2)	Triglyceride, the unit is mg/dL	T2-three months later
Primary	physiological indicators-Triglyceride(T3)	Triglyceride, the unit is mg/dL	T3-six months later
Primary	physiological indicators-GLU(T1)	GLU, the unit is mg/dL	T1-baseline
Primary	physiological indicators-GLU(T2)	GLU, the unit is mg/dL	T2-three months later
Primary	physiological indicators-GLU(T3)	GLU, the unit is mg/dL	T3-six months later
Primary	physiological indicators-HbA1C(T1)	HbA1C, the unit is %	T1-baseline
Primary	physiological indicators-HbA1C(T2)	HbA1C, the unit is %	T2-three months later
Primary	physiological indicators-HbA1C(T3)	HbA1C, the unit is %	T3-six months later
Secondary	self-management-T1	use The partners in Health scale. total of 12 questions,The scoring method uses the nine-point Likert Scales score. The score of 0 is divided into self-management performance, and the score of 8 indicates that self-management is good. The total score is 96 points. The higher the score, the better the self-management.	T1-baseline
Secondary	self-management-T2	use The partners in Health scale. total of 12 questions,The scoring method uses the nine-point Likert Scales score. The score of 0 is divided into self-management performance, and the score of 8 indicates that self-management is good. The total score is 96 points. The higher the score, the better the self-management.	T2-three months later
Secondary	self-management-T3	use The partners in Health scale. total of 12 questions,The scoring method uses the nine-point Likert Scales score. The score of 0 is divided into self-management performance, and the score of 8 indicates that self-management is good. The total score is 96 points. The higher the score, the better the self-management.	T3-six months later