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NCT Number: NCT04146766

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

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.

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Key information

Conditions

eHealth Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Disease Heart Diseases Myocardial Ischemia Quality of Life Self-management Vascular Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

TSGH

Taipei, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

eHealth

Combination Product

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

Primary outcomes

  1. physiological indicators-HDL-C(T1)

    Time frame: T1-baseline

    HDL-C, the unit is mg/dL

  2. physiological indicators-HDL-C(T2)

    Time frame: T2-three months later

    HDL-C, the unit is mg/dL

  3. physiological indicators-HDL-C(T3)

    Time frame: T3-six months later

    HDL-C, the unit is mg/dL

  4. physiological indicators-LDL-C(T1)

    Time frame: T1-baseline

    LDL-C, the unit is mg/dL

  5. physiological indicators-LDL-C(T2)

    Time frame: T2-three months later

    LDL-C, the unit is mg/dL

  6. physiological indicators-LDL-C(T3)

    Time frame: T3-six months later

    LDL-C, the unit is mg/dL

  7. physiological indicators-Total Cholesterol(T1)

    Time frame: T1-baseline

    Total Cholesterol, the unit is mg/dL

  8. physiological indicators-Total Cholesterol(T2)

    Time frame: T2-three months later

    Total Cholesterol, the unit is mg/dL

  9. physiological indicators-Total Cholesterol(T3)

    Time frame: T3-six months later

    Total Cholesterol, the unit is mg/dL

  10. physiological indicators-Triglyceride(T1)

    Time frame: T1-baseline

    Triglyceride, the unit is mg/dL

  11. physiological indicators-Triglyceride(T2)

    Time frame: T2-three months later

    Triglyceride, the unit is mg/dL

  12. physiological indicators-Triglyceride(T3)

    Time frame: T3-six months later

    Triglyceride, the unit is mg/dL

  13. physiological indicators-GLU(T1)

    Time frame: T1-baseline

    GLU, the unit is mg/dL

  14. physiological indicators-GLU(T2)

    Time frame: T2-three months later

    GLU, the unit is mg/dL

  15. physiological indicators-GLU(T3)

    Time frame: T3-six months later

    GLU, the unit is mg/dL

  16. physiological indicators-HbA1C(T1)

    Time frame: T1-baseline

    HbA1C, the unit is %

  17. physiological indicators-HbA1C(T2)

    Time frame: T2-three months later

    HbA1C, the unit is %

  18. physiological indicators-HbA1C(T3)

    Time frame: T3-six months later

    HbA1C, the unit is %

Secondary outcomes

  1. self-management-T1

    Time frame: T1-baseline

    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.

  2. self-management-T2

    Time frame: T2-three months later

    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.

  3. self-management-T3

    Time frame: T3-six months later

    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.

Other outcomes

  1. Quality of life scale-T1

    Time frame: T1-baseline

    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.

  2. Quality of life scale-T2

    Time frame: T2-three months later

    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.

  3. Quality of life scale-T3

    Time frame: T3-six months later

    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.

  4. Modified Health care machine rating scale

    Time frame: T2-three months later

    There are three questions in the satisfaction survey. Use category options to measure usage satisfaction

Sponsors and collaborators

Lead sponsor

National Defense Medical Center, Taiwan

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 31, 2019
Registry last updated
Mar 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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