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

Primary Purpose

eHealth, Coronary Artery Disease, Quality of Life

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
eHealth
Sponsored by
National Defense Medical Center, Taiwan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for eHealth focused on measuring Coronary artery disease, Remote Care, artificial intelligence, self-management, Quality of Life

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • TSGH

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

eHealth

wait list control

Arm Description

Provide home physiology measurement services, including automatic uploading of measured blood pressure values to the cloud, serial back-end education platform to provide numerical anomaly alarms and health care notifications, monthly measurement data reports, combined with mobile APP management system for immediate enquiry . In addition to the electric visit to the patient's health education guidance, the content includes: 1. Encourage the walking exercise to perform 2. Ask the walking exercise execution progress, please return the daily value of the case to facilitate the record 3. Answer the relevant questions asked during the intervention.

wait list control for 3 months and then Provide home physiology measurement services, including automatic uploading of measured blood pressure values to the cloud, serial back-end education platform to provide numerical anomaly alarms and health care notifications, monthly measurement data reports, combined with mobile APP management system for immediate enquiry . In addition to the electric visit to the patient's health education guidance, the content includes: 1. Encourage the walking exercise to perform 2. Ask the walking exercise execution progress, please return the daily value of the case to facilitate the record 3. Answer the relevant questions asked during the intervention.

Outcomes

Primary Outcome Measures

physiological indicators-HDL-C(T1)
HDL-C, the unit is mg/dL
physiological indicators-HDL-C(T2)
HDL-C, the unit is mg/dL
physiological indicators-HDL-C(T3)
HDL-C, the unit is mg/dL
physiological indicators-LDL-C(T1)
LDL-C, the unit is mg/dL
physiological indicators-LDL-C(T2)
LDL-C, the unit is mg/dL
physiological indicators-LDL-C(T3)
LDL-C, the unit is mg/dL
physiological indicators-Total Cholesterol(T1)
Total Cholesterol, the unit is mg/dL
physiological indicators-Total Cholesterol(T2)
Total Cholesterol, the unit is mg/dL
physiological indicators-Total Cholesterol(T3)
Total Cholesterol, the unit is mg/dL
physiological indicators-Triglyceride(T1)
Triglyceride, the unit is mg/dL
physiological indicators-Triglyceride(T2)
Triglyceride, the unit is mg/dL
physiological indicators-Triglyceride(T3)
Triglyceride, the unit is mg/dL
physiological indicators-GLU(T1)
GLU, the unit is mg/dL
physiological indicators-GLU(T2)
GLU, the unit is mg/dL
physiological indicators-GLU(T3)
GLU, the unit is mg/dL
physiological indicators-HbA1C(T1)
HbA1C, the unit is %
physiological indicators-HbA1C(T2)
HbA1C, the unit is %
physiological indicators-HbA1C(T3)
HbA1C, the unit is %

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
October 22, 2019
Last Updated
March 1, 2021
Sponsor
National Defense Medical Center, Taiwan
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1. Study Identification

Unique Protocol Identification Number
NCT04146766
Brief Title
Effectiveness of eHealth on the Self-management of Health Status and QOL Among CAD Patients
Official Title
Effectiveness of eHealth on the Self-management, Physiological Health and Quality of Life Among Coronary Artery Disease Patients
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
September 18, 2019 (Actual)
Primary Completion Date
July 15, 2020 (Actual)
Study Completion Date
October 5, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Defense Medical Center, Taiwan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
eHealth, Coronary Artery Disease, Quality of Life, Self-management
Keywords
Coronary artery disease, Remote Care, artificial intelligence, self-management, Quality of Life

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
wait list control group RCT
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
eHealth
Arm Type
Experimental
Arm Description
Provide home physiology measurement services, including automatic uploading of measured blood pressure values to the cloud, serial back-end education platform to provide numerical anomaly alarms and health care notifications, monthly measurement data reports, combined with mobile APP management system for immediate enquiry . In addition to the electric visit to the patient's health education guidance, the content includes: 1. Encourage the walking exercise to perform 2. Ask the walking exercise execution progress, please return the daily value of the case to facilitate the record 3. Answer the relevant questions asked during the intervention.
Arm Title
wait list control
Arm Type
Experimental
Arm Description
wait list control for 3 months and then Provide home physiology measurement services, including automatic uploading of measured blood pressure values to the cloud, serial back-end education platform to provide numerical anomaly alarms and health care notifications, monthly measurement data reports, combined with mobile APP management system for immediate enquiry . In addition to the electric visit to the patient's health education guidance, the content includes: 1. Encourage the walking exercise to perform 2. Ask the walking exercise execution progress, please return the daily value of the case to facilitate the record 3. Answer the relevant questions asked during the intervention.
Intervention Type
Combination Product
Intervention Name(s)
eHealth
Intervention Description
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 Outcome Measure Information:
Title
physiological indicators-HDL-C(T1)
Description
HDL-C, the unit is mg/dL
Time Frame
T1-baseline
Title
physiological indicators-HDL-C(T2)
Description
HDL-C, the unit is mg/dL
Time Frame
T2-three months later
Title
physiological indicators-HDL-C(T3)
Description
HDL-C, the unit is mg/dL
Time Frame
T3-six months later
Title
physiological indicators-LDL-C(T1)
Description
LDL-C, the unit is mg/dL
Time Frame
T1-baseline
Title
physiological indicators-LDL-C(T2)
Description
LDL-C, the unit is mg/dL
Time Frame
T2-three months later
Title
physiological indicators-LDL-C(T3)
Description
LDL-C, the unit is mg/dL
Time Frame
T3-six months later
Title
physiological indicators-Total Cholesterol(T1)
Description
Total Cholesterol, the unit is mg/dL
Time Frame
T1-baseline
Title
physiological indicators-Total Cholesterol(T2)
Description
Total Cholesterol, the unit is mg/dL
Time Frame
T2-three months later
Title
physiological indicators-Total Cholesterol(T3)
Description
Total Cholesterol, the unit is mg/dL
Time Frame
T3-six months later
Title
physiological indicators-Triglyceride(T1)
Description
Triglyceride, the unit is mg/dL
Time Frame
T1-baseline
Title
physiological indicators-Triglyceride(T2)
Description
Triglyceride, the unit is mg/dL
Time Frame
T2-three months later
Title
physiological indicators-Triglyceride(T3)
Description
Triglyceride, the unit is mg/dL
Time Frame
T3-six months later
Title
physiological indicators-GLU(T1)
Description
GLU, the unit is mg/dL
Time Frame
T1-baseline
Title
physiological indicators-GLU(T2)
Description
GLU, the unit is mg/dL
Time Frame
T2-three months later
Title
physiological indicators-GLU(T3)
Description
GLU, the unit is mg/dL
Time Frame
T3-six months later
Title
physiological indicators-HbA1C(T1)
Description
HbA1C, the unit is %
Time Frame
T1-baseline
Title
physiological indicators-HbA1C(T2)
Description
HbA1C, the unit is %
Time Frame
T2-three months later
Title
physiological indicators-HbA1C(T3)
Description
HbA1C, the unit is %
Time Frame
T3-six months later
Secondary Outcome Measure Information:
Title
self-management-T1
Description
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.
Time Frame
T1-baseline
Title
self-management-T2
Description
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.
Time Frame
T2-three months later
Title
self-management-T3
Description
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.
Time Frame
T3-six months later
Other Pre-specified Outcome Measures:
Title
Quality of life scale-T1
Description
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.
Time Frame
T1-baseline
Title
Quality of life scale-T2
Description
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.
Time Frame
T2-three months later
Title
Quality of life scale-T3
Description
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.
Time Frame
T3-six months later
Title
Modified Health care machine rating scale
Description
There are three questions in the satisfaction survey. Use category options to measure usage satisfaction
Time Frame
T2-three months later

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
TSGH
City
Taipei city
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No

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

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