eHealthNCT04146766
Effectiveness of eHealth on the Self-management of Health Status and QOL Among CAD Patients
A study testing eHealth in people with eHealth and Coronary Artery Disease, run by National Defense Medical Center, Taiwan at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- eHealth, Coronary Artery Disease, Quality of Life
- What is being tested?
- eHealth
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 18 Sep 2019to 5 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of eHealth on the Self-management, Physiological Health and Quality of Life Among Coronary Artery Disease 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.
Read the 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.
- Conditions
- eHealth, Coronary Artery Disease, Quality of Life, Self-management
- Being tested
- eHealth
- Keywords
- Coronary artery disease, Remote Care, artificial intelligence, self-management, Quality of Life
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eHealthCombination 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
| Study group | Role | What they receive |
|---|---|---|
| eHealth | Experimental | 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. Receives: Combination Product: eHealth |
| wait list control | Experimental | 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. Receives: Combination Product: eHealth |
What is being measured
The primary outcome is the main question the study is designed to answer.
physiological indicators-HDL-C(T1)
HDL-C, the unit is mg/dL
Measured: T1-baseline
physiological indicators-HDL-C(T2)
HDL-C, the unit is mg/dL
Measured: T2-three months later
physiological indicators-HDL-C(T3)
HDL-C, the unit is mg/dL
Measured: T3-six months later
physiological indicators-LDL-C(T1)
LDL-C, the unit is mg/dL
Measured: T1-baseline
physiological indicators-LDL-C(T2)
LDL-C, the unit is mg/dL
Measured: T2-three months later
physiological indicators-LDL-C(T3)
LDL-C, the unit is mg/dL
Measured: T3-six months later
physiological indicators-Total Cholesterol(T1)
Total Cholesterol, the unit is mg/dL
Measured: T1-baseline
physiological indicators-Total Cholesterol(T2)
Total Cholesterol, the unit is mg/dL
Measured: T2-three months later
physiological indicators-Total Cholesterol(T3)
Total Cholesterol, the unit is mg/dL
Measured: T3-six months later
physiological indicators-Triglyceride(T1)
Triglyceride, the unit is mg/dL
Measured: T1-baseline
physiological indicators-Triglyceride(T2)
Triglyceride, the unit is mg/dL
Measured: T2-three months later
physiological indicators-Triglyceride(T3)
Triglyceride, the unit is mg/dL
Measured: T3-six months later
physiological indicators-GLU(T1)
GLU, the unit is mg/dL
Measured: T1-baseline
physiological indicators-GLU(T2)
GLU, the unit is mg/dL
Measured: T2-three months later
physiological indicators-GLU(T3)
GLU, the unit is mg/dL
Measured: T3-six months later
physiological indicators-HbA1C(T1)
HbA1C, the unit is %
Measured: T1-baseline
physiological indicators-HbA1C(T2)
HbA1C, the unit is %
Measured: T2-three months later
physiological indicators-HbA1C(T3)
HbA1C, the unit is %
Measured: T3-six months later
Secondary outcomes (3)
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.
Measured: T1-baseline
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.
Measured: T2-three months later
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.
Measured: T3-six months later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2019
- Study start18 Sep 2019
- Primary completion15 Jul 2020
- Study completion5 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for eHealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- wait list control group RCT
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Defense Medical Center, Taiwan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hui-Hsun Chiang, National Defense Medical Center, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04146766
- Sponsor's protocol ID
- 2-108-05-132
- Status last verified
- Mar 2021
- First submitted
- 22 Oct 2019
- Last updated
- 3 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of eHealth on the Self-management, Physiological Health and Quality of Life Among Coronary Artery Disease Patients
- ClinicalTrials.gov ID
- NCT04146766
- Acronym / sponsor ID
- 2-108-05-132
- Conditions
- eHealth, Coronary Artery Disease, Quality of Life, Self-management
- Keywords
- Coronary artery disease, Remote Care, artificial intelligence, self-management, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- National Defense Medical Center, TaiwanUniversity, hospital or other
- Study start
- 18 Sep 2019 (actual)
- Primary completion
- 15 Jul 2020 (actual)
- Study completion
- 5 Oct 2020 (actual)
- First posted
- 31 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- wait list control group RCT
| Arm | Type | Receives |
|---|---|---|
| eHealth | Experimental | Combination Product: eHealthProvide 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 | Experimental | Combination Product: eHealthwait 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| eHealthThe 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 | Combination product | eHealth, wait list control |
Primary outcome
physiological indicators-HDL-C(T1)
Time frame: T1-baseline
HDL-C, the unit is mg/dL
physiological indicators-HDL-C(T2)
Time frame: T2-three months later
HDL-C, the unit is mg/dL
physiological indicators-HDL-C(T3)
Time frame: T3-six months later
HDL-C, the unit is mg/dL
physiological indicators-LDL-C(T1)
Time frame: T1-baseline
LDL-C, the unit is mg/dL
physiological indicators-LDL-C(T2)
Time frame: T2-three months later
LDL-C, the unit is mg/dL
physiological indicators-LDL-C(T3)
Time frame: T3-six months later
LDL-C, the unit is mg/dL
physiological indicators-Total Cholesterol(T1)
Time frame: T1-baseline
Total Cholesterol, the unit is mg/dL
physiological indicators-Total Cholesterol(T2)
Time frame: T2-three months later
Total Cholesterol, the unit is mg/dL
physiological indicators-Total Cholesterol(T3)
Time frame: T3-six months later
Total Cholesterol, the unit is mg/dL
physiological indicators-Triglyceride(T1)
Time frame: T1-baseline
Triglyceride, the unit is mg/dL
physiological indicators-Triglyceride(T2)
Time frame: T2-three months later
Triglyceride, the unit is mg/dL
physiological indicators-Triglyceride(T3)
Time frame: T3-six months later
Triglyceride, the unit is mg/dL
physiological indicators-GLU(T1)
Time frame: T1-baseline
GLU, the unit is mg/dL
physiological indicators-GLU(T2)
Time frame: T2-three months later
GLU, the unit is mg/dL
physiological indicators-GLU(T3)
Time frame: T3-six months later
GLU, the unit is mg/dL
physiological indicators-HbA1C(T1)
Time frame: T1-baseline
HbA1C, the unit is %
physiological indicators-HbA1C(T2)
Time frame: T2-three months later
HbA1C, the unit is %
physiological indicators-HbA1C(T3)
Time frame: T3-six months later
HbA1C, the unit is %
3 secondary outcomes
self-management-T1
Time frame: T1-baseline
self-management-T2
Time frame: T2-three months later
self-management-T3
Time frame: T3-six months later
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing eHealth in people with eHealth and Coronary Artery Disease, run by National Defense Medical Center, Taiwan at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
physiological indicators-HDL-C(T1) (time frame: T1-baseline). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2021.