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

NCT04146766 | Completed

• 1 other identifier: 2-108-05-132
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

eHealth; Coronary Artery Disease; Quality of Life; Self-management

Keywords

Coronary artery disease; Remote Care; artificial intelligence; self-management; Quality of Life

Outcome Measures

Primary Outcomes (18)

• physiological indicators-HDL-C(T1)

  HDL-C, the unit is mg/dL

  T1-baseline

• physiological indicators-HDL-C(T2)

  HDL-C, the unit is mg/dL

  T2-three months later

• physiological indicators-HDL-C(T3)

  HDL-C, the unit is mg/dL

  T3-six months later

• physiological indicators-LDL-C(T1)

  LDL-C, the unit is mg/dL

  T1-baseline

• physiological indicators-LDL-C(T2)

  LDL-C, the unit is mg/dL

  T2-three months later

• physiological indicators-LDL-C(T3)

  LDL-C, the unit is mg/dL

  T3-six months later

• physiological indicators-Total Cholesterol(T1)

  Total Cholesterol, the unit is mg/dL

  T1-baseline

• physiological indicators-Total Cholesterol(T2)

  Total Cholesterol, the unit is mg/dL

  T2-three months later

• physiological indicators-Total Cholesterol(T3)

  Total Cholesterol, the unit is mg/dL

  T3-six months later

• physiological indicators-Triglyceride(T1)

  Triglyceride, the unit is mg/dL

  T1-baseline

• physiological indicators-Triglyceride(T2)

  Triglyceride, the unit is mg/dL

  T2-three months later

• physiological indicators-Triglyceride(T3)

  Triglyceride, the unit is mg/dL

  T3-six months later

• physiological indicators-GLU(T1)

  GLU, the unit is mg/dL

  T1-baseline

• physiological indicators-GLU(T2)

  GLU, the unit is mg/dL

  T2-three months later

• physiological indicators-GLU(T3)

  GLU, the unit is mg/dL

  T3-six months later

• physiological indicators-HbA1C(T1)

  HbA1C, the unit is %

  T1-baseline

• physiological indicators-HbA1C(T2)

  HbA1C, the unit is %

  T2-three months later

• physiological indicators-HbA1C(T3)

  HbA1C, the unit is %

  T3-six months later

Secondary Outcomes (3)

• self-management-T1

  T1-baseline

• self-management-T2

  T2-three months later

• self-management-T3

  T3-six months later

Other Outcomes (4)

• Quality of life scale-T1

  T1-baseline

• Quality of life scale-T2

  T2-three months later

• Quality of life scale-T3

  T3-six months later

Study Arms (2)

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.

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.

Combination Product: eHealth

Interventions

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

eHealth; wait list control

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Defense Medical Center, Taiwan: lead

Study Sites (1)

TSGH

Taipei, Taiwan

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Telemedicine

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Delivery of Health Care; Patient Care Management; Health Services Administration

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: wait list control group RCT

Study Record Dates

• First Submitted: October 22, 2019
• First Posted: October 31, 2019
• Study Start: September 18, 2019
• Primary Completion: July 15, 2020
• Study Completion: October 5, 2020
• Last Updated: March 3, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)