An Internet-based Cardiac Rehabilitation Enhancement (i-CARE) Intervention to Support Self-care of Patients With Coronary Artery Disease
Primary Purpose
Coronary Artery Disease
Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
internet-based cardiac rehabilitation enhancement intervention
Sponsored by
About this trial
This is an interventional other trial for Coronary Artery Disease focused on measuring Self-care, Model of care, Mobile app, Empowerment, Nurse-led, Disease Management, Risk factor control
Eligibility Criteria
Inclusion Criteria:
- ≥18 years of age
- living in the community,
- own a smartphone with internet access,
- communicable in Cantonese,
- type in Chinese or English,
- with a confirmed diagnosis of CAD.
Exclusion Criteria:
- enrolled to a structured centre-based or home-based cardiac rehabilitation program, (2) psychiatric problems,
- impaired cognitive functioning (i.e. Abbreviated Mental Test ≤6), and
- terminal disease with life expectancy < 1 year.
Sites / Locations
- The School of NursingRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
internet-based cardiac rehabilitation enhancement intervention
conventional cares as arranged by hospital or community centers
Arm Description
internet-based cardiac rehabilitation enhancement intervention
Participants will receive conventional cares as arranged by hospital or community centers
Outcomes
Primary Outcome Measures
Self-care behaviour
the Chinese version of Self-Care of Coronary Heart Disease Inventory (SC-CHDI). This self-reported SC-CHDI (22 items) measures self-care maintenance, self-care management and self-care confidence on a four-point response scale. Each subscale score is transformed to 100 points, with higher scores indicate better self-care for that attribute.
Secondary Outcome Measures
Biomarkers: lipid profile
POCT
Physiological: blood pressure
Measure both systolic and diastolic blood pressure
Anthropometric: waist-to-height ratio
Measure waist-to-height ratio
Clinical: Cardiovascular event rates and mortality
the admissions, cardiovascular event rates and mortality data will be retrieved
Self-reported health outcomes: functional status
The functional status will be measured with the Chinese version of Seattle Angina Questionnaire. This 19-item questionnaire consists of five subscales, including physical limitation, angina stability, angina frequency, treatment satisfaction and the disease perception. The respondents have to rate on a 1 to 5 or 6 sequentially coded status. The subscale scores are transformed to a scale of 0 to 100, with higher scores indicate higher level of functioning/ satisfaction and fewer limitations.
Health-related Quality of life (HRQoL)
The Chinese version of MacNew will be used to measure disease-specific HRQoL.22 It consists of 27 items measuring HRQoL in three domains (physical, emotional and social). Each item is rated on a 1-7 scale, and a global score is calculated by summing the item scores, a higher score represents better HRQoL.
Full Information
NCT ID
NCT04858503
First Posted
April 21, 2021
Last Updated
August 3, 2022
Sponsor
The University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT04858503
Brief Title
An Internet-based Cardiac Rehabilitation Enhancement (i-CARE) Intervention to Support Self-care of Patients With Coronary Artery Disease
Official Title
An Internet-based Cardiac Rehabilitation Enhancement (i-CARE) Intervention to Support Self-care of Patients With Coronary Artery Disease: A Mixed-method Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
August 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Hong Kong
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 study aims to examine the effects of an internet-based cardica rehabilitation enhancement (i-CARE) programme for coronary artery disease (CAD) patients on self-care behaviour, biomarkers, physiological, anthropometric parameters, clinical outcomes and self-reported health outcomes and to understand why and how i-CARE influences patients' health behaviours.
Detailed Description
This study aims to examine the effects of an internet-based cardica rehabilitation enhancement (i-CARE) programme for coronary artery disease (CAD) patients on self-care behaviour, biomarkers, physiological, anthropometric parameters, clinical outcomes and self-reported health outcomes and to understand why and how i-CARE influences patients' health behaviours.
Cardiovascular disease, a highly prevalent morbidity, is the number one cause of death worldwide and has become a significant public health concern. The majority of these deaths are attributed to an acute manifestation of coronary artery disease (CAD), defined as a narrowing of the coronary arteries that causes insufficient myocardial blood flow. CAD has reached an unequivocal pandemic status globally and locally. CAD imposes not only significant physical and psychosocial burdens on patients, but also enormous service demands on healthcare systems.As a chronic condition, CAD requires patients to practice persistent self-care in a long-term manner for successful disease management. Self-care is considered fundamental to the prevention and management of chronic diseases. Yet, a significant proportion of the CAD population is still engaging in full-time employment, their time availability restricts them to participate in traditional health promotional activities. According to recent systematic reviews, substantial evidence has accumulated to support the positive effects of internet-delivered interventions. Therefore, an internet-based approach with self-care cardiac rehabilitation enhancement may be ab better method of engaging patients in the learning process and arousing their inherent capacities to maintain behavioral modifications. This mixed-method study consists of a two-arm randomized controlled trial and an exploratory qualitative study. For the randomized controlled trial plans to recruit 268 adults from Queen Mary Hospital and Care for Your Heart. Eligible participants will be CAD patients who aged 18 above, living in the community, owning a smartphone with internet access, communicable in Cantonese and able to type in Chinese or English. The participants will be randomly allocated to the intervention or control group to receive i-CARE or usual care, respectively. The study hypotheizes that the CAD patients who receive the i-CARE intervention will report better changes in self-care behaviours, blood pressure, cholesterols, waist-to-height ratio, functional status and HRQoL at 3 and 6 months after the intervention, than those who receive usual care and that the CAD patients who receive the i-CARE intervention will report fewer cardiovascular event rates and mortality at 6 months after the intervention, than those who receive usual care. The findings will advance our knowledge of the empirical effects of internet-based cardiac rehabilitation programme on CAD patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Self-care, Model of care, Mobile app, Empowerment, Nurse-led, Disease Management, Risk factor control
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
268 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
internet-based cardiac rehabilitation enhancement intervention
Arm Type
Experimental
Arm Description
internet-based cardiac rehabilitation enhancement intervention
Arm Title
conventional cares as arranged by hospital or community centers
Arm Type
No Intervention
Arm Description
Participants will receive conventional cares as arranged by hospital or community centers
Intervention Type
Other
Intervention Name(s)
internet-based cardiac rehabilitation enhancement intervention
Intervention Description
Participants in the intervention group will receive a 12-week i-CARE intervention, which will be designed to cover the core elements of CAD self-care: self-care maintenance, self-care monitoring and self-care management. The intervention will comprise: 1) a single individualized face-to-face session and 2) an internet-based intervention through a mobile application. Various behaviour change techniques will be used to increase the self-efficacy of CAD patients in enacting self-care behaviours.
Primary Outcome Measure Information:
Title
Self-care behaviour
Description
the Chinese version of Self-Care of Coronary Heart Disease Inventory (SC-CHDI). This self-reported SC-CHDI (22 items) measures self-care maintenance, self-care management and self-care confidence on a four-point response scale. Each subscale score is transformed to 100 points, with higher scores indicate better self-care for that attribute.
Time Frame
Change from Baseline at the 3 months (after the intervention) and 6 months (follow up)
Secondary Outcome Measure Information:
Title
Biomarkers: lipid profile
Description
POCT
Time Frame
Change from Baseline at the 3 months (after the intervention) and 6 months (follow up)
Title
Physiological: blood pressure
Description
Measure both systolic and diastolic blood pressure
Time Frame
Change from Baseline at the 3 months (after the intervention) and 6 months (follow up)
Title
Anthropometric: waist-to-height ratio
Description
Measure waist-to-height ratio
Time Frame
Change from Baseline at the 3 months (after the intervention) and 6 months (follow up)
Title
Clinical: Cardiovascular event rates and mortality
Description
the admissions, cardiovascular event rates and mortality data will be retrieved
Time Frame
Change from Baseline at the 3 months (after the intervention) and 6 months (follow up)
Title
Self-reported health outcomes: functional status
Description
The functional status will be measured with the Chinese version of Seattle Angina Questionnaire. This 19-item questionnaire consists of five subscales, including physical limitation, angina stability, angina frequency, treatment satisfaction and the disease perception. The respondents have to rate on a 1 to 5 or 6 sequentially coded status. The subscale scores are transformed to a scale of 0 to 100, with higher scores indicate higher level of functioning/ satisfaction and fewer limitations.
Time Frame
Change from Baseline at the 3 months (after the intervention) and 6 months (follow up)
Title
Health-related Quality of life (HRQoL)
Description
The Chinese version of MacNew will be used to measure disease-specific HRQoL.22 It consists of 27 items measuring HRQoL in three domains (physical, emotional and social). Each item is rated on a 1-7 scale, and a global score is calculated by summing the item scores, a higher score represents better HRQoL.
Time Frame
Change from Baseline at the 3 months (after the intervention) and 6 months (follow up)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
≥18 years of age
living in the community,
own a smartphone with internet access,
communicable in Cantonese,
type in Chinese or English,
with a confirmed diagnosis of CAD.
Exclusion Criteria:
enrolled to a structured centre-based or home-based cardiac rehabilitation program, (2) psychiatric problems,
impaired cognitive functioning (i.e. Abbreviated Mental Test ≤6), and
terminal disease with life expectancy < 1 year.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Polly Li, Dr
Phone
852-39176686
Email
pwcli@hku.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Polly Li, Dr
Organizational Affiliation
The University of Hong Kong, School of Nursing
Official's Role
Principal Investigator
Facility Information:
Facility Name
The School of Nursing
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Polly Li, Dr
Phone
852-3917-6686
Email
pwcli@hku.hk
12. IPD Sharing Statement
Learn more about this trial
An Internet-based Cardiac Rehabilitation Enhancement (i-CARE) Intervention to Support Self-care of Patients With Coronary Artery Disease
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