An Internet-based Cardiac Rehabilitation Enhancement (i-CARE) Intervention to Support Self-care of Patients With Coronary Artery Disease
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| ClinicalTrials.gov Identifier: NCT04858503 |
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Recruitment Status :
Not yet recruiting
First Posted : April 26, 2021
Last Update Posted : October 5, 2021
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Coronary Artery Disease | Other: internet-based cardiac rehabilitation enhancement intervention | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 268 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Outcomes Assessor) |
| Primary Purpose: | Other |
| 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 |
| Estimated Study Start Date : | November 1, 2021 |
| Estimated Primary Completion Date : | June 30, 2023 |
| Estimated Study Completion Date : | August 31, 2023 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: internet-based cardiac rehabilitation enhancement intervention
internet-based cardiac rehabilitation enhancement intervention
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Other: internet-based cardiac rehabilitation enhancement intervention
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. |
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No Intervention: conventional cares as arranged by hospital or community centers
Participants will receive conventional cares as arranged by hospital or community centers
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- Self-care behaviour [ Time Frame: Change from Baseline at the 3 months (after the intervention) and 6 months (follow up) ]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.
- Biomarkers: lipid profile [ Time Frame: Change from Baseline at the 3 months (after the intervention) and 6 months (follow up) ]POCT
- Physiological: blood pressure [ Time Frame: Change from Baseline at the 3 months (after the intervention) and 6 months (follow up) ]Measure both systolic and diastolic blood pressure
- Anthropometric: waist-to-height ratio [ Time Frame: Change from Baseline at the 3 months (after the intervention) and 6 months (follow up) ]Measure waist-to-height ratio
- Clinical: Cardiovascular event rates and mortality [ Time Frame: Change from Baseline at the 3 months (after the intervention) and 6 months (follow up) ]the admissions, cardiovascular event rates and mortality data will be retrieved
- Self-reported health outcomes: functional status [ Time Frame: Change from Baseline at the 3 months (after the intervention) and 6 months (follow up) ]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) [ Time Frame: Change from Baseline at the 3 months (after the intervention) and 6 months (follow up) ]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.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04858503
| Contact: Polly Li, Dr | 852-39176686 | pwcli@hku.hk |
| Hong Kong | |
| The School of Nursing | |
| Hong Kong, Hong Kong | |
| Principal Investigator: | Polly Li, Dr | The University of Hong Kong, School of Nursing |
Documents provided by Dr. Polly Wai-Chi Li, The University of Hong Kong:
| Responsible Party: | Dr. Polly Wai-Chi Li, Assistant Professor, The University of Hong Kong |
| ClinicalTrials.gov Identifier: | NCT04858503 |
| Other Study ID Numbers: |
NTWC/REC/20139 |
| First Posted: | April 26, 2021 Key Record Dates |
| Last Update Posted: | October 5, 2021 |
| Last Verified: | September 2021 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Self-care Model of care Mobile app Empowerment |
Nurse-led Disease Management Risk factor control |
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Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Diseases |
Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases |