Clinical trial NCT04858503: 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
Overall status: RECRUITING
Phase: NA
Conditions: Coronary Artery Disease
Keywords: Self-care
Model of care
Mobile app
Empowerment
Nurse-led
Disease Management
Risk factor control
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2021-04-26
Enrollment: 268
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Self-care behaviour
timeFrame: Change from Baseline at the 3 months (after the intervention) and 6 months (follow up)
Secondary outcomes:
measure: Biomarkers: lipid profile
timeFrame: Change from Baseline at the 3 months (after the intervention) and 6 months (follow up)
measure: Physiological: blood pressure
timeFrame: Change from Baseline at the 3 months (after the intervention) and 6 months (follow up)
measure: Anthropometric: waist-to-height ratio
timeFrame: Change from Baseline at the 3 months (after the intervention) and 6 months (follow up)
measure: Clinical: Cardiovascular event rates and mortality
timeFrame: Change from Baseline at the 3 months (after the intervention) and 6 months (follow up)
measure: Self-reported health outcomes: functional status
timeFrame: Change from Baseline at the 3 months (after the intervention) and 6 months (follow up)
measure: Health-related Quality of life (HRQoL)
timeFrame: Change from Baseline at the 3 months (after the intervention) and 6 months (follow up)
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The School of Nursing
Study officials:
affiliation: The University of Hong Kong, School of Nursing
name: Polly Li, Dr
role: PRINCIPAL_INVESTIGATOR
References: