Ignite Creation Date:
2024-05-06 @ 4:03 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04858503
Status:
RECRUITING
Last Update Posted:
2023-12-04
First Post:
2021-04-21
Brief Title:
An Internet-based Cardiac Rehabilitation Enhancement i-CARE Intervention to Support Self-care of Patients With Coronary Artery Disease
Sponsor:
The University of Hong Kong
Organization:
The University of Hong Kong
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 systemsAs 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
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 systemsAs 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None