跳至主要内容
临床试验/NCT04858503
NCT04858503招募中不适用

An Internet-based Cardiac Rehabilitation Enhancement (i-CARE) Intervention to Support Self-care of Patients With Coronary Artery Disease: A Mixed-method Study

The University of Hong Kong1 个研究点 分布在 1 个国家目标入组 268 人开始时间: 2022年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
268
试验地点
1
主要终点
Self-care behaviour

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •≥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.

排除标准

  • •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.

研究组 & 干预措施

internet-based cardiac rehabilitation enhancement intervention

Experimental

internet-based cardiac rehabilitation enhancement intervention

干预措施: internet-based cardiac rehabilitation enhancement intervention (Other)

conventional cares as arranged by hospital or community centers

No Intervention

Participants will receive conventional cares as arranged by hospital or community centers

结局指标

主要结局

Self-care behaviour

时间窗: 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.

次要结局

  • Biomarkers: lipid profile(Change from Baseline at the 3 months (after the intervention) and 6 months (follow up))
  • Physiological: blood pressure(Change from Baseline at the 3 months (after the intervention) and 6 months (follow up))
  • Anthropometric: waist-to-height ratio(Change from Baseline at the 3 months (after the intervention) and 6 months (follow up))
  • Clinical: Cardiovascular event rates and mortality(Change from Baseline at the 3 months (after the intervention) and 6 months (follow up))
  • Self-reported health outcomes: functional status(Change from Baseline at the 3 months (after the intervention) and 6 months (follow up))
  • Health-related Quality of life (HRQoL)(Change from Baseline at the 3 months (after the intervention) and 6 months (follow up))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Polly Wai-Chi Li

Assistant Professor

The University of Hong Kong

研究点 (1)

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