An Integrative Cardiac Rehabilitation Employing Smartphone Technology (iCREST) for Patients With Post-myocardial Infarction: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- Cardiac Rehabilitation (CR) Utilisation
研究概览
简要总结
Aim: To develop and field test an Integrative Cardiac Rehabilitation Employing Smartphone Technology (I-CREST) system, and evaluate its effects on CR utilization, cardiac self-efficacy, functional capacity, health-related quality of life (HRQoL), anxiety, depression, medication adherence, cardiac risk factor control and clinical outcomes among post-myocardial patients in Singapore.
Background: Centre-based cardiac rehabilitation (CBCR) participation rates among eligible patients remain low at 10-30% worldwide and less than 10% in Singapore, reportedly due to long-standing challenges surrounding accessibility, conflicting commitments, low socioeconomic status, and costs. A recent challenge is the COVID-19 pandemic, that resulted in the partial or complete closures of CBCR programmes Alternative strategies to deliver cardiac rehabilitation using novel technologies are needed to increase participation rates and improve health outcomes.
Design: A single-blinded two-arm randomised controlled trial (RCT) will be adopted.
Methodology: The is a two-phase study. Phase one involves the development and field-testing of the I-CREST system. The I-CREST system comprises of a smartphone application, a wearable heart rate monitor and a web-portal.
Phase two is a single-blinded two-arm RCT with repeated measures. 124 participants will be recruited from the National University Hospital in Singapore and will be randomly allocated to intervention or control group. Participants in the intervention group will receive the 6-week I-CREST intervention - including the newly developed I-CREST system, one face-to-face training session, and weekly telephone calls. The participants in the control group will receive the 4-week traditional CBCR.
Data will be collected at baseline, at 6 weeks (after completion of the CR programme), at 3months and at 6months from baseline. Sociodemographic and clinical data will also be collected. A cost-effectiveness analysis will also be performed to evaluate the feasibility of I-CREST compared to the CBCR platform. To assess the participants' experiences of the I-CREST system, a process evaluation will be undertaken at the conclusion of the study.
Significance. This study will generate insights into the suitability and effectiveness of I-CREST as an alternative to traditional CBCR outpatient services.
详细描述
Specific Aims
The primary aims of this study are:
- Develop and the field test the I-CREST system;
- Evaluate the effectiveness of I-CREST intervention on cardiac rehabilitation (CR) utilization, cardiac self-efficacy, functional capacity, health-related quality of life (HRQoL), anxiety, depression, medication adherence, cardiac risk factor control;
- Evaluate the cost-effectiveness of I-CREST intervention compared with a traditional CBCR programme; and
- Explore participants' perceptions with regards to the usability, utility, acceptability, strengths, and weaknesses of the I-CREST intervention.
Study Hypotheses
Study participants will be randomised into either the experimental group (receive the I-CREST intervention) or to the control group (receive the traditional CBCR provided by the hospital). Compared to the control group, it is hypothesized that the experimental group will have:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a confirmed medical diagnosis of acute MI
- •are planning to be discharged to home
- •do not intend to join any other CR programmes offered by other institutions
- •at least 21 years old
- •use smart mobile phone in their daily lives frequently and who have the basic knowledge on app use; and
- •Able to speak and understand English or Chinese.
排除标准
- •Have suffered severe complications such as uncontrolled arrhythmias, heart failure with ejection fraction (EF) < 40%;
- •Are scheduled for coronary artery bypass grafting (CABG);
- •Have undergone cancer treatment, and other illnesses that will limit participation;
- •Have readmission plans for further revascularisation;
- •Have implanted devices;
- •Have a known history of major psychiatric illness;
- •Have pre-existing mobility problems; and
- •Have major reading and/or hearing difficulties.
结局指标
主要结局
Cardiac Rehabilitation (CR) Utilisation
时间窗: Data will be collected at 6 weeks
As measured by CR uptake (defined as attending baseline assessment, and at least one exercise session for CBCR, or the uploading of at least one set of exercise data to the web-portal for i-CREST group), CR adherence (defined as attending 8 of 12 exercise sessions for CBCR or uploading of 4 weeks' exercise data for I-CREST group) and CR completion (defined as attending all 12 exercise sessions for CBCR and uploading of the whole 6-week's exercised data for I-CREST group).
次要结局
- Cardiac Self-Efficacy(Data will be collected prior to the commencement of the programme (baseline), at 6 weeks, 3 months and again at 6 months from baseline)
- Perceived social support(Data will be collected prior to the commencement of the programme (baseline), at 6 weeks, 3 months and again at 6 months from baseline)
- Cardiac Risk Factors - Fasting blood glucose(Data will be collected prior to the commencement of the programme (baseline), at 6 weeks, 3 months and again at 6 months from baseline)
- Anxiety and depression levels(Data will be collected prior to the commencement of the programme (baseline), at 6 weeks, 3 months and again at 6 months from baseline)
- Health-related Quality of Life (HRQoL) - specific(Data will be collected prior to the commencement of the programme (baseline), at 6 weeks, 3 months and again at 6 months from baseline)
- Health-related Quality of Life (HRQoL) - generic(Data will be collected prior to the commencement of the programme (baseline), at 6 weeks, 3 months and again at 6 months from baseline)
- Physical Functional Capacity(Data will be collected prior to the commencement of the programme (baseline), at 6 weeks, 3 months and again at 6 months from baseline)
- Cardiac Risk Factors - Body mass index(Data will be collected prior to the commencement of the programme (baseline), at 6 weeks, 3 months and again at 6 months from baseline)
- Cardiac Risk Factors - Smoking status(Data will be collected prior to the commencement of the programme (baseline), at 6 weeks, 3 months and again at 6 months from baseline)
- Cardiac Risk Factors - Lipid profile(Data will be collected prior to the commencement of the programme (baseline), at 6 weeks, 3 months and again at 6 months from baseline)
- Self-regulatory behaviour(Data will be collected prior to the commencement of the programme (baseline), at 6 weeks, 3 months and again at 6 months from baseline)
- Medication adherence(Data will be collected prior to the commencement of the programme (baseline), at 6 weeks, 3 months and again at 6 months from baseline)
- Cardiac Risk Factors - Blood Pressure(Data will be collected prior to the commencement of the programme (baseline), at 6 weeks, 3 months and again at 6 months from baseline)
研究者
Wang Wenru
Associate Professor
National University of Singapore