Effectiveness of TechCR Among CHD Patients

Study Overview
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Brief Summary
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During this ongoing pandemic, there is a crucial need for innovative approaches to deliver CR programmes other than frequent face-to-face sessions at the centre-based CR to reduce the number of times people come close in contact with others or gathering in large groups. This is a single setting, 2-arm parallel randomised clinical trial which aims to examine the effects of technology-assisted interventions in hybrid cardiac rehabilitation (TecHCR) among the coronary heart disease patients. Eligible participants will be randomly assigned into either intervention group (IG) or control group (CG) in 1:1 ratio using the computerised permuted blocks, alternating block sizes of 4 or 6. All participants will be followed up for three months and six months with data collection at baseline, (T0), three-month (T1) and six-month (T2) time points.

Detailed Description
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In recent years, CR delivery platforms and approaches have been changing as technology has become an integral part of our daily lives. Some of the barriers to CR may be able to be tackled with the advancement of technology, as it provides an alternative to the traditional centre-based CR through virtual consultations and remote monitoring that may eliminate the hassle of face-to-face consultations, work and time conflicts. During this ongoing pandemic, there is a crucial need for innovative approaches to deliver CR programmes other than frequent face-to-face sessions at the centre-based CR to reduce the number of times people come close in contact with others or gathering in large groups. The overall aim of this proposed study is to examine the effects of technology-assisted interventions in hybrid cardiac rehabilitation (TecHCR) among the coronary heart disease patients. The objectives are as followings: to determine the effects of TecHCR on self-efficacy related to exercise; to determine the effects of TecHCR on health promoting behaviours; to determine the effects of TecHCR in adherence; to determine the effects of TecHCR in exercise capacity; to determine the effects of TecHCR on fasting low density lipoprotein (LDL), high density lipoprotein (HDL), total cholesterol, systolic blood pressure, diastolic blood pressure, body mass index and waist circumference; to determine the effects of TecHCR anxiety and depression. With the attrition rate of 20%, a total of 160 eligible participants with 80 per group will be recruited. The control group receives usual care including outpatient medical follow-up with the cardiologists and dietician counselling before hospital discharge. Then, the participants will have their first follow-up by the physicians in cardiac rehabilitation clinic and followed by monthly follow-up. Subsequently, they will have weekly, centre-based supervised exercise training by physiotherapist and follow-up with occupational therapist for 12 weeks. In addition of the usual care of outpatient medical follow-ups and dietary education, the intervention group will receive 3 times supervised exercise in the centre, weekly upload of CR education (audio-visual video) on WhatsApp for six weeks (Week 1 to Week 6). The prescribed exercise will then be continued at home with a pedometer as the cue to action to be worn by the participant; he or she will be required to upload the data daily to the web app on the smartphone. Participants will also receive a weekly audio/video-conferencing follow-up (Week 1 to Week 12). The outcome measures include Socio-demographic and Clinical Data, Bandura's exercise self efficacy scale (ESE), Health Promoting Lifestyle Profile II (HPLP II), adherence referring to the attendance to 12 weeks (supervised exercise training) for CG, and attendance (3 times supervised exercise training) and upload of exercise data (for 9 weeks) to web app for IG; and 12-week assessment for both groups, exercise capacity by Exercise Stress Test measuring the metabolic equivalents METs) and Hospital Anxiety and Depression Scale (HADS). The data entry and analysis will be performed using the IBM Social Package Statistical Software (SPSS) version 26.0 with a p value < 0.05 will be consider significant of the result.

Official Title
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Effectiveness of Technology-assisted Interventions in Hybrid Cardiac Rehabilitation (TechCR) Among Coronary Heart Disease Patients

Conditions
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Coronary Heart Disease

Intervention / Treatment
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* Behavioral: exercise training for TechCR
* Behavioral: audio/video conference
* Behavioral: educational video
* Behavioral: Daily log
* Behavioral: exercise training for centre-based


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adults ≥ 18 years old; patients with documented acute myocardial infarction, treated with thrombolysis, angioplasty or revascularisation surgery; patients who own a mobile phone with internet access; patients who have at least completion of primary school education; understand English or Malay language; patients who will return home for living after hospital discharge; patients who are medically stable and referred to CR programme and able to give informed consent to participate in this study. Exclusion Criteria: patients who are participating in other studies; patients who will undergo any repeat cardiac or other procedure in next 12 months; patients with comorbidities such as dementia, impaired hearing or vision or psychiatric illness which may affect the ability to participate in the CR programme; patients with pre-existing mobility problems which prevent them from exercising

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The eligible participants will be randomly assigned into either intervention group (IG) or control group (CG) in 1:1 ratio using the computerised permuted blocks, alternating block sizes of 4 or 6. Once the eligible participants have consented to participate and the baseline data is collected, they will be given an opaque sealed envelope prepared by an independent statistician (not involved in the research) with assignment information and group allocation specified in the envelope. According to Polit and Beck (2017), the risk of selection bias can be reduced through allocation concealment by shielding the researcher from knowing the next group allocation of an individual.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TecHCR<br>12 weeks Hybrid between supervised exercise training and video call sessions Educational videos Dietary and exercise log | Behavioral: exercise training for TechCR<br>* 3 times of supervised exercise training at the centre-based, outpatient cardiac rehabilitation clinic<br>Behavioral: audio/video conference<br>* weekly audio/video conference<br>Behavioral: educational video<br>* weekly for 6 weeks, duration of video about 10-15 minutes<br>Behavioral: Daily log<br>* daily dietary and exercise log<br>|
| Other: Centre-based<br>12 weeks usual care provided by the centre-based, outpatient cardiac rehabilitation clinic Dietary and exercise log | Behavioral: Daily log<br>* daily dietary and exercise log<br>Behavioral: exercise training for centre-based<br>* 6 times of supervised exercise training<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| self-efficacy related to exercise (Bandura's Exercise Self-efficacy) | Using Bandura's Exercise Self-efficacy to determine the effects of TecHCR on self-efficacy related to exercise before intervention (baseline) | Baseline (T0) - at 0 week, before initiation of interventions | 
| self-efficacy related to exercise (Bandura's Exercise Self-efficacy) | Using Bandura's Exercise Self-efficacy to determine the effects of TecHCR on self-efficacy related to exercise post intervention (at 3-month) | post intervention (T1) - at 12 weeks after initiation of interventions | 
| self-efficacy related to exercise (Bandura's Exercise Self-efficacy) | Using Bandura's Exercise Self-efficacy to determine the effects of TecHCR on self-efficacy related to exercise 3-month post intervention (T2) (at 6 month) | 6-month post intervention (T2) - at 36 weeks after initiation of interventions | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| behavioural outcomes (Health-promoting Lifestyle Profile II) | Using Health-promoting lifestyle Profile II to determine the effects of TecHCR on health promoting behaviours | Baseline (T0) - at 0 week, before initiation of interventions | 
| behavioural outcomes (Health-promoting Lifestyle Profile II) | Using Health-promoting lifestyle Profile II to determine the effects of TecHCR on health promoting behaviours | post intervention (T1) - at 12 weeks after initiation of interventions | 
| behavioural outcomes (Health-promoting Lifestyle Profile II) | Using Health-promoting lifestyle Profile II to determine the effects of TecHCR on health promoting behaviours | 6-month post intervention (T2) - at 36 weeks after initiation of interventions | 
| psychological outcomes (Hospital Anxiety and Depression Scale) | Using Hospital Anxiety and Depression Scale to determine the effects of TecHCR on anxiety and depression | Baseline (T0) - at 0 week, before initiation of interventions | 
| psychological outcomes (Hospital Anxiety and Depression Scale) | Using Hospital Anxiety and Depression Scale to determine the effects of TecHCR on anxiety and depression | post intervention (T1) - at 12 weeks after initiation of interventions | 
| psychological outcomes (Hospital Anxiety and Depression Scale) | Using Hospital Anxiety and Depression Scale to determine the effects of TecHCR on anxiety and depression | 6-month post intervention (T2) - at 36 weeks after initiation of interventions | 
| fasting low density lipoprotein (LDL), high density lipoprotein (HDL), total cholesterol (from laboratory blood test result) | to determine the effects of TecHCR on fasting low density lipoprotein (LDL), high density lipoprotein (HDL), total cholesterol (mmol/L) | Baseline (T0) - at 0 week, before initiation of interventions | 
| fasting low density lipoprotein (LDL), high density lipoprotein (HDL), total cholesterol (from laboratory blood test result) | to determine the effects of TecHCR on fasting low density lipoprotein (LDL), high density lipoprotein (HDL), total cholesterol (mmol/L) | post intervention (T1) - at 12 weeks after initiation of interventions | 
| fasting low density lipoprotein (LDL), high density lipoprotein (HDL), total cholesterol (from laboratory blood test result) | to determine the effects of TecHCR on fasting low density lipoprotein (LDL), high density lipoprotein (HDL), total cholesterol (mmol/L) | 6-month post intervention (T2) - at 36 weeks after initiation of interventions | 
| systolic and diastolic blood pressure (using blood pressure monitoring device) | to determine the effects of TecHCR on systolic and diastolic blood pressure | Baseline (T0) - at 0 week, before initiation of interventions | 
| systolic and diastolic blood pressure (using blood pressure monitoring device) | to determine the effects of TecHCR on systolic and diastolic blood pressure | post intervention (T1) - at 12 weeks after initiation of interventions | 
| systolic and diastolic blood pressure (using blood pressure monitoring device) | to determine the effects of TecHCR on systolic and diastolic blood pressure | 6-month post intervention (T2) - at 36 weeks after initiation of interventions | 
| Body Mass Index (BMI) (weight in kilogrammes*height in metres^2) | to determine the effects of TecHCR on BMI | Baseline (T0) - at 0 week, before initiation of interventions | 
| Body Mass Index (BMI) (weight in kilogrammes*height in metres^2) | to determine the effects of TecHCR on BMI | post intervention (T1) - at 12 weeks after initiation of interventions | 
| Body Mass Index (BMI) (weight in kilogrammes*height in metres^2) | to determine the effects of TecHCR on BMI | 6-month post intervention (T2) - at 36 weeks after initiation of interventions | 
| Waist circumference (measured by measuring tape in centimetres) | to determine the effects of TecHCR on waist circumference | Baseline (T0) - at 0 week, before initiation of interventions | 
| Waist circumference (measured by measuring tape in centimetres) | to determine the effects of TecHCR on waist circumference | post intervention (T1) - at 12 weeks after initiation of interventions | 
| Waist circumference (measured by measuring tape in centimetres) | to determine the effects of TecHCR on waist circumference | 6-month post intervention (T2) - at 36 weeks after initiation of interventions | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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technology-assisted interventions, hybrid cardiac rehabilitation, coronary heart disease