Clinical trial NCT04862351: Effectiveness of TechCR Among CHD Patients
Official title: Effectiveness of Technology-assisted Interventions in Hybrid Cardiac Rehabilitation (TechCR) Among Coronary Heart Disease Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Heart Disease
Keywords: technology-assisted interventions
hybrid cardiac rehabilitation
coronary heart disease
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2021-04-28
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: OTHER

Brief summary: 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: 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:

1. to determine the effects of TecHCR on self-efficacy related to exercise;
2. to determine the effects of TecHCR on health promoting behaviours;
3. to determine the effects of TecHCR in adherence;
4. to determine the effects of TecHCR in exercise capacity;
5. 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;
6. 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.

Eligibility criteria: Inclusion Criteria:

1. adults ≥ 18 years old;
2. patients with documented acute myocardial infarction, treated with thrombolysis, angioplasty or revascularisation surgery;
3. patients who own a mobile phone with internet access;
4. patients who have at least completion of primary school education;
5. understand English or Malay language;
6. patients who will return home for living after hospital discharge;
7. patients who are medically stable and referred to CR programme and able to give informed consent to participate in this study.

Exclusion Criteria:

1. patients who are participating in other studies;
2. patients who will undergo any repeat cardiac or other procedure in next 12 months;
3. patients with comorbidities such as dementia, impaired hearing or vision or psychiatric illness which may affect the ability to participate in the CR programme;
4. patients with pre-existing mobility problems which prevent them from exercising

Primary outcomes:
measure: self-efficacy related to exercise (Bandura's Exercise Self-efficacy)
timeFrame: Baseline (T0) - at 0 week, before initiation of interventions
measure: self-efficacy related to exercise (Bandura's Exercise Self-efficacy)
timeFrame: post intervention (T1) - at 12 weeks after initiation of interventions
measure: self-efficacy related to exercise (Bandura's Exercise Self-efficacy)
timeFrame: 6-month post intervention (T2) - at 36 weeks after initiation of interventions
Secondary outcomes:
measure: behavioural outcomes (Health-promoting Lifestyle Profile II)
timeFrame: Baseline (T0) - at 0 week, before initiation of interventions
measure: behavioural outcomes (Health-promoting Lifestyle Profile II)
timeFrame: post intervention (T1) - at 12 weeks after initiation of interventions
measure: behavioural outcomes (Health-promoting Lifestyle Profile II)
timeFrame: 6-month post intervention (T2) - at 36 weeks after initiation of interventions
measure: psychological outcomes (Hospital Anxiety and Depression Scale)
timeFrame: Baseline (T0) - at 0 week, before initiation of interventions
measure: psychological outcomes (Hospital Anxiety and Depression Scale)
timeFrame: post intervention (T1) - at 12 weeks after initiation of interventions
measure: psychological outcomes (Hospital Anxiety and Depression Scale)
timeFrame: 6-month post intervention (T2) - at 36 weeks after initiation of interventions
measure: fasting low density lipoprotein (LDL), high density lipoprotein (HDL), total cholesterol (from laboratory blood test result)
timeFrame: Baseline (T0) - at 0 week, before initiation of interventions
measure: fasting low density lipoprotein (LDL), high density lipoprotein (HDL), total cholesterol (from laboratory blood test result)
timeFrame: post intervention (T1) - at 12 weeks after initiation of interventions
measure: fasting low density lipoprotein (LDL), high density lipoprotein (HDL), total cholesterol (from laboratory blood test result)
timeFrame: 6-month post intervention (T2) - at 36 weeks after initiation of interventions
measure: systolic and diastolic blood pressure (using blood pressure monitoring device)
timeFrame: Baseline (T0) - at 0 week, before initiation of interventions
measure: systolic and diastolic blood pressure (using blood pressure monitoring device)
timeFrame: post intervention (T1) - at 12 weeks after initiation of interventions
measure: systolic and diastolic blood pressure (using blood pressure monitoring device)
timeFrame: 6-month post intervention (T2) - at 36 weeks after initiation of interventions
measure: Body Mass Index (BMI) (weight in kilogrammes*height in metres^2)
timeFrame: Baseline (T0) - at 0 week, before initiation of interventions
measure: Body Mass Index (BMI) (weight in kilogrammes*height in metres^2)
timeFrame: post intervention (T1) - at 12 weeks after initiation of interventions
measure: Body Mass Index (BMI) (weight in kilogrammes*height in metres^2)
timeFrame: 6-month post intervention (T2) - at 36 weeks after initiation of interventions
measure: Waist circumference (measured by measuring tape in centimetres)
timeFrame: Baseline (T0) - at 0 week, before initiation of interventions
measure: Waist circumference (measured by measuring tape in centimetres)
timeFrame: post intervention (T1) - at 12 weeks after initiation of interventions
measure: Waist circumference (measured by measuring tape in centimetres)
timeFrame: 6-month post intervention (T2) - at 36 weeks after initiation of interventions
Other outcomes:
Locations:
city: Kuala Lumpur
country: Malaysia
facility: University Malaya Medical Centre
state: Wilayah Persekutuan
Study officials:
affiliation: Chinese University of Hong Kong
name: Mei Sin Chong
role: PRINCIPAL_INVESTIGATOR
References: