AzTrials
AzTrials

Coronary Heart DiseaseTechCRNCT04862351

Effectiveness of TechCR Among CHD Patients

A study testing exercise training for TechCR, audio/video conference and educational video in people with Coronary Heart Disease, run by Chinese University of Hong Kong at 1 site in Malaysia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Heart Disease
What is being tested?
exercise training for TechCR, audio/video conference and educational video
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
1 siteMalaysia
Study dates
26 Feb 2021to 31 Oct 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Malaysia1 site
  • University Malaya Medical Centre

    Kuala Lumpur, Kuala Lumpur

Other trials in Malaysia

About this study

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

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.

Read the 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.

Being tested
exercise training for TechCR, audio/video conference, educational video, Daily log, exercise training for centre-based
Keywords
technology-assisted interventions, hybrid cardiac rehabilitation, coronary heart disease
Medical subject headings
Coronary Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • exercise training for TechCRBehavioural

    3 times of supervised exercise training at the centre-based, outpatient cardiac rehabilitation clinic

  • audio/video conferenceBehavioural

    weekly audio/video conference

  • educational videoBehavioural

    weekly for 6 weeks, duration of video about 10-15 minutes

  • Daily logBehavioural

    daily dietary and exercise log

  • exercise training for centre-basedBehavioural

    6 times of supervised exercise training

Study groups in NCT04862351
Study groupRoleWhat they receive
TecHCRExperimental12 weeks Hybrid between supervised exercise training and video call sessions Educational videos Dietary and exercise log
Receives: Behavioral: exercise training for TechCR; Behavioral: audio/video conference; Behavioral: educational video; Behavioral: Daily log
Centre-basedOther12 weeks usual care provided by the centre-based, outpatient cardiac rehabilitation clinic Dietary and exercise log
Receives: Behavioral: Daily log; Behavioral: exercise training for centre-based

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: Baseline (T0) - at 0 week, before initiation of interventions

  2. 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)

    Measured: post intervention (T1) - at 12 weeks after initiation of interventions

  3. 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)

    Measured: 6-month post intervention (T2) - at 36 weeks after initiation of interventions

Secondary outcomes (18)
  1. behavioural outcomes (Health-promoting Lifestyle Profile II)

    Using Health-promoting lifestyle Profile II to determine the effects of TecHCR on health promoting behaviours

    Measured: Baseline (T0) - at 0 week, before initiation of interventions

  2. behavioural outcomes (Health-promoting Lifestyle Profile II)

    Using Health-promoting lifestyle Profile II to determine the effects of TecHCR on health promoting behaviours

    Measured: post intervention (T1) - at 12 weeks after initiation of interventions

  3. behavioural outcomes (Health-promoting Lifestyle Profile II)

    Using Health-promoting lifestyle Profile II to determine the effects of TecHCR on health promoting behaviours

    Measured: 6-month post intervention (T2) - at 36 weeks after initiation of interventions

  4. psychological outcomes (Hospital Anxiety and Depression Scale)

    Using Hospital Anxiety and Depression Scale to determine the effects of TecHCR on anxiety and depression

    Measured: Baseline (T0) - at 0 week, before initiation of interventions

  5. psychological outcomes (Hospital Anxiety and Depression Scale)

    Using Hospital Anxiety and Depression Scale to determine the effects of TecHCR on anxiety and depression

    Measured: post intervention (T1) - at 12 weeks after initiation of interventions

  6. psychological outcomes (Hospital Anxiety and Depression Scale)

    Using Hospital Anxiety and Depression Scale to determine the effects of TecHCR on anxiety and depression

    Measured: 6-month post intervention (T2) - at 36 weeks after initiation of interventions

  7. 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)

    Measured: Baseline (T0) - at 0 week, before initiation of interventions

  8. 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)

    Measured: post intervention (T1) - at 12 weeks after initiation of interventions

  9. 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)

    Measured: 6-month post intervention (T2) - at 36 weeks after initiation of interventions

  10. systolic and diastolic blood pressure (using blood pressure monitoring device)

    to determine the effects of TecHCR on systolic and diastolic blood pressure

    Measured: Baseline (T0) - at 0 week, before initiation of interventions

  11. systolic and diastolic blood pressure (using blood pressure monitoring device)

    to determine the effects of TecHCR on systolic and diastolic blood pressure

    Measured: post intervention (T1) - at 12 weeks after initiation of interventions

  12. systolic and diastolic blood pressure (using blood pressure monitoring device)

    to determine the effects of TecHCR on systolic and diastolic blood pressure

    Measured: 6-month post intervention (T2) - at 36 weeks after initiation of interventions

  13. Body Mass Index (BMI) (weight in kilogrammes*height in metres^2)

    to determine the effects of TecHCR on BMI

    Measured: Baseline (T0) - at 0 week, before initiation of interventions

  14. Body Mass Index (BMI) (weight in kilogrammes*height in metres^2)

    to determine the effects of TecHCR on BMI

    Measured: post intervention (T1) - at 12 weeks after initiation of interventions

  15. Body Mass Index (BMI) (weight in kilogrammes*height in metres^2)

    to determine the effects of TecHCR on BMI

    Measured: 6-month post intervention (T2) - at 36 weeks after initiation of interventions

  16. Waist circumference (measured by measuring tape in centimetres)

    to determine the effects of TecHCR on waist circumference

    Measured: Baseline (T0) - at 0 week, before initiation of interventions

  17. Waist circumference (measured by measuring tape in centimetres)

    to determine the effects of TecHCR on waist circumference

    Measured: post intervention (T1) - at 12 weeks after initiation of interventions

  18. Waist circumference (measured by measuring tape in centimetres)

    to determine the effects of TecHCR on waist circumference

    Measured: 6-month post intervention (T2) - at 36 weeks after initiation of interventions

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Apr 2021
  2. Study start26 Feb 2021
  3. Primary completion31 Oct 2023
  4. Study completion31 Oct 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
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 blind
Who is masked
Outcomes assessor
Enrolment
160 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04862351
Sponsor's protocol ID
2020.621
Acronym
TechCR
Status last verified
Apr 2024
First submitted
7 Apr 2021
Last updated
17 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Chong MS, Sit JWH, Choi KC, Suhaimi A, Jiang Y, Chair SY. The Effects of a Technology-Assisted Hybrid Cardiac Rehabilitation (TecHCR) Program for Adults With Coronary Heart Disease: A Randomized Controlled Trial. Worldviews Evid Based Nurs. 2025 Dec;22(6):e70092. doi: 10.1111/wvn.70092.

    PubMed 41457512
  • Chong MS, Sit JWH, Choi KC, Suhaimi A, Chair SY. A Theory-Based, Technology-Assisted Intervention in a Hybrid Cardiac Rehabilitation Program for Patients with Coronary Heart Disease: A Feasibility Study. Asian Nurs Res (Korean Soc Nurs Sci). 2023 Aug;17(3):180-190. doi: 10.1016/j.anr.2023.06.004. Epub 2023 Jun 22.

    PubMed 37355035

Questions about this trial

What is this clinical trial studying?

A study testing exercise training for TechCR, audio/video conference and educational video in people with Coronary Heart Disease, run by Chinese University of Hong Kong at 1 site in Malaysia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

self-efficacy related to exercise (Bandura's Exercise Self-efficacy) (time frame: Baseline (T0) - at 0 week, before initiation of interventions). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04862351, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2024.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in