Effectiveness of TechCR Among CHD Patients

NCT ID: NCT04862351

Last Updated: 2024-04-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-26
• Study Completion Date: 2023-10-31

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.

Conditions

Coronary Heart Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

TecHCR

12 weeks Hybrid between supervised exercise training and video call sessions Educational videos Dietary and exercise log

Group Type: EXPERIMENTAL

exercise training for TechCR

Intervention Type: BEHAVIORAL

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

audio/video conference

Intervention Type: BEHAVIORAL

weekly audio/video conference

educational video

Intervention Type: BEHAVIORAL

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

Daily log

Intervention Type: BEHAVIORAL

daily dietary and exercise log

Centre-based

12 weeks usual care provided by the centre-based, outpatient cardiac rehabilitation clinic Dietary and exercise log

Group Type: OTHER

Daily log

Intervention Type: BEHAVIORAL

daily dietary and exercise log

exercise training for centre-based

Intervention Type: BEHAVIORAL

6 times of supervised exercise training

Interventions

exercise training for TechCR

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

Intervention Type: BEHAVIORAL

audio/video conference

weekly audio/video conference

Intervention Type: BEHAVIORAL

educational video

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

Intervention Type: BEHAVIORAL

Daily log

daily dietary and exercise log

Intervention Type: BEHAVIORAL

exercise training for centre-based

6 times of supervised exercise training

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Mei Sin CHONG

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mei Sin Chong

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

Locations

University Malaya Medical Centre

Kuala Lumpur, Kuala Lumpur, Malaysia

Countries

Malaysia

References

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.

Reference Type: DERIVED

PMID: 37355035 (View on PubMed)

Other Identifiers

2020.621

Identifier Type: -

Identifier Source: org_study_id