Ignite Creation Date:
2024-05-06 @ 4:05 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04862351
Status:
COMPLETED
Last Update Posted:
2024-04-17
First Post:
2021-04-07
Brief Title:
Effectiveness of TechCR Among CHD Patients
Sponsor:
Chinese University of Hong Kong
Organization:
Chinese University of Hong Kong
Study Overview
Official Title:
Effectiveness of Technology-assisted Interventions in Hybrid Cardiac Rehabilitation TechCR Among Coronary Heart Disease Patients
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TechCR
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 11 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 audiovideo-conferencing follow-up Week 1 to Week 12 The outcome measures include Socio-demographic and Clinical Data Banduras 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 260 with a p value 005 will be consider significant of the result
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 audiovideo-conferencing follow-up Week 1 to Week 12 The outcome measures include Socio-demographic and Clinical Data Banduras 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 260 with a p value 005 will be consider significant of the result
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None