The Use of Contextualised Body Data in Cardiac Rehabilitation (CR)
NCT ID: NCT05492526
Last Updated: 2023-08-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
130 participants
INTERVENTIONAL
2021-05-07
2023-05-23
Brief Summary
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Detailed Description
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In this study, calorie burn and physical activity data will be collected using a validated, CE marked physical activity monitor, herein referred to as Ki monitor. Data can be uploaded to an online behaviour change platform that incorporates personalised feedback in the context of their bespoke requirements for CR to empower people to self-care at home using their personal everyday physical activity. This can be closely monitored and support can be given on the contextualised feedback by healthcare professionals. A small pilot study has been carried out to establish wearability of a physical activity monitor in a CR cohort, which has demonstrated a high level of acceptability.
We now wish to extend this pilot to a randomised study designed to test the effectiveness of using contextualised body data to influence physical activity in a free-living environment amongst patients undergoing CR, based on the current ACPICR standards for Daily Activity and At-home Training. All patients referred for CR will be invited to take part. These will be randomised to the usual care (UC) group or the contextualised data feedback (CDF) group. Both groups will wear the Ki monitor for eight weeks. The UC group will receive usual care, the CDF group will receive usual care with the addition of contextualised feedback on their activities based on the physical activity data.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Usual Cardiac Rehabilitation
Patients receive usual care and wear Ki monitor - doesn't receive any feedback during the cardiac rehabilitation period.
Ki Monitor without feedback
Physical activity Monitor - No feedback
Intervention Arm - Usual Cardiac Rehabilitation plus contextualised Data feedback
Patient receives usual care and also wears Ki monitor and receives contextualised data feedback
Ki monitor with contextualised data feedback
Physical activity monitor and feedback
Interventions
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Ki Monitor without feedback
Physical activity Monitor - No feedback
Ki monitor with contextualised data feedback
Physical activity monitor and feedback
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
2. Unable to access a computer or tablet with internet access to view the online platform.
3. Unable to access a smartphone or tablet with bluetooth connectivity and internet access to upload data from the activity monitor.
4. Unwillingness to take part.
ALL
No
Sponsors
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KiActiv
UNKNOWN
Liverpool University Hospitals NHS Foundation Trust
OTHER_GOV
Responsible Party
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Principal Investigators
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Micheal Fisher
Role: PRINCIPAL_INVESTIGATOR
Liverpool University Hospitals NHS Trust
Locations
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Liverpool University Hospital NHS Foundation Trust
Liverpool, , United Kingdom
Countries
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Other Identifiers
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4807
Identifier Type: -
Identifier Source: org_study_id
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