The Use of Contextualised Body Data in Cardiac Rehabilitation (CR) (KiCS1)

Liverpool University Hospitals NHS Foundation Trust

Status: Completed

Conditions: Cardiac Rehabilitation

Treatments: Device: Ki monitor with contextualised data feedback; Device: Ki Monitor without feedback

Study type: Interventional

Funder types: Other

Identifiers

NCT05492526

4807

Details and patient eligibility

About

KiCS1 study : Digital health for current hospital- based Cardiac rehabilitation programmes to increase effectiveness and patient outcomes.

Full description

Cardiac rehabilitation (CR) after a heart attack has shown to be more effective than any other medication given after such an event. It is a recommended therapy by NICE. However, only 44% of eligible patients attend rehabilitation and only half of these complete the course. Novel ways to increase uptake and compliance are needed.

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.

Enrollment: 130 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

All patients referred to the cardiac rehab programme will be invited to take part in the study.

Exclusion criteria

1. Individuals using a pacemaker or other internal medical device.
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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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130 participants in 2 patient groups

Usual Cardiac Rehabilitation

Other group

Description:

Patients receive usual care and wear Ki monitor - doesn't receive any feedback during the cardiac rehabilitation period.

Treatment:

Device: Ki Monitor without feedback

Intervention Arm - Usual Cardiac Rehabilitation plus contextualised Data feedback

Experimental group

Description:

Patient receives usual care and also wears Ki monitor and receives contextualised data feedback

Treatment:

Device: Ki monitor with contextualised data feedback