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

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

Detailed Description
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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.

Official Title
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Using Body Data for the Purpose of Contextualised Feedback to Enable Established Physical Activity Guidelines to be Delivered in a Free- Living Environment as Part of a Comprehensive Cardiac Rehabilitation Programme.

Conditions
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Cardiac Rehabilitation

Intervention / Treatment
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* Device: Ki Monitor without feedback
* Device: Ki monitor with contextualised data feedback


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients referred to the cardiac rehab programme will be invited to take part in the study. Exclusion Criteria: Individuals using a pacemaker or other internal medical device. Unable to access a computer or tablet with internet access to view the online platform. Unable to access a smartphone or tablet with bluetooth connectivity and internet access to upload data from the activity monitor. Unwillingness to take part.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective, randomised, open -label study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Usual Cardiac Rehabilitation<br>Patients receive usual care and wear Ki monitor - doesn't receive any feedback during the cardiac rehabilitation period. | Device: Ki Monitor without feedback<br>* Physical activity Monitor - No feedback<br>|
| Experimental: Intervention Arm - Usual Cardiac Rehabilitation plus contextualised Data feedback<br>Patient receives usual care and also wears Ki monitor and receives contextualised data feedback | Device: Ki monitor with contextualised data feedback<br>* Physical activity monitor and feedback<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Achieving the ACPICR standards for physical activity in a free-living environment objectively measured using the Ki monitor | Objective measurement using Ki monitor. | 6 - 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exercise test result. | Incremental shuttle walk test or 6 minute walking test, as appropriate | 6-8 weeks | 
| Total calories burned | Objectively measured using the Ki monitor | 6-8 weeks | 
| Completion of cardiac rehabilitation programme | Number of participants completed full cardiac rehabilitation programme. | 6-8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CABG, Cardiac Rehabilitation, Myocardial Infarction, NSTEMI, STEMI, Angina, Exercise, Physical activity, Heart failure, Digital Health