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

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.

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

Study Overview

• Status: Completed
• Conditions: Cardiac Rehabilitation
• Intervention / Treatment: Device: Ki Monitor without feedback; Device: Ki monitor with contextualised data feedback

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 130
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Liverpool, United Kingdom, L78xp
    • Liverpool University Hospital NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life measured using the Dartmouth Coop	Participants completed a questionnaire at the start and end of the cardiac rehabilitation program.	6-8 weeks
Anxiety and depression score measured using Hospital Anxiety and depression scale (HADS)	Participants completed a questionnaire at the start and end of the cardiac rehabilitation program.	6-8 weeks
Body mass index measured using height and weight and combined to report in kg/m2	Measured at the beginning and end of Cardiac rehabilitation programme	6-8 weeks
Blood pressure measured and reported in mmHg	Measured before and after exercise tests at the beginning and end of the cardiac rehabilitation programme	6- 8 weeks
Blood Glucose measured and reported in mmol/L	Measured at the beginning and end of Cardiac rehabilitation programme where appropriate	6-8 weeks

Collaborators and Investigators

• Sponsor: Liverpool University Hospitals NHS Foundation Trust
• Collaborators: KiActiv
• Investigators: Principal Investigator: Micheal Fisher, Liverpool University Hospitals NHS Trust

Study record dates

Study Major Dates

• Study Start (Actual): May 7, 2021
• Primary Completion (Actual): November 11, 2022
• Study Completion (Actual): May 23, 2023

Study Registration Dates

• First Submitted: July 20, 2022
• First Submitted That Met QC Criteria: August 5, 2022
• First Posted (Actual): August 8, 2022

Study Record Updates

• Last Update Posted (Actual): August 1, 2023
• Last Update Submitted That Met QC Criteria: July 31, 2023
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Exercise; Heart failure; STEMI; Angina; CABG; Physical activity; Digital Health; NSTEMI; Myocardial Infarction; Cardiac Rehabilitation
• Other Study ID Numbers: 4807

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No