Wearable Technology for Personalised Physical Activity Feedback in Cardiac Patients: a Feasibility Study

NCT ID: NCT05605015

Last Updated: 2025-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-05
• Study Completion Date: 2024-12-31

Brief Summary

Cardiac rehabilitation (CR) is a comprehensive, long-term secondary care programme offered to individuals after a heart attack to aid recovery and prevent further illness. If properly implemented, CR is highly effective at reducing cardiac mortality, re-event, and re-admissions. Despite the well-established benefits, less than 50% of eligible UK patients enrol on a CR program. Among those who do begin CR in the UK, drop-out rates of 12-55% have been reported. If the take up of CR were increased to 65% it would reduce readmissions by a third and save approximately £100 million per year.

Physical activity (PA) is the cornerstone of CR. With recent advances in wearable activity monitors, accurate and objective assessment of free-living PA is now possible. It is increasingly apparent that the health benefits of PA can be achieved in many ways, and multiple dimensions (or aspects) of PA are independently important. The most sophisticated wearable devices can be used to capture these different dimensions and provide a more comprehensive evaluation of free-living PA - enabling patients to understand their individual PA in the context of guidelines - and offering more behavioural options and personalised advice.

In prior work, the investigators have developed a digital system for patients to self-manage their PA. This system comprises a wearable wrist-mounted accelerometer, bespoke digital platform, plus remote virtual support. The digital system has been customised for CR based on qualitative research in cardiac patients and practitioners - who found PA feedback to be understandable and motivating - and a route to address barrier to taking part in CR. This study aims to examine the feasibility of delivering a 6-week trial of a remote, technology-enabled physical activity intervention to patients who were unable to take up or dropped out of CR in the last 12 months.

Detailed Description

Current provision of cardiac rehabilitation in the UK is only taken up by <50% of eligible patients, despite the importance of attending for managing symptoms, reducing hospital readmissions and mortality, and improving quality of life. Widely reported factors related to non-attendance include employment commitments, difficulties with transport, lack of time, distance to travel and embarrassment related to attending rehabilitation. The use of home-based programmes permits greater flexibility of CR delivery, as patients are able to complete their programme at a place and time that suit them, as well as increasing access for those who are unable to travel or do not live in close proximity to face-to-face classes. However, current home-based approaches are lacking in objective monitoring of patients and strategies to increase physical activity are limited, despite it being a core component of CR. It is increasingly apparent that the health benefits of physical activity can be achieved in many ways, and multiple dimensions (or aspects) of physical activity are independently important.

Our past research shows that many people misjudge their physical activity status because they do not have access to accurate personalised information. With recent advances in wearable activity monitors, accurate and objective assessment of daily physical activity is possible. The most sophisticated wearable devices can now be used to capture multiple dimensions of physical activity and thus improve the depth and quality of feedback provided to individuals. To date, technology-based physical activity interventions in CR have primarily targeted unidimensional physical activity outcomes, such as step counts and sedentary behaviour.

Multidimensional feedback provides greater awareness, insight, and a more complete understanding of personal physical activity; enabling individuals to take greater responsibility for managing their behaviour and in the context of physical activity guidelines. In addition, a multidimensional approach offers more behavioural options and personalised advice.

Therefore, this study aims to examine the feasibility of delivering a 6-week trial of a remote, technology-enabled physical activity intervention to patients who were unable to take up or dropped out of CR. This study addresses several further shortcomings of previous research in this area: 1) the lack of grounding in psychological behaviour change theory, 2) the lack of objective monitoring for physical activity in CR, and 3) the need for support from practitioners and/or trainers to facilitate physical activity behaviour change.

Conditions

Cardiovascular Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ACTIVE-CR INTERVENTION

Participants will complete a 6-week remote, technology-based physical activity intervention named ACTIVE-CR, in which they will be required to wear a wrist worn monitor to measure daily physical activity. Participants will be able to view their physical activity feedback on a web-based platform and will receive three online trainer sessions across the 6 weeks to help them to understand and interpret their data.

Group Type: EXPERIMENTAL

ACTIVE-CR

Intervention Type: BEHAVIORAL

The ACTIVE-CR intervention comprises three key components: a wrist-worn physical activity monitor, a web-based platform providing physical activity feedback, and three autonomy supportive online trainer sessions. Each component is grounded by multiple established behaviour change techniques consistent with the behaviour change taxonomy developed by Michie et al. (2013). The barriers to physical activity were identified in our previous work and are consistent with previous literature

CONTROL

Participants in the control group will receive usual care from their healthcare team (if relevant) and will be invited to have an assessment at baseline and 6-weeks. Control participants will not receive any form of intervention. At the end of the study, control participants will receive a summary of their physical activity data measured at baseline and 6-weeks (in a booklet format with guidance on how to interpret and use the information).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

ACTIVE-CR

The ACTIVE-CR intervention comprises three key components: a wrist-worn physical activity monitor, a web-based platform providing physical activity feedback, and three autonomy supportive online trainer sessions. Each component is grounded by multiple established behaviour change techniques consistent with the behaviour change taxonomy developed by Michie et al. (2013). The barriers to physical activity were identified in our previous work and are consistent with previous literature

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Acute coronary syndrome
• Coronary revascularisation
• Heart failure

Other patient groups known to benefit:

• Stable angina
• Peripheral arterial disease
• Post-cerebrovascular event
• Post-implantation of cardiac defibrillators and resynchronisation devices
• Post-heart valve repair/replacement
• Post-heart transplantation and ventricular assist devices
• Adult congenital heart disease

Participants must also:

• Have access to a smart phone or tablet and the internet
• Have declined or dropped out of CR in the last 12 months

Exclusion Criteria

• No access to the internet and/or a smart phone
• Individuals who have completed CR in the last 12 months
• Unable to read English
• Unable to understand written or verbal information

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Royal United Hospitals Bath NHS Foundation Trust

OTHER

Sponsor Role: collaborator

University of Bath

OTHER

Sponsor Role: lead

Responsible Party

Daniella Springett

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Oliver Peacock, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Bath

Locations

University of Bath

Bath, , United Kingdom

Countries

United Kingdom

Other Identifiers

ACTIVE-CR-V1

Identifier Type: -

Identifier Source: org_study_id