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

NCT05605015 | Completed Early Phase 1

• 1 other identifier: ACTIVE-CR-V1
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Diseases

Outcome Measures

Primary Outcomes (4)

• Feasibility: study recruitment

  Assess recruitment rates, defined as the proportion of eligible patients who accept the invitation to participate in the study.

  6-weeks

• Feasibility: retention

  Examine retention and adherence: defined as the proportion of participants who complete the study

  6-weeks

• Feasibility: adherence

  Examine adherence: defined as the proportion of online trainer sessions completed and platform usage

  6-weeks

• Feasibility: acceptability

  Explore the acceptability of the ACTIVE-CR intervention (in terms of affective attitude, burden, perceived effectiveness, ethicality, intervention coherence, opportunity costs, and self-efficacy) using The Theoretical Framework of Acceptability (TFA) Questionnaire

  6-weeks

Secondary Outcomes (14)

• Seven day physical activity measurement using a research grade device

  6-weeks

• Weight

  6-weeks

• Height

  6-weeks

• Waist circumference

  6-weeks

• Systolic and diastolic blood pressure

  6-weeks

Study Arms (2)

ACTIVE-CR INTERVENTION

EXPERIMENTAL

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.

Behavioral: ACTIVE-CR

CONTROL

NO INTERVENTION

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).

Interventions

ACTIVE-CR 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

ACTIVE-CR INTERVENTION

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Bath: lead
• Royal United Hospitals Bath NHS Foundation Trust: collaborator

Study Sites (1)

University of Bath

Bath, BA2 7AY, United Kingdom

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• Oliver Peacock, PhD

  University of Bath

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 19, 2022
• First Posted: November 3, 2022
• Study Start: May 5, 2023
• Primary Completion: March 31, 2024
• Study Completion: December 31, 2024
• Last Updated: February 5, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)