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

Cardiovascular Diseases Clinical Trial

— ACTIVE-CR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05605015
• Other study ID #: ACTIVE-CR-V1
• Status: Recruiting
• Phase: N/A
• Start date: May 5, 2023
• Est. completion date: December 2023

Study information

• Verified date: May 2023
• Source: University of Bath
• Contact: Daniella Springett
• Phone: +441225383270
• Email: ds850[@]bath.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2023
• Est. primary completion date: August 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria: Patients will be recruited in line with British Association for Cardiovascular Prevention and Rehabilitation (BACPR) guidelines, which states that the following priority patient groups shall be offered CR irrespective of age, sex, ethnic

group, and clinical condition:

• 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: Patients who were not referred/deemed eligible for CR (assessed by clinical care team)
• 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

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

Behavioral:
• 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

Locations

Country	Name	City	State
United Kingdom	University of Bath	Bath

Sponsors (2)

Lead Sponsor	Collaborator
University of Bath	Royal United Hospitals Bath NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility: study recruitment	Assess recruitment rates, defined as the proportion of eligible patients who accept the invitation to participate in the study.	6-weeks
Primary	Feasibility: retention	Examine retention and adherence: defined as the proportion of participants who complete the study	6-weeks
Primary	Feasibility: adherence	Examine adherence: defined as the proportion of online trainer sessions completed and platform usage	6-weeks
Primary	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	Seven day physical activity measurement using a research grade device	A wrist worn physical activity monitor will be used to quantify the following physical activity measures derived from energy expenditure: sedentary time, and light, moderate, vigorous and very vigorous intensities of activity	6-weeks
Secondary	Weight	Kilograms	6-weeks
Secondary	Height	Centimetres	6-weeks
Secondary	Waist circumference	Centimetres	6-weeks
Secondary	Systolic and diastolic blood pressure	Measured in millimetres of mercury (mmHg)	6-weeks
Secondary	Cholesterol levels (Low-density lipoproteins, high-density lipoproteins, total cholesterol)	Measured in millimoles per litre of blood	6-weeks
Secondary	Triglyceride levels	Measured in millimoles per litre of blood	6-weeks
Secondary	Functional capacity	Measured by the 6-minute walk test (metres)	6-weeks
Secondary	Hospital Anxiety and Depression Scale	Score 0-7 represents "normal," 8-10 "mild," 11-14 "moderate," and 15-21 "severe."	6-weeks
Secondary	Dartmouth COOP Functional Assessment Charts	Overall quality of life, physical function, social function, pain. 9 questions, each with answers ranging from 1-5. Possible scores 9-45. The higher the score, the worse the outcome	6-weeks
Secondary	Behavioural Regulation in Exercise Questionnaire-3		6-weeks
Secondary	The Exercise Self-Efficacy Scale	Rating of participant's degree of confidence to 18 statements by recording a number from 0 to 100% for each one. The higher the score, the higher the degree of confidence.	6-weeks
Secondary	International Physical Activity Questionnaire	Self-report measure for physical activity	6-weeks
Secondary	Health Care Climate Questionnaire (short-form)	6 items, used to assess participant's perceptions of the degree to which their trainer was autonomy supportive. The scale ranges from 1-7 (scores therefore range from 6-42). The higher the score, the better the participant's perception of support from the trainer	6-weeks