Clinical trial NCT05605015: Wearable Technology for Personalised Physical Activity Feedback in Cardiac Patients: a Feasibility Study
Official title: Wearable Technology for Personalised Physical Activity Feedback in Cardiac Patients: a Feasibility
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Cardiovascular Diseases
Lead sponsor: University of Bath
Sponsor class: OTHER
Collaborators: name: Royal United Hospitals Bath NHS Foundation Trust
First posted: 2022-11-03
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility: study recruitment
timeFrame: 6-weeks
measure: Feasibility: retention
timeFrame: 6-weeks
measure: Feasibility: adherence
timeFrame: 6-weeks
measure: Feasibility: acceptability
timeFrame: 6-weeks
Secondary outcomes:
measure: Seven day physical activity measurement using a research grade device
timeFrame: 6-weeks
measure: Weight
timeFrame: 6-weeks
measure: Height
timeFrame: 6-weeks
measure: Waist circumference
timeFrame: 6-weeks
measure: Systolic and diastolic blood pressure
timeFrame: 6-weeks
measure: Cholesterol levels (Low-density lipoproteins, high-density lipoproteins, total cholesterol)
timeFrame: 6-weeks
measure: Triglyceride levels
timeFrame: 6-weeks
measure: Functional capacity
timeFrame: 6-weeks
measure: Hospital Anxiety and Depression Scale
timeFrame: 6-weeks
measure: Dartmouth COOP Functional Assessment Charts
timeFrame: 6-weeks
measure: Behavioural Regulation in Exercise Questionnaire-3
timeFrame: 6-weeks
measure: The Exercise Self-Efficacy Scale
timeFrame: 6-weeks
measure: International Physical Activity Questionnaire
timeFrame: 6-weeks
measure: Health Care Climate Questionnaire (short-form)
timeFrame: 6-weeks
Other outcomes:
Locations:
city: Bath
country: United Kingdom
facility: University of Bath
Study officials:
affiliation: University of Bath
name: Oliver Peacock, PhD
role: PRINCIPAL_INVESTIGATOR
References: