Title: A multi-centred RCT of an augmented exercise referral scheme using web-based behavioural support in individuals with metabolic, musculo-skeletal and mental health conditions
Funder: Department of Health and Social Care

Abstract: The NHS routinely offers a service in which a doctor or health care professional refers a patient, with a medical condition that can benefit from exercise, to an exercise referral scheme (ERS). Schemes involve a supervised programme of both aerobic and resistance exercise tailored to individual needs, at an exercise facility or physical activity (PA) counselling support. However, uptake and adherence can be low, and there is an absence of rigorous data to show long-term change in physical activity. We have had extensive input from patients and ERS professionals to suggest that longer-term motivational support is needed beyond the traditional 10-12 week programme. There is rapidly growing interest in new technologies to support health behaviour change, including websites, text messaging, and apps on smart phones. Such support engages a good proportion of patients and provides valued and effective support. The Lifeguide website has provided support that has been appreciated by patients to self-manage various medical conditions, and health behaviours (Williams et al, 2013; Yardley et al, 2010; 2011) but has not been used to support patients concurrently attending an ERS. We propose to refine an existing form of interactive internet-based support (Lifeguide) into something called e-coach which can help patients with common long-term medical conditions, namely obesity, hypertension, type 2 diabetes, osteoarthritis and depression, to be more likely to attend an ERS and help with long-term motivation to do PA and improve health related quality of life. Our e-coach intervention will provide consistent and coherent support that seeks to empower individuals through increased confidence to be physically active, and to be more proactive in self-managing their condition with PA, with types of PA that are most sustainable. The proposed research will compare standard ERS with ERS plus the e-coach intervention, introduced to patients at the point of referral and remaining accessible during and beyond the usual ERS. At the point of referral a nurse will randomly allocate patients who meet certain criteria to receive either usual ERS or ERS plus e-coach. Only those in the intervention will be given log-in details to access e-coach and given facilitator and technician support to use it. The ERS will provide usual support (i.e. structured exercise or PA counselling) to all participants but e-coach will give additional support that is expected to help patients to remain physically active after 12 months. Research will be conducted in ERS in Glasgow, Devon/Cornwall and West Midlands. As our main outcome, we plan to examine if the two groups differ in the proportion of patients who are meeting public health guidelines of at least 150 minutes of moderate or vigorous PA, using the most advanced objective measurement by motion sensors, at 12 months. A range of PA, health-related quality of life, and resource use outcomes will also be assessed at 4 and 12 months to compare the groups. Economic analysis will consider the long-term benefits for the NHS. Process evaluation will examine use of the web-based support and its effects on outcome among the five medical groups, though we expect some patients will have more than one condition.

Lay abstract: Design: Multi-centre individually randomised two arm trial with internal pilot trial. Setting: Patients identified routinely or by record search in primary care practices involved in an exercise referral scheme (ERS) in Glasgow, Devon/Cornwall or West Midlands. Suitable patients interested in ERS to be randomly assigned (1:1) to usual ERS (control) or usual ERS plus an e-coach intervention. Target population: Inactive individuals with experience of the chronic conditions of obesity, hypertension, type 2 diabetes, osteoarthritis, or depression for whom NICE recommends exercise. Inclusion criteria: Adults aged 16-74 years meeting existing ERS eligibility criteria. Health technology assessed: Standard ERS involves tailored programmes at an exercise facility or counselling support, led by an exercise practitioner, over 10-12 weeks (see BHF Report, 2010; Pavey et al, 2011). E-coach intervention will augment usual ERS by providing on-line and interactive evidence-based behaviour change support, and both facilitator support to engage with the Lifeguide platform (https://www.lifeguideonline.org/) and technical support. Lifeguide will be specifically adapted to support uptake to ERS and long-term maintenance of physical activity (PA), for patients with the targeted conditions. Measurement of costs and outcomes: Achievement of objectively assessed 150 minutes of moderate/vigorous PA per week at 12 months (primary outcome). Secondary outcomes include measures of PA (self-report and accelerometer), ERS uptake and adherence, health-related quality of life (EQ-5D-5L & SF-36v2), and within-trial resource use, at 4 and 12 months. Economic analysis will estimate trial arm differences in mean costs, and incremental cost-effectiveness ratios per QALY. Beyond trial modelling, a Markov decision model will be used to examine the impact of PA on lifetime risk of developing CHD, stroke and other medical conditions. Process evaluation: Mixed methods to assess experiences of participants, e-coach facilitators, and health and exercise professionals, plus use of the web-based support and its mediating effects on outcomes. The role of psycho-social variables will also be assessed as mediators. Sample size: Estimated 700 per group to detect a 10% increase with intervention compared to 43% of control participants achieving the primary outcome at 12 months (Pavey et al, 2012), assuming a loss to follow up of less than 20% (Murphy et al. 2011; Pavey et al, 2012) and allowing for clustering (mean ICC 0.000 to 0.006 estimated from Jolly et al, 2010 trial). Our exploratory modelling indicates that a change of least 10% is required for the intervention to achieve an incremental cost effectiveness ratio of <£20,000/QALY. Internal pilot: After 3 months (and recruitment of 180 participants over 3 sites) we will assess the evidence (with the funders and Trial Steering Committee) to support progression (with set rules) to the main trial based on: (1) feasibility to recruit a further 1220 (during the remaining 12 month recruitment window); (2) initial intervention participant engagement with e-coach. Start date: 1/1/2015 Project timetable: finalise intervention development (-6 to 0 months); set up / intervention training (0-6 months); internal pilot (7-9 months); full trial recruitment (10-21 months); 4 month follow-up (11-25 months); 12 month follow up (19-33 months); data analysis and report writing (33-37 months). Total trial: 37 months.

Research activity codes: 7.1 INDIVIDUAL CARE NEEDS
Health categories: GENERIC HEALTH RELEVANCE