Background: There is modest evidence that exercise referral schemes increase physical activity in inactive individuals with chronic health conditions. There is a need to identify additional ways to improve the effects of exercise referral schemes on long-term physical activity.
Objectives: To determine if adding the e-coachER intervention to exercise referral schemes is more clinically effective and cost-effective in increasing physical activity after 1 year than usual exercise referral schemes.
Design: A pragmatic, multicentre, two-arm randomised controlled trial, with a mixed-methods process evaluation and health economic analysis. Participants were allocated in a 1 : 1 ratio to either exercise referral schemes plus e-coachER (intervention) or exercise referral schemes alone (control).
Setting: Patients were referred to exercise referral schemes in Plymouth, Birmingham and Glasgow.
Participants: There were 450 participants aged 16-74 years, with a body mass index of 30-40 kg/m2, with hypertension, prediabetes, type 2 diabetes, lower limb osteoarthritis or a current/recent history of treatment for depression, who were also inactive, contactable via e-mail and internet users.
Intervention: e-coachER was designed to augment exercise referral schemes. Participants received a pedometer and fridge magnet with physical activity recording sheets, and a user guide to access the web-based support in the form of seven 'steps to health'. e-coachER aimed to build the use of behavioural skills (e.g. self-monitoring) while strengthening favourable beliefs in the importance of physical activity, competence, autonomy in physical activity choices and relatedness. All participants were referred to a standard exercise referral scheme.
Primary outcome measure: Minutes of moderate and vigorous physical activity in ≥ 10-minute bouts measured by an accelerometer over 1 week at 12 months, worn ≥ 16 hours per day for ≥ 4 days including ≥ 1 weekend day.
Secondary outcomes: Other accelerometer-derived physical activity measures, self-reported physical activity, exercise referral scheme attendance and EuroQol-5 Dimensions, five-level version, and Hospital Anxiety and Depression Scale scores were collected at 4 and 12 months post randomisation.
Results: Participants had a mean body mass index of 32.6 (standard deviation) 4.4 kg/m2, were referred primarily for weight loss and were mostly confident self-rated information technology users. Primary outcome analysis involving those with usable data showed a weak indicative effect in favour of the intervention group (n = 108) compared with the control group (n = 124); 11.8 weekly minutes of moderate and vigorous physical activity (95% confidence interval -2.1 to 26.0 minutes; p = 0.10). Sixty-four per cent of intervention participants logged on at least once; they gave generally positive feedback on the web-based support. The intervention had no effect on other physical activity outcomes, exercise referral scheme attendance (78% in the control group vs. 75% in the intervention group) or EuroQol-5 Dimensions, five-level version, or Hospital Anxiety and Depression Scale scores, but did enhance a number of process outcomes (i.e. confidence, importance and competence) compared with the control group at 4 months, but not at 12 months. At 12 months, the intervention group incurred an additional mean cost of £439 (95% confidence interval -£182 to £1060) compared with the control group, but generated more quality-adjusted life-years (mean 0.026, 95% confidence interval 0.013 to 0.040), with an incremental cost-effectiveness ratio of an additional £16,885 per quality-adjusted life-year.
Limitations: A significant proportion (46%) of participants were not included in the primary analysis because of study withdrawal and insufficient device wear-time, so the results must be interpreted with caution. The regression model fit for the primary outcome was poor because of the considerable proportion of participants [142/243 (58%)] who recorded no instances of ≥ 10-minute bouts of moderate and vigorous physical activity at 12 months post randomisation.
Future work: The design and rigorous evaluation of cost-effective and scalable ways to increase exercise referral scheme uptake and maintenance of moderate and vigorous physical activity are needed among patients with chronic conditions.
Conclusions: Adding e-coachER to usual exercise referral schemes had only a weak indicative effect on long-term rigorously defined, objectively assessed moderate and vigorous physical activity. The provision of the e-coachER support package led to an additional cost and has a 63% probability of being cost-effective based on the UK threshold of £30,000 per quality-adjusted life-year. The intervention did improve some process outcomes as specified in our logic model.
Trial registration: Current Controlled Trials ISRCTN15644451.
Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 63. See the NIHR Journals Library website for further project information.
Keywords: ACCELEROMETER; COST-EFFECTIVENESS; DEPRESSION; DIABETES; E-HEALTH; EXERCISE; HYPERTENSION; OBESITY; OSTEOARTHRITIS; PRIMARY CARE.
When health-care professionals refer patients with chronic conditions to an exercise referral scheme, the effects on long-term increases in physical activity are limited. We therefore developed the e-coachER support package to add to usual exercise referral schemes and to prompt the use of skills such as self-monitoring and goal-setting. This package was also intended to empower patients to increase their levels of physical activity long term. The seven-step programme was delivered online (via an interactive website). As part of the package, we mailed participants a guide for accessing the online programme, a pedometer and a fridge magnet with a notepad to record physical activity. We aimed to determine whether or not adding the e-coachER support to usual exercise referral schemes resulted in lasting changes in moderate and vigorous physical activity and whether or not it offers good value for money compared with exercise referral schemes alone. A total of 450 inactive individuals were recruited across Plymouth, Birmingham and Glasgow and were referred to an exercise referral scheme for the following participant-reported main reasons: weight loss (50%), low mood (19%), osteoarthritis (12%), type 2 diabetes (10%) and high blood pressure (8%). Half of the individuals were given access to the e-coachER support and the other half were not. All individuals were mailed a wrist-worn movement sensor (accelerometer) to wear for 1 week and a survey to assess other outcomes at the start of the study as well as at 4 and 12 months post randomisation. At the start of the study, the participants were inactive and most had multiple health conditions. The participants had an average body mass index of 33 kg/m2 and an average age of 50 years. Most (83%) were white. Participants with access to e-coachER support were only slightly more active at 12 months than those who did not have access, but we cannot be confident in the findings because we had data from fewer participants than planned. The lack of a clear effect may have been as a result of around one-third of participants not accessing the website, but otherwise there was reasonable engagement. The provision of the e-coachER support package led to an additional cost of £439 per participant over a 12-month period.