Objectives: To determine if adding the e-coachER intervention to ERS is more effective and cost-effective in increasing PA after one year, compared to usual ERS.
Design: Pragmatic, multicentre 2 arm randomised trial, with mixed methods process evaluation and health economic analysis. Participants were allocated 1:1 to either ERS plus e-coachER (intervention) or ERS alone (control).
Setting: Patients referred to ERS in Plymouth, Birmingham and Glasgow.
Participants: N = 450, aged 16-74 years, with BMI 30-40, hypertension, pre-diabetes, type 2 diabetes, lower limb osteoarthritis, or a current/recent history of treatment for depression; inactive; contactable via email; and an internet user.
Intervention: e-coachER was designed to augment ERS. Participants received a pedometer and fridge magnet with PA recording sheets, and a User Guide to access the web-based support in the form of 7 Steps to Health. e-coachER aimed to build the use of behavioural skills (e.g. self-monitoring) while strengthening favourable beliefs in importance for doing PA, competence, autonomy in PA choices and relatedness. All participants were referred to a standard ERS programme.
Primary outcome measure: Minutes of moderate and vigorous PA (MVPA) in ≥10 min bouts measured by accelerometer over one week at 12 months, worn ≥16 hours per day for ≥4 days including ≥1 weekend day.
Secondary outcomes: Other accelerometer-derived PA measures, self-reported PA, ERS attendance, EQ-5D-5L and HADS were collected at 4 and 12 months.
Results: Participants had a BMI mean (SD) of 32.6 (4.4), were primarily referred for weight loss, and were mostly confident self-rated IT 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); 11.9 weekly minutes MVPA, 95% CI -2.1 to 26.0; p = 0.10. 64% of intervention participants logged on at least once with generally positive feedback on the web-based support. The intervention had no effect on other PA outcomes, ERS attendance (78% v 75% in control and intervention, respectively), EQ-5D-5L or HADS 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, compared to control, the intervention group incurred an additional mean cost of £439 (95% CI £-182, £1060) but generated more mean quality adjusted life years (QALYs); (0.026, 95% CI 0.013, 0.040) with an incremental cost effectiveness ratio of additional £16,885 per QALY.
Limitations: A significant proportion (46%) of participants were not included in the primary analysis, due to study withdrawal, and insufficient device wear time and 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 zero minutes of ≥10 minute bouted MVPA at 12 months.
The design and rigorous evaluation of cost-effective and scalable ways to increase ERS uptake and maintenance of MVPA are needed among patients with chronic conditions.
Conclusion: Adding e-coachER to usual ERS had only a weak indicative effect on long-term rigorously defined, objectively assessed MVPA. 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/QALY. The intervention did improve some process outcomes as specified in our Logic Model.
Study registration: ISRCTN15644451
Funding details: NIHR HTA 13/25/20
|Journal||Health Technology Assessment|
|Publication status||Acceptance date - 27 Nov 2019|