Andrew Farmer , DM (Oxon) , 1 , Veronika Williams , PhD 1 , Carmelo Velardo , PhD 2 , Syed Ahmar Shah , DPhil (Oxon) 2 , Ly-Mee Yu , DPhil (Oxon) 1 , Heather Rutter , DipHE 1 , Louise Jones , DPhil (Oxon) 1 , Nicola Williams , MSc 1 , Carl Heneghan , DPhil (Oxon) 1 , Jonathan Price , DPhil (Oxon) 3 , Maxine Hardinge , FRCP 4 , Lionel Tarassenko , DPhil (Oxon) 2
03 May 2017
We conducted a randomized controlled trial of a digital health system supporting clinical care through monitoring and self-management support in community-based patients with moderate to very severe chronic obstructive pulmonary disease (COPD).
The aim of this study was to determine the efficacy of a fully automated Internet-linked, tablet computer-based system of monitoring and self-management support (EDGE‚ sElf-management anD support proGrammE) in improving quality of life and clinical outcomes.
We compared daily use of EDGE with usual care for 12 months. The primary outcome was COPD-specific health status measured with the St George’s Respiratory Questionnaire for COPD (SGRQ-C).
A total of 166 patients were randomized (110 EDGE, 56 usual care). All patients were included in an intention to treat analysis. The estimated difference in SGRQ-C at 12 months (EDGE−usual care) was −1.7 with a 95% CI of −6.6 to 3.2 ( P=.49). The relative risk of hospital admission for EDGE was 0.83 (0.56-1.24, P=.37) compared with usual care. Generic health status (EQ-5D, EuroQol 5-Dimension Questionnaire) between the groups differed significantly with better health status for the EDGE group (0.076, 95% CI 0.008-0.14, P=.03). The median number of visits to general practitioners for EDGE versus usual care were 4 versus 5.5 ( P=.06) and to practice nurses were 1.5 versus 2.5 ( P=.03), respectively.
The EDGE clinical trial does not provide evidence for an effect on COPD-specific health status in comparison with usual care, despite uptake of the intervention. However, there appears to be an overall benefit in generic health status; and the effect sizes for improved depression score, reductions in hospital admissions, and general practice visits warrants further evaluation and could make an important contribution to supporting people with COPD.