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Randomized Controlled Trial
. 2017 May 3;19(5):e144.
doi: 10.2196/jmir.7116.

Self-Management Support Using a Digital Health System Compared With Usual Care for Chronic Obstructive Pulmonary Disease: Randomized Controlled Trial

Andrew Farmer  1 , Veronika Williams  1 , Carmelo Velardo  2 , Syed Ahmar Shah  2 , Ly-Mee Yu  1 , Heather Rutter  1 , Louise Jones  1 , Nicola Williams  1 , Carl Heneghan  1 , Jonathan Price  3 , Maxine Hardinge  4 , Lionel Tarassenko  2
Affiliations
Randomized Controlled Trial

Self-Management Support Using a Digital Health System Compared With Usual Care for Chronic Obstructive Pulmonary Disease: Randomized Controlled Trial

Andrew Farmer et al. J Med Internet Res. .

Abstract

Background: 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).

Objective: 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.

Methods: 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).

Results: 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.

Conclusions: 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.

Trial registration: International Standard Randomized Controlled Trial Number (ISRCTN): 40367841; http://www.isrctn.com/ISRCTN40367841 (Archived by WebCite at http://www.webcitation.org/6pmfIJ9KK).

Keywords: pulmonary disease, chronic obstructive; randomized controlled trial; self-care; telehealth.

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Conflict of interest statement

Conflicts of Interest: None declared.

Figures

Figure 1
Figure 1
Participant flow legend. a: not mutually exclusive. b: defined as using the intervention for at least 30 days, during which time it was used for at least 3 out of 7 days per week. MRC: Medical Research Council; FEV1: forced expiratory volume in 1 s; FVC: forced vital capacity; COPD: chronic obstructive pulmonary disease, SGRQ-C: St George’s Respiratory Questionnaire for COPD.
Figure 2
Figure 2
Subgroup analyses for primary outcome.
See this image and copyright information in PMC

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