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

Abstract

BackgroundWe 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).ObjectiveThe 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.MethodsWe 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).ResultsA 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.ConclusionsThe 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 registrationInternational Standard Randomized Controlled Trial Number (ISRCTN): 40367841; http://www.isrctn.com/ISRCTN40367841 (Archived by WebCite at http://www.webcitation.org/6pmfIJ9KK)

Are COPD self-management mobile applications effective? A systematic review and meta-analysis

“…All 13 trials [13][14][15][16][17][18][19][20][21][22][23][24] were published after 2008, with most (12 of 13) published since 2011. Trials were conducted in a number of countries and settings; however, most were in the Netherlands [17][18][19][20] or the United Kingdom 13,16,22,23 . Five trials 14,17,18,23,25 included fewer than 50 participants and the largest number of participants was 343 21 .…”

“…Baseline measures of lung function were identified in nine trials [13][14][15][16][17][18]20,21,25 . Study duration varied from 2 weeks 23 to 12 months 15,16,20,22 .…”

“…Eight of the interventions 13,15,17,19,21,[23][24][25] were smartphone-based, using custom applications whereby participants entered COPD symptom data and received custom or automated feedback based on their responses. Healthcare professional involvement through active monitoring of entered data, clinical advice, or intervention on deteriorating observations was noted in seven trials 14,16,[18][19][20]22,24 . Eleven trials [13][14][15][17][18][19][20][21][23][24][25] delivered the intervention through a smartphone and two 16,22 utilized a mobile tablet device.…”

“I just know”: exploring self-knowledge in chronic obstructive pulmonary disease

“…Participants were recruited as part of a clinical trial (including pilot trial) (Farmer et al, 2017) evaluating the effectiveness of a digital health intervention supporting self-management in COPD. A qualitative, interview based study was conducted to explore participants' understanding and experience of living with and managing their condition at home, and how such an intervention might influence their self-management.…”

Evaluating the impact of the Eastern Academic Health Science Network Transformation Support Unit

“…Velardo et al (2017) found a digital self-management health intervention led to higher compliance rates with the treatments and encouraged clinicians to be more engaged with monitoring patient outcomes. Farmer et al (2017) found that a similar intervention had no significant impact on condition-specific outcomes, but they did observe significant improvements in general health and significant reductions in the number of visits to practice nurses and general practitioners.…”