Walker 2018.
Study characteristics | ||
Methods |
Study design: multi‐centre, open‐label, parallel individual randomised controlled trial in Spain, United Kingdom, Slovenia, Estonia, and Sweden Duration: 39 weeks Setting: clinics, hospitals, and community health services |
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Participants |
Population: 312 adults recruited from 6 sites in 5 countries (United Kingdom 75, Sweden 63, Estonia 80, Spain 61, Slovenia 33) Baseline characteristics: % Male: 66 RM and 65 UC, Mean age: 71 RM and 71 UC, % White: not reported, % African: not reported, % LTOT: not reported, % Home oxygen: not reported, % Anxiety or depression: Mean depression PHQ‐9 score RM 6.27 (5.69) and UC 5.97 (5.79), Baseline medications: not reported, FEV₁ (% mean): RM 49.4 and UC 50.4, FVC (% mean): RM 73.8 and UC 75.8, FEV₁/FVC (% mean): RM 0.53 and UC 0.53, Current smokers (n): not reported, GOLD stage: RM: I (3%), II (47%), III (36%), IV (15%) and UC: I (2%), II (48%), III (39%), IV (11%), COPD exacerbations last 12 months: 1 exacerbation: RM 63 (41%) and UC 59 (37%); More than 1 exacerbation: RM 91 (59%) and UC 99 (63%), Hospitalisations in past 12 months: RM 64 (42%) and UC 65 (41%) Inclusion criteria: GOLD grade II or higher, exacerbations or hospitalisation or both in the last year, comorbidities such as CHF, SDB, smoking pack‐years > 10 years, able to provide written consent, able to use TM equipment at home, reliable mobile phone coverage at home, > 60 years Exclusion criteria: any condition likely to put patient at risk, significant visual or mental condition, planned long‐time absence from home |
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Interventions | Measurements taken at baseline, every 2 months (CAT, PHQ‐9, MLHFQ), every 3 months (EQ‐5D, exacerbations, medication use, use of GP), and at end of study Treatment arms
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Outcomes |
Primary outcomes: time to first hospitalisation, quality of life (change in EQ‐5D utility index score) Secondary outcomes: moderate exacerbation rate, hospitalisation, CAT, PHQ‐9, MLHFQ questionnaires, cost utility analysis |
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Notes |
Funding: European commission grant Other identifier: NCT01960907 |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Concealed computer‐generated randomisation with 4‐element block design stratified by centre was used |
Allocation concealment (selection bias) | Unclear risk | Randomisation sequence was concealed, but it is unclear how allocation was concealed |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Trial was open‐label |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Trial was open‐label |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Attrition was similar in TM (29%) and control groups (22%) |
Selective reporting (reporting bias) | Low risk | Outcomes were reported as planned. Study authors were contacted about time to first hospitalisation to see if they could provide HR and 95% CI, which they provided on request. Trial was registered at clnicaltrials.gov |
Other bias | Low risk | None |