Tabak 2014.
Study characteristics | ||
Methods |
Study design: single‐blinded, parallel randomised controlled trial in the Netherlands. Duration: 13 weeks Setting: primary and secondary care |
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Participants |
Population: 29 adults recruited from one hospital and primary care physiotherapy practices in Enschede, Netherlands. Five participants withdrew before baseline measurements were taken Baseline characteristics: mean age 63 years, male: 50%, current smokers (n): 8/23, FEV1 (% predicted): 53, dyspnoea (MRC score): 3.5, concomitant medications: not reported Inclusion criteria: clinical diagnosis of COPD according to GOLD guidelines, no exacerbation in the month prior to enrolment, ≥ 3 exacerbations or hospitalisations (respiratory related) in the previous two years, ex/current smoker, age > 40 years, FEV1: 25‐80% predicted, Dutch speaking and understanding, Internet at home Exclusion criteria: other serious illness, short life expectancy, other conditions affecting bronchial symptoms/lung function, severe mental illness, uncontrolled diabetes during COPD exacerbation in past, hospitalisation due to diabetes in previous two years, regular oxygen therapy, maintenance antibiotic therapy, alpha‐1‐antitrypsine deficiency, disorders/conditions seriously affecting daily activities, hand impairment/unable to use app. |
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Interventions | Measurements taken at baseline, 1 month, 3 months, 6 months and 9 months Treatment arms:
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Outcomes |
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Notes |
Funding: NL Agency (a division of the Dutch Ministry of Economic Affairs) Other identifiers: Netherlands trial register (NTR3072) |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Participants were randomised using a computer‐generated randomisation list (block stratified) |
Allocation concealment (selection bias) | Low risk | Allocation was concealed in sealed envelopes by a data manager |
Blinding of participants and personnel (performance bias) All outcomes | High risk | No further information provided, but blinding would not be possible due to the nature of the treatment |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Self‐reported outcomes are likely to be high risk of bias as the participant is the one reporting the outcome (QOL, impact on health behaviour, and self‐efficacy). For objective outcomes, it is not clear whether assessors were blinded or not |
Incomplete outcome data (attrition bias) All outcomes | High risk | 86% withdrew in the usual care group, and 33% in the telehealth group |
Selective reporting (reporting bias) | Unclear risk | Contacted authors regarding a few of the outcomes as they were not reported in a format that could be used. Also, 9‐month data were not reported in the publication |
Other bias | Unclear risk | Significant difference of dyspnoea at baseline. Waiting to hear from authors |