Tabak 2014.
| Study characteristics | ||
| Methods |
Study design: single‐centre, single‐blind, parallel individual randomised controlled trial in the Netherlands Duration: 39 weeks Setting: hospital and primary care physiotherapy practice |
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| Participants |
Population: 29 adults recruited from a hospital and from primary care physiotherapy practices in Enschede, Netherlands Baseline characteristics: % Male: 50 IC and 50 UC, Mean age: 64.1 IC and 62.8 UC, % White: not reported, % African: not reported, % LTOT: not reported, % Home oxygen: not reported, % Anxiety or depression: not reported, Baseline medications: not reported, FEV₁ (% mean): IC 50.0 and UC 36.0, FVC (% mean): not reported, FEV₁/FVC (% mean): not reported, Current smokers (n): IC 4 and UC 4, GOLD stage: not reported, COPD exacerbations last 12 months: not reported, Hospitalisations in last 12 months: not reported Inclusion criteria: clinical diagnosis of COPD according to GOLD guidelines, not exacerbation‐free in the month prior to enrolment, ≥ 3 exacerbations or hospitalisations (respiratory related) in the previous 2 years, ex/current smoker, 40+ years, FEV₁ 25% to 80% predicted, Dutch‐speaking and understanding Dutch, Internet at home Exclusion criteria: other serious illness, short life expectancy, other condition affecting bronchial symptoms/lung function, severe mental illness, uncontrolled diabetes during COPD exacerbation in past, hospitalisation due to diabetes in previous 2 years, regular oxygen therapy, maintenance antibiotic therapy, alpha‐1‐antitrypsin deficiency, disorder/condition seriously affecting daily activities, hand impairment/unable to use app |
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| Interventions |
Run‐in: two 90‐minute sessions with the nurse practitioner for disease self‐management; measurements taken at baseline and at 1, 3, 6, and 9 months Treatment arms
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| Outcomes |
Primary outcomes: number of hospitalisations, length of stay, number of emergency department visits Secondary outcomes: 6MWT, EuroQoL‐5D, Multidimensional Fatigue Inventory 20, Clinical COPD Questionnaire, dyspnoea |
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| Notes |
Funding: NL Agency, a division of the Dutch Ministry of Economic Affairs Other identifier: 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 (Blocked Stratified Randomisation version 5; Steven Piantadosi) |
| Allocation concealment (selection bias) | Low risk | Participants were allocated by a data manager in order of inclusion following the randomisations list, which was placed in a sealed envelope |
| 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 | High risk | 85% in the usual care group withdrew, and 33% in the telehealth group "The study showed a high attrition rate. The strict criteria in relation to exacerbations/hospitalisations meant that the participants in general had a poor and unstable health status, especially in the control group, who had significantly worse dyspnoea levels" |
| Selective reporting (reporting bias) | Low risk | Contacted study authors regarding a few of the outcomes, as they were not reported in a format that could be used. The trial was registered, and all outcomes were reported as planned |
| Other bias | Low risk | None |