Jakobsen 2015.
Study characteristics | ||
Methods |
Study design: multi‐centre, open‐label, parallel individual randomised controlled trial in Denmark Duration: 26 weeks Setting: university hospitals |
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Participants |
Population: 57 adults recruited from 2 hospital in Copenhagen, Denmark: Frederiksberg University Hospital and Herlev University Hospital Baseline characteristics: % Male: 37.9 RM and 39.3 UC, Mean age: not reported, % White: not reported, % African: not reported, % LTOT: 3.4 RM and 7.1 UC, % Home oxygen: not reported, % Anxiety or depression: not reported, Baseline medications: Corticosteroids (prednisone), antibiotics (amoxicillin, clavulanic acid, beta2‐agonists and anticholinergics, fenoterol, ipratropium bromide nebuliser, 02 therapy as needed, sedative levomepromazine as needed, FEV₁ (% mean): RM 0.7 (0.4 to 2.1) and UC 0.7 (0.4 to 1.8), FVC (% mean): RM 1.5 (0.5 to 3.4) and UC 1.6 (0.7 to 3.4), FEV₁/FVC (% mean): not reported, Current smokers (n): RM 16 and UC 14, GOLD stage: III/IV, COPD exacerbations last 12 months: not reported, Hospitalisations in past 12 months: not reported Inclusion criteria: GOLD stage III or IV, able to follow instructions, admission > 2 days, ≥ 45 years of age Exclusion criteria: need for NIV/ventilator at time of baseline, severely overweight, serious comorbidity (cancer, unstable heart disease, diabetes, any condition that prevents participation), unable to follow instructions, temperature above 38 degrees requiring antibiotics, in another trial within 30 days of current trial, MMSE score < 24, not literate, unable to understand Danish, not able to complete follow‐up, severe psychiatric disorder, neuropsychological testing in last year, severe vision or hearing disorder |
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Interventions |
Run‐in: within 24 hours after hospitalisation, patient was trained with telehealth equipment; re‐test of equipment was done when patient got home within first 24 hours of admission; measurements taken at baseline, during intervention, and at 30, 60, 90, and 180 days after discharge Treatment arms
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Outcomes |
Primary outcomes: re‐admission due to COPD Secondary outcomes: mortality, NIV, hospitalisation days, QOL, adverse events, patient satisfaction, healthcare costs, physiological measures |
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Notes |
Funding: The Philanthropic Foundation TrygFonden, The Health Insurance Foundation, The Danish Lung Association, The Toyota Foundation, The Frederiksberg Foundation, and Lykfeldt’s grant Other identifier: NCT01155856 |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Patients were externally randomised 1:1 in fixed blocks of 4; the sequence was computer‐generated |
Allocation concealment (selection bias) | Low risk | Allocation was concealed in sequentially numbered sealed opaque envelopes delivered to hospitals in batches of 10. The envelope was opened by participant only after written consent |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Trial was reported as open‐label at clinical trials website |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Trial was reported as open‐label at clinical trials website |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Similar discontinuation numbers in each group; similar numbers of deaths in each group: IC 10/29 (24%), UC 8/28 (29%) |
Selective reporting (reporting bias) | Low risk | Outcomes were reported as planned in the protocol; study was registered at trial registry |
Other bias | Low risk | None |