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. 2021 Jul 20;2021(7):CD013196. doi: 10.1002/14651858.CD013196.pub2

Jakobsen 2015.

Study characteristics
Methods Study design: multi‐centre, open‐label, parallel individual randomised controlled trial in Denmark
Duration: 26 weeks
Setting: university hospitals
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
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
  1. Remote telemonitoring using a touch screen with a web cam for videoconferencing on discharge from hospital

  2. Usual care and treatment at hospital until discharge (typically between 5 and 7 days)

Outcomes Primary outcomes: re‐admission due to COPD
Secondary outcomes: mortality, NIV, hospitalisation days, QOL, adverse events, patient satisfaction, healthcare costs, physiological measures
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
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