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

Ringbaek 2015.

Study characteristics
Methods Study design: multi‐centre, open‐label, parallel block randomised controlled trial in Denmark
Duration: 26 weeks
Setting: respirator outpatient clinics
Participants Population: 281 adults recruited from pulmonary wards at 4 hospitals: Hvidovre, Bispedjerg, Herlev, Amager Hospitals
Baseline characteristics: % Male: 39 TM and 55 UC, Mean age: 69.8 TM and 69.4 UC, % White: not reported, % African: not reported, % LTOT: 26 TM and 27 UC, % Home oxygen: not reported, % Anxiety or depression: not reported, Baseline medications: Oral prednisone (8.5%), Roflumilast (4.6%), ICS (91%), LAMA (89%), LABA (96%), FEV₁ (% mean): TM 34.9 and UC 33.8, FVC (% mean): not reported, FEV₁/FVC (% mean): not reported, Current smokers (n): TM 35 and UC 47, GOLD stage: severe and very severe, COPD exacerbations last 12 months: not reported, Hospitalisations in past 12 months: TM 0.91 (0 to 7) and UC 1.22 (0 to 23)
Inclusion criteria: stable severe to very severe COPD as measured by GOLD, at high risk of exacerbations and hospitalisations, FEV₁ < 0.7, post‐bronchodilator FEV₁ < 60% predicted, hospitalisation in last 3 years due to exacerbation, LTOT for at least 3 months, regular respiratory outpatient clinic visits, COPD as main cause of disability, living in 1 of 6 municipalities of Copenhagen, living within area of recruiting hospital
Exclusion criteria: COPD exacerbation 3 weeks before trial, not giving informed consent, unable to use tablet computer, not able to participate/living outside catchment area 2 weeks or more during study period, language barrier or cognitive disorder, no telephone line
Interventions Measurements taken at baseline and at 6‐month follow‐up
Treatment arms
  1. Tablet computer used to send measurements to a call centre

  2. Outpatient pulmonary rehab and supported discharge to reduce pulmonary re‐admissions

  3. Usual care

Outcomes Primary outcomes: health‐related QOL by 15D questionnaire
Secondary outcomes: CAT
Notes Funding: not reported
Other identifier: not reported
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk "1:1 allocation using randomised blocks of four (via numbered envelopes) for 6 months"
Allocation concealment (selection bias) Low risk "1:1 allocation using randomised blocks of four (via numbered envelopes) for 6 months"
Blinding of participants and personnel (performance bias)
All outcomes High risk It would not be possible to blind patients in the telehealth care arm to treatment, nor people who are administering the intervention due to the nature of the intervention
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Unclear whether outcome assessors were blinded
Incomplete outcome data (attrition bias)
All outcomes Low risk Similar numbers of deaths were observed in both treatment arms (8 vs 9). Two people in the intervention arm withdrew for technical reasons (although the technical reasons are not explained further). Similar attrition overall in both treatment groups
Selective reporting (reporting bias) Unclear risk No protocol was registered; it is not clear whether outcomes were reported as planned
Other bias Low risk There was good compliance with the TM intervention: "100 (82.6%) patients participated in at least six consultations"