Tivota 2015.
Methods |
Study design: single‐centre, open‐label, parallel individual randomised controlled trial in Norway Duration: 104 weeks Setting: hospital ‐ Trondheim University Hospital |
Participants |
Population: 172 adults recruited from Department of Thoracic Medicine or Observation Unit at Trondheim University Hospital in Norway Baseline characteristics: % Male: 43 IC and 45 UC, Mean age: 72.5 IC and 73.1 UC, % White: not reported, % African: not reported, % LTOT: not reported, % Home oxygen: not reported, % Anxiety or depression: not reported, Baseline medication: Inhaled LAMA: IC group: 39%; UC group 51%. LABA + ICS: IC group: 70%; UC group: 71%, FEV₁ (% mean): IC 34.9 and UC 33.4, FVC (% mean): not reported, FEV₁/FVC (% mean): not reported, Current smokers (n): IC 18 and UC 15, GOLD stage: III/IV, COPD exacerbations last 12 months: not reported, Hospitalisations in past 12 months: IC: 1.0 (1,1) and UC: 1.0 (1,2) Inclusion criteria: admission due to AECOPD, GOLD III/IV diagnosis, residing in Trondheim area, Norwegian‐speaking, able to sign consent form Exclusion criteria: short life span due to serious disease (< 6 months' survival) |
Interventions | Routine calls per month; home visits at days 3 and 14, then at 6, 12, 24 months post discharge Treatment arms
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Outcomes |
Primary outcomes: number of hospital admissions (AECOPD), number of in‐hospital days (AECOPD), QOL (SGRQ), HADS Secondary outcomes: mortality, Charlson Co‐morbidity Index |
Notes |
Funding: Central Norway Regional Health Authority and The Research Council of Norway Other identifier: NCT00702078 |