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

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
  1. Home integrated disease management administered by specialist nurse including call centre for support, interactive e‐learning, and individualised plan for self‐management of disease

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