Vianello 2016.
| Study characteristics | ||
| Methods |
Study design: multi‐centre, open‐label, parallel individual randomised control trial in Italy Duration: 52 weeks Setting: primary and secondary clinics |
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| Participants |
Population: 334 adults recruited from a hospital or from outpatient pulmonary clinics in Padova, Treviso, Venice, and Verona, Italy Baseline characteristics: % Male: 71 RM and 73 UC, Mean age: 75.96 RM and 76.48 UC, % White: not reported, % African: not reported, % LTOT: 41.30 RM and 39.42 UC, % Home oxygen: not reported, % Anxiety or depression: HADSA: RM 4.68 (3.45) and UC 5.4 (3.35), HADSD: RM 5.1 (4.42) and UC 5.48 (4.49), Baseline medications: LABA: RM 97% and UC 94%, LAMA: RM 87.17% and UC 86.27%, Inhaled ICS: RM 83.48% and UC 76.92%, Systemic steroid: RM 6.52% and UC 4.81%, FEV₁ (% mean): RM 41.90 and UC 41.87, FVC (% mean): not reported, FEV₁/FVC (% mean): not reported, Current smokers (n): RM 10 and UC 3, GOLD stage: III/IV, COPD exacerbations last 12 months: not reported, Hospitalisations in past 12 months: not reported Inclusion criteria: 18+ years, COPD GOLD class III and IV, life expectancy > 12 months, able to use telemonitoring equipment (assisted or alone) Exclusion criteria: unwilling to use telemonitoring equipment, significant lung disease, not willing to provide consent, serious social problems, negative feedback from GP |
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| Interventions | Measurements at baseline and at 12 months Treatment arms
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| Outcomes |
Primary outcomes: HRQL, SF‐36v2 (Italian version) Secondary outcomes: HADS, number and duration of hospitalisations, AECOPD, number and duration of any cause hospitalisations, number of re‐admissions due to exacerbations, number of any cause re‐admissions, number of appointments with pulmonary specialist, number of ED visits, number of deaths |
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| Notes |
Funding: part of the Renewing Health Project founded by the European Commission Other identifier: NCT01513980 |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | A computer programme was used for randomisation of participants and allowed check of any inequality of characteristics by age and gender. Patients were randomised in a 2:1 allocation |
| Allocation concealment (selection bias) | High risk | Allocation was not concealed, but participants were allocated in a 2:1 ratio for TM and control groups, respectively |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Trial was open‐label |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Trial was open‐label |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Attrition was similar in each treatment group, although it was > 20% in each group and overall |
| Selective reporting (reporting bias) | Low risk | Outcomes were reported as planned; study was registered at clinicaltrials.gov |
| Other bias | Low risk | None |