Skip to main content
. 2021 Jul 20;2021(7):CD013196. doi: 10.1002/14651858.CD013196.pub2

Pedone 2013.

Study characteristics
Methods Study design: single‐centre, open‐label, parallel block and stratified randomised controlled trial in Italy
Duration: 39 weeks
Setting: university pulmonary medicine outpatient clinic
Participants Population: 99 adults recruited from 1 university pulmonary medicine outpatient facility, in Rome, Italy
Baseline characteristics: % Male: 72 RM and 63 UC, Mean age: 74.1 RM and 75.4 UC, % White: not reported, % African: not reported, % LTOT: not reported, % Home oxygen: not reported, % Anxiety or depression: not reported, Baseline medications: not reported, FEV₁ (% mean): RM 52.5 and UC 55.4, FVC (% mean): RM 78.8 and UC 78.5, FEV₁/FVC (% mean): not reported, Current smokers (n): not reported, GOLD stage: II/III, COPD exacerbations last 12 months: not reported, Hospitalisations in past 12 months: not reported
Inclusion criteria: COPD GOLD II and III
Exclusion criteria: cognitive impairment preventing use of experimental intervention
Interventions Measurements were taken at baseline and daily
Treatment arms
  1. Telemonitoring via Bluetooth using Web‐based 'SweetAge' monitoring system

  2. Standard care

Outcomes Primary outcomes: number of exacerbations, number of hospitalisations
Secondary outcomes: not reported
Notes Funding: Lazio Region through FILAS
Other identifier: NCT01481506
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk A computer‐generated number list was used to randomise participants
Allocation concealment (selection bias) Unclear risk No further information
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 High risk No participants in usual care group dropped out, whereas 11/50 in RM group did (22%)
Selective reporting (reporting bias) Low risk Study authors reported outcomes as planned in trials registry, but SDs for length of stay were incomplete. Contacted study authors, who provided data for SDs. Trial was registered
Other bias Low risk None