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. 2021 Apr 19;2021(4):CD013246. doi: 10.1002/14651858.CD013246.pub2

Nguyen 2008.

Study characteristics
Methods Study design: multi centre, single‐blinded, parallel randomised controlled trial in the USA.
Duration: 26 weeks (but study ended early)
Setting: secondary care
Participants Population: 50 adults recruited from two academic medical centres at the University of San Fransisco and University of Washington
Baseline characteristics: mean age 70 years, male: 56%, current smokers (n): 3/39, FEV1 (% predicted): 53, concomitant medications: oxygen therapy (11/39), moderate to severe COPD, ethnicity: Caucasian, exacerbations in the last 12 months: NR, cognitive function: NR (but 59% had intermediate computer or Internet skills)
Inclusion criteria: COPD diagnosis, clinically stable, FEV1/FVC < 70% and FEV1 < 80% predicted after bronchodilator, activities of daily living limited by dyspnoea, English speaking, able to use computer, oxygen saturation > 85% on < 6L/min nasal oxygen during six‐minute walk test (6MWD), able to rate shortness of breath during exercise, moderate to severe COPD,
Exclusion criteria: Other active illness, formal pulmonary rehabilitation training in last six months
Interventions Measurements taken at baseline, 3 months and 6 months
Treatment arms:
  • Internet‐based dyspnoea self‐management programme

  • Usual care (face‐to‐face personalised dyspnoea and exercise plan, and self‐monitoring)

Outcomes
  • Quality of life (SF‐36 sub scales, CRQ sub scales)

  • Physical activity (6MWD, endurance, strengthening, stage of readiness for exercise)

  • Patient satisfaction

  • Impact on health behaviours (dyspnoea knowledge scale)

  • Exacerbations

Notes Funding: Robert Wood Health e‐Technologies Initiative grant, General Clinical Research at University of Washington, UC San Fransisco, National Centre for Research Resources
Other identifiers: NCT00102401
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomisation was achieved by generating a random sequence using a computer program
Allocation concealment (selection bias) Low risk Allocation was concealed in sealed opaque envelopes
Blinding of participants and personnel (performance bias)
All outcomes High risk The study nurse opened the randomisation envelope in the first half of the visit as a requirement due to registering the participant to access web questionnaires. The participants were not informed of their assignment until the visit was complete
Blinding of outcome assessment (detection bias)
All outcomes High risk Subjective outcomes such as QOL, self‐efficacy and participant satisfaction likely to be high risk as they are self‐reported outcomes
Incomplete outcome data (attrition bias)
All outcomes High risk Higher attrition percentage in the eDSMP group compared with fDSMP group due to unable or unwilling to access the website or use PDA, scheduling conflict, recurrent angina, or moved away from the area. Outcomes are reported at multiple time points, and high attrition rates may affect outcome data
Selective reporting (reporting bias) Low risk All outcomes reported as planned in the protocol on clinicaltrials.gov website. Study was stopped early but not reported when it was terminated
Other bias Low risk None identified