Stamenova 2020.
| Study characteristics | ||
| Methods |
Study design: single‐centre, open‐label, parallel individual randomised controlled trial in Ontario, Canada Duration: 26 weeks Setting: community‐based hospital outpatient clinic |
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| Participants |
Population: 122 adults recruited from an outpatient COPD clinic (and from respirologist practices) who worked at the clinic and from an outpatient COPD rehab programme affiliated with the community‐based hospital Baseline characteristics: % Male: 56 RM and 52 SC, Mean age: 71.98 RM and 72.78 SC, % 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 0.50 and SC 0.45, FVC (% mean): not reported, FEV₁/FVC (% mean): RM 0.54 and SC 0.56, Current smokers (n): RM 10 and SC 9, GOLD stage: not reported, COPD exacerbations last 12 months: RM 2 and SC 1, Hospitalisations in past 12 months: RM 0 and SC 0 Inclusion criteria: diagnosis of COPD defined by respirologist as per clinical guidelines, > 18 years old Exclusion criteria: diagnosis of ILL, patients without Wi‐Fi access at home, non‐English‐speaking, taking part in other RM programmes, not able to use technology due to physical/cognitive impairment |
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| Interventions | Measurements taken at baseline (in person) and at 3 months and 6 months (in person or remotely) Treatment arms
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| Outcomes |
Primary outcomes: Partners in Health Scale (knowledge and skills to monitor disease) Secondary outcomes: SGRQ, Bristol COPD Knowledge Questionnaire, patient self‐report (COPD ED visits, hospital admissions, length of hospital stay, number of exacerbations, COPD‐related visits to GP, COPD‐related RN contacts, use of medication, smoking cessation) |
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| Notes |
Funding: Ontario Centres of Excellence Health Technologies Fund, grant 27009 Other identifier: NCT03741855 Other: 3‐arm study; each arm was separate; self‐monitoring (41), remote monitoring (41), standard care (40) |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | People were randomised 1:1:1 using a web‐based random number generator |
| Allocation concealment (selection bias) | High risk | Participants were allocated using sealed envelopes to conceal allocation from the clinical study specialist; however, the specialist opened the envelopes so participants and specialist were aware of the assignment |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Open‐label study |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Open‐label study |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Attrition was similar in each group at 3 and 6 months |
| Selective reporting (reporting bias) | Low risk | Outcomes were reported as planned, a protocol was published, and the trial was registered. SGRQ was reported in graph format; study authors were contacted for response |
| Other bias | Low risk | None |