To 2020.
Study characteristics | ||
Methods |
Design: single‐blind RCT Duration: 4‐week programme; data collected at 6 weeks Location: Hong Kong Setting: outpatient clinic of a government‐funded regional hospital |
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Participants |
Population: 30 outpatients with COPD randomly assigned to 15 IMB model group and 15 usual care Baseline characteristics COPD severity: moderate to very severe Age: IMB 75.6 (SD 5.0) years; usual care 75.9 (SD 4.7) years % males: IMB 14% (93.3%); usual care 15% (100.0%) FEV1 % predicted: IMB 43.7 (SD 10.6); usual care 43.4 (SD 13.3) Inclusion criteria: confirmed diagnosis of COPD by spirometry, with bronchodilator FEV1/FVC < 0.7 (70% predicted) and presence of airflow limitation, aged ≥ 18 years, currently prescribed regular self‐administered inhaled medication and able to communicate in Cantonese Exclusion criteria: clinical record of cognitive impairment, psychiatric problems, too frail to participate and already attending a disease management programme for COPD |
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Interventions |
Treatment arms
Allowed co‐medications: LABA, LAAC, ICS, combined LABA and ICS (1 inhaler) |
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Outcomes |
Primary outcomes: adherence to inhalation therapy and inhalation techniques Secondary outcomes: symptom severity and quality of life |
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Notes |
Funding: not reported Identifiers: 10.1111/ijn.12799 |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated random sequence of codes was used for randomisation process, prepared by (quote) "an independent statistician to determine group allocation for each participant." |
Allocation concealment (selection bias) | Low risk | Allocation of sequence was concealed in opaque sealed envelopes. |
Blinding of participants and personnel (performance bias) all outcomes | High risk | This was a single‐blind RCT, it was not possible to blind participants or personnel due to the nature of the intervention. |
Blinding of outcome assessment (detection bias) all outcomes | Low risk | Quote: "Another research nurse who did not have any information about the assignment collected the outcome data." |
Incomplete outcome data (attrition bias) all outcomes | Unclear risk | 30 participants completed the study, although the attrition rate was 14.3%. This percentage referred to those participants who completed consent forms and agreed to participate, but then withdrew before baseline data collection. It was unclear why these participants were not included in the ITT analysis if they had been randomised in the study. |
Selective reporting (reporting bias) | Unclear risk | Trial protocol was not found, unclear if outcomes were reported as planned. |
Other bias | Low risk | None identified. |