Bender 2010.
| Methods |
Design: single‐blind, parallel‐group randomised controlled trial Duration: 10 weeks Setting: single site; participants recruited through newspaper adverts; in association with community allergy practices. USA Trial registration: not reported |
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| Participants |
Population: 50 adults with asthma randomised to an interactive voice response (IVR) intervention (n = 25) or usual care (UC) (n = 25) Age: 18 to 65 years; mean age (SD) in IVR group 39.6 (12.8) years and in UC group 43.5 (14.3) years Baseline asthma severity: physician‐diagnosed asthma for which they were prescribed daily inhaled corticosteroid treatment; no other severity information given Inclusion criteria: adults 18 to 65 years old who had physician‐diagnosed asthma for which they were prescribed daily inhaled corticosteroid treatment. Participants were recruited through newspaper advertising and in co‐operation with community allergy practices and received $25 for each completed study visit Exclusion criteria: significant disease or disorder that, in the opinion of the investigator, might influence results of the study or the patient’s ability to participate in the study (this included other chronic health disorders, current substance abuse or dependence, mental retardation or psychiatric disorder); current participation in another asthma‐related research or clinical trial Percentage withdrawn: no withdrawal Other allowed medication: not specifically reported |
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| Interventions |
Intervention summary: 2 automated IVR telephone calls separated by 1 month, with 1 additional call if recently reported symptoms of poorly controlled disease or failure to fill a prescription. Calls were completed in less than 5 minutes and included content designed to inquire about asthma symptoms, deliver core educational messages, encourage refilling of inhaled corticosteroid prescriptions and increase communication with providers Control summary: usual care Complex intervention: no |
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| Outcomes |
Outcomes measured: AQLQ, ACT, BMQ, adherence with use of an electronic monitor Adherence calculation: electronic adherence device or canister weight to give a mean % adherence (exact details of calculation not provided) |
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| Notes |
Type of publication: single peer‐reviewed full‐text journal article Funding: supported by the Investigator‐Sponsored Study Program of AstraZeneca |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | A randomization table generated before study initiation determined group assignment by order of entry into the study |
| Allocation concealment (selection bias) | Unclear risk | No details |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | No blinding of participants described. Main outcome ‐ adherence ‐ objectively measured, but other outcomes such as ACQ and AQLQ subject to performance bias |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Investigators remained blind to treatment until final data set was completed. However, for participant‐reported outcomes such a AQLQ and ACQ, the participant is the outcome assessor; therefore these outcomes are at high risk of detection bias |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Although attrition not specifically reported, end of study data given for all 50 randomised participants |
| Selective reporting (reporting bias) | Unclear risk | No prospective trial registration identified, but all outcomes stated in methods clearly reported |
| Other bias | Low risk | None noted |