Young 2012.
Methods |
Study design: 3‐month parallel RCT Setting: 11‐county region in north central Wisconsin, USA |
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Participants |
Population: 98 participants were randomised to home telemonitoring (49) or to control (49) Baseline characteristics Mean age (SD): monitoring 45.4 (16.8); control 43.7 (14) % male: monitoring 26.5; control 20.4 Inclusion criteria: participation in Community Health Access (a charity programme sponsored by the Marshfield Clinic and supported by the FHC) or FHC programmes (federally funded programmes to assist underserved, uninsured and underinsured individuals in the northern Wisconsin area), 19 years of age or older, English speaking, receipt of ≥ 1 asthma medication(s) dispensed in the 6‐month period ending January 31, 2009, diagnosis of asthma Exclusion criteria: enrolment in the FHC Pharmacy medication auto‐refill programme |
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Interventions |
Intervention: telephone consultation from pharmacists regarding asthma self management and medication use. Five pharmacists incorporated the intervention into their usual practice Control: usual care, which included mail receipt of a prescription refill with written medication use instructions |
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Outcomes | Asthma Control Test, Patient Activation Measure, Morisky Medication Adherence Scale. Measured at 3‐month endpoint and at 6‐month follow‐up | |
Notes | Funding: Grant 1UL1RR025011 from the Clinical & Translational Science Award programme of the National Center for Research Resources, National Institutes of Health | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Randomised by the data manager. No details of how the sequence was generated |
Allocation concealment (selection bias) | Low risk | Research assistants then forwarded participant contact information to a data manager for random assignment to the intervention or control group. Data manager forwarded intervention group participants’ contact information to the FHC Pharmacy Manager for allocation to pharmacists |
Blinding of participants and personnel (performance bias) Objective outcomes | Low risk | It would not have been possible to hide allocation from participants and personnel, but it is unlikely that this would have introduced bias for objective outcomes (e.g. number of people having exacerbations) |
Blinding of participants and personnel (performance bias) Subjective outcomes | High risk | Subjective outcomes such as quality of life and symptom scales filled in by participants or personnel may have been subject to performance bias |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Research assistants and researchers were blinded to allocation of participants to intervention and control groups |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Dropout was balanced between groups (˜ 15% in both groups) |
Selective reporting (reporting bias) | Low risk | No trial registration, but no evidence of selective reporting in the paper |
Other bias | Low risk | None noted |
ACT = Asthma Control Test
ACQ = Asthma Control Questionnaire
AQLQ = Asthma Quality of Life Questionnaire
CSQ = Client Satisfaction Questionnaire
ED = emergency department
KASE‐AQ = Knowledge, Attitude and Self‐efficacy Asthma Questionnaire
NR = not reported
PAQLQ = Paediatric Asthma Quality of Life Questionnaire
PEF = peak expiratory flow
RCT = randomised controlled trial