Prabhakaran 2009.
Methods |
Study design: 3‐month parallel RCT Setting: 1 hospital in Singapore Participants were recruited between 1 August 2007 and 30 June 2008 |
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Participants |
Population: 120 participants were randomised to home telemonitoring (60) or to control (60) Baseline characteristics Mean age (SD): monitoring 37 (12); control 40 (13) % male: monitoring 35; control 47 Inclusion criteria: 21 years of age or older, admitted for an acute exacerbation of asthma, own a mobile phone, know how to use an SMS system, English speaking, willing to participate in the study and give written consent Exclusion criteria: significant co‐morbidity e.g. bronchiectasis, heart failure, diabetes mellitus with complications, stroke, renal impairment, COPD; did not know how to use an SMS system, had mild intermittent asthma |
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Interventions |
Intervention: The 60 participants in the intervention group had SMS monitoring to assist with management of their asthma control for the next 3 months Control: The 60 participants in the control group were left to self manage their asthma for 3 months All 120 participants recruited were seen by a trained asthma nurse educator, who assessed their asthma control, compliance with treatment and inhaler technique before providing individualised asthma education |
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Outcomes | Asthma Control Test, use of nebulisation, ED visits and hospital admissions for asthma since the last admission 12 weeks previously | |
Notes | Funding: NR | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Allocation was done from an envelope with slips of paper. Participants had to draw from the envelope to discover their allocated group |
Allocation concealment (selection bias) | Unclear risk | Unclear whether it was possible to predict allocation from the slips used |
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 | High risk | It would have been possible to blind outcome assessors, but no information suggests this was done |
Incomplete outcome data (attrition bias) All outcomes | Low risk | "Since all patients received the inpatient phase of asthma education, the intention‐to‐treat approach was used to analyse the secondary objective on clinical outcomes. We were not able to contact three subjects from the control group and two subjects from the intervention group to assess their asthma control and number of nebulizations. Nevertheless, information about the number of emergency visits and hospital admissions for asthma were retrieved for all patients from the hospital computer system" |
Selective reporting (reporting bias) | Low risk | No study protocol found but named outcomes well reported |
Other bias | Low risk | None noted |