Moudgil 2000.
| Methods | Open, prospective, randomised, controlled, parallel group study examining individually‐based asthma education and structured follow‐up for people with asthma. | |
| Participants | Potential participants were identified through registration and diagnostic records inner city general practices in the Birmingham area. All eligible patients were requested to attend their general practice for review by the researcher. Participants were randomised to either the intervention or control group prior to initial appointments being sent. Inclusion criteria: All white European (WE) or Indian sub‐continent (ISC) participants with asthma, from 12 participating general practices in the Birmingham area, aged 11 to 59 years Exclusion criteria: Minority groups (e.g. Afro‐Caribbean and some mixed race) and a small number of Bangladeshi and/or only Bengali speaking patients who did not speak English, Punjabi, Urdu or Hindu Number identified: n = 1217 Number randomised: n = 689 (Intervention group: n = 343 and Control group: n = 346) |
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| Interventions |
Study dates: August 1995 to 1996 Sample size: n = 331 in each arm Intervention group participants: received individual asthma education session of 40 minutes duration with an asthma educator fluent in each participants own dialect (e.g. English, Punjabi, Hindi or Urdu). Emphasis during the session was on:
Participants were given peak flow meters free of charge and a booklet to record measurements during the 12‐month intervention period, along with an individually‐tailored asthma management plan and educational literature (in the appropriate dialect) describing aspects of asthma and asthma management. Plans were based on existing BTS guidelines. Educational literature in the relevant ethnic dialect, describing aspects of asthma and its management, including triggers, medication, delivery devices etc were distributed to all participants in the intervention group (literature provided by Allen & Hanburys). Educational intervention was reinforced at 4 and 8 months, although it is not stated how this was done. Control group participants: attended their GP at the start and end of the study for outcome assessment and were asked to continue their usual asthma follow‐up and care for asthma (e.g. generic asthma programme). |
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| Outcomes |
Outcome measures 1. Number of asthma‐related hospital admissions 2. Number of asthma‐related presentations to the ED 3. Number of asthma‐related home visits from GP 4. Number of asthma‐related visits (during regular hours) to GP 5. Prescriptions of oral steroids 6. Prescriptions of antibiotic 7. Asthma QoL (Juniper ‐ 32 questions about asthma events in the last 2 weeks and scores responses on 7‐point scale (1 = severe limitation or most of the time; 7 = no limitation or none of the time)) Outcomes were performed 12 months post intervention |
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| Notes | Although the study included participants from the age of 11, data presented combines adult data, thus outcomes are not shown separately for the paediatric population. Study measured clinical outcomes for 294 (of 344) participants, and Asthma QoL outcomes for 280 (of 344) participants. Domains for activity limitation, symptoms, emotional function and exposure to environmental stimuli. Some terms did not translate directly into the different dialects used and the terms used were agreed by two bilingual persons after a translation‐back translation process. Funding: West Midlands Regional Health Authority and North Birmingham Health Authority |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Randomisation was computer‐generated and randomly allocated |
| Allocation concealment (selection bias) | Unclear risk | Participants were reviewed at local GP clinics by researcher. Study authors did not describe how allocation was concealed |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Unclear if outcome assessor was blinded to intervention groups |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Study authors did not describe if outcomes assessor was blinded to intervention groups |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Clinical data was available for (86%) and 76% for Asthma QoL |
| Selective reporting (reporting bias) | Low risk | Intention‐to‐treat analysis not used. Per protocol analysis |
| Other bias | Unclear risk | Objective measurement of airflow obstruction (e.g. peak flow) recorded for 12 months ‐ nil data reported in paper |