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A cluster randomised controlled trial to assess the effectiveness and costs of implementing asthma risk registers to identify and improve management of high risk asthma patients in primary care

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN36918958
Enrollment
524
Registered
2007-05-30
Start date
2007-03-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma Respiratory Asthma

Interventions

Practices randomised to the intervention arm will add at-risk asthma patients to an at-risk register. Identified patients will be added to an asthma risk register involving: 1. Electronic tagging of

Sponsors

Asthma UK (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: PRACTICES: 1. Participation is open to all practices with adequate computer systems which are used to support routine consultations 2. Practices covering urban and rural populations, deprived and affluent areas and various practice sizes and set-ups PATIENTS: High risk patients aged 5+ years at participating practices will, according to British asthma guideline recommendations, be identified on the basis of having: 1. Severe asthma, recognised by one or more of: 1.1. Previous near-fatal asthma 1.2. Hospital admission for asthma in the last five years 1.3. Two or more attendances at Accident and Emergency (A&E) or out-of-hours services for asthma in the last year 1.4. Requiring step four or five treatment 1.5. Brittle asthma PLUS: 2. A record in the notes (of patients or their primary carers for children) of adverse behavioural or psychosocial characteristics including one or more of: 2.1. Poor adherence to recommended management 2.2. Failure to attend primary care or hospital appointments 2.3. Self-discharge from hospital 2.4. Psychosis, depression, other psychiatric illness or deliberate self-harm 2.5. Current or recent major tranquiliser use 2.6. Alcohol or drug abuse 2.7. Denial 2.8. Obesity 2.9. Learning difficulties 2.10. Employment problems 2.11. Income problems 2.12. Social isolation 2.13. Childhood abuse 2.14. Severe domestic, marital or legal stress

Exclusion criteria

Exclusion criteria: PRACTICES: Those with pre-existing at-risk asthma registers or similar strategies to study intervention. PATIENTS: Patients who meet the inclusion criteria but are felt not appropriate to be included on an at-risk register for some other factor will be individually negotiated.

Design outcomes

Primary

MeasureTime frame
Moderate-severe asthma exacerbations, measured at one year.

Secondary

MeasureTime frame
1. Exacerbations from: 1.1. Death or hospitalisation 1.2. Emergency attendance (at the hospital, the practice or via a home visit) 1.3. Out-of-hours medical contact 1.4. A course of oral prednisolone or a boost in oral steroids for those receiving them regularly 2. Asthma-related routine primary and secondary care attendances and medication use 3. Healthcare costs All secondary outcomes measured at one year.

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026