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Implementing improved asthma self-management as routine

IMP2ART Cluster Randomised Trial (PG4/5)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN15448074
Enrollment
144
Registered
2019-12-05
Start date
2020-01-06
Completion date
Unknown
Last updated
2026-04-27

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 will be assigned by chance to receive either the IMP2ART approach or continue with their usual asthma care. A facilitator will visit IMP2ART practices over a year, offer the IMP2ART resource

Sponsors

University of Edinburgh
Lead Sponsor
NHS Lothian
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Computer systems: To facilitate data extraction, audit and feedback processes, and use of a review template, practices must use one of the four common EHR systems (Emis, SystmOne, Vision, or Microtest) – these systems cover 99% UK general practices. Practices will need to engage with OPC through a service level agreement (see section 3.3) to enable data extraction. Outlier coding conventions: The developmental work in PG1 revealed that a few practices use coding conventions that mean that the researchers will not be able to identify accurately the primary health outcome. Baseline data extraction will be undertaken before randomisation and these outlier practices excluded. Practice list size: The researchers require a minimum of 200 eligible patients/practice. The prevalence of ‘active asthma’ is 6%. Allowing for exclusion of children aged <5 years; people with co-morbid chronic obstructive pulmonary disease (COPD); a few patients excluded for clinical reasons; and natural turnover in the ‘active asthma’ list over 2 years, a practice with a list of 6,000 patients (estimated 360 patients on the asthma register) is likely to be the smallest practice with sufficient patients to be sure of having 200 eligible patients for analysis. Practice diversity: The researchers will monitor recruitment to ensure that participating practices represent a broad range of urban/rural location, high/low deprivation, small/large practices. Federations and the risk of contamination: A specific problem that may arise is ‘federations’ and ‘networks’ in which several practices work together. The decision about their inclusion/randomisation as one practice, or whether more than one of the partner practices within a federation can be involved and randomised as independent practices will depend upon how closely their day-to-day management is integrated (e.g. shared personnel, single management structure). The researchers will set up a sub-committee to discuss each case with the key criterion for inclusion being to avoid contamination of control practices. The committee will be chaired by Taylor (co-PI) with members Eldridge, Holmes and Neal representing methodological expertise as well as relevant background experience of models of primary care. Co-enrolment: The researchers will exclude practices already undertaking research or involved with an initiative that might affect the study outcomes. If there is any doubt, this will be adjudicated by the sub-committee who will consider each individual case.

Exclusion criteria

Exclusion criteria: Does not meet the inclusion criteria

Design outcomes

Primary

MeasureTime frame
Primary health outcome: the proportion of clinically eligible patients with at least one episode of unscheduled care for asthma in the second year after randomization, measured using routine coded data at 24 months Implementation outcome: the proportion of patients with an action plan, measured by questionnaire at 12 months post practice randomisation

Secondary

MeasureTime frame
1. Asthma symptom control, asthma attacks, ‘GINA’ control, asthma management and prescribing outcomes measured using routine coded data at baseline, 12 and 24 months. 2. Confidence in asthma, and health status & resource use measured using questionnaires at baseline, 12 and 24 months

Countries

England, Scotland, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: May 1, 2026