Study identification

PURI

https://redirect.ema.europa.eu/resource/1000000556

EU PAS number

EUPAS1000000556

Study ID

1000000556

Official title and acronym

Assessing the cost-effectiveness of Smartinhaler technology in primary care: a health economic decision Model in school-Aged children (SMART-MOD)

DARWIN EU® study

No

Study countries

United Kingdom

Study description

This study aims to evaluate whether digital interventions, such as Smartinhalers, are cost-effective tools for improving medication adherence and reducing unscheduled medical contacts (UMCs) among school-aged children with asthma.
Poor adherence to maintenance therapy is a known contributor to exacerbations and emergency care use in paediatric asthma, causing a significant financial burden to the NHS.

This study will be conducted in three key phases:

Phase 1 involves a secondary analysis of a retrospective cohort of school-aged children with asthma using NHS primary care data. This phase will examine patterns of ICS adherence (e.g. via Medication Possession Ratio), the frequency and nature of UMCs, and estimate mathematical relationships such as risk ratios and average treatment effects. Seasonal variation in adherence and UMCs will also be analysed.

Phase 2 introduces a Quality Improvement (QI) programme in collaboration with GP practices. This phase aims to identify and extract uncoded UMC data from free-text entries and discharge summaries in electronic health records to strengthen the accuracy and completeness of healthcare utilisation data.

Phase 3 will integrate the findings into a health economic model using a Individual-Level Simulation approach. The model will simulate patient pathways over time, accounting for adherence, asthma control, seasonal effects, and intervention uptake. Cost and outcome estimates will be analysed from an NHS perspective.

The ASTHMA study will generate evidence to support national policy and commissioning decisions regarding digital adherence technologies for asthma in children in primary care.

Study status

Planned
Research institutions and networks

Institutions

University of Sheffield

Networks

Contact details

Asghar Meerza

Primary lead investigator
Study timelines

Date when funding contract was signed

Actual:

Study start date

Planned:

Data analysis start date

Planned:

Date of final study report

Planned:
Sources of funding
EU institutional research programme

More details on funding

This research is funded by the University of Sheffield as part of the Wellcome Trust Public Health Economics PhD programme.
Study protocol
Initial protocol

Research Protocol.pdf

English (161.93 KB - PDF)View document
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

Not applicable