Maximising Adherence and Gaining New Information For Your COPD (MAGNIFY)

Not Applicable

• Conditions: Chronic obstructive pulmonary disease (COPD); Respiratory

• Registration Number: ISRCTN10567920
• Lead Sponsor: Observational and Pragmatic Research International Ltd

Brief Summary

2021 Protocol article in https://pubmed.ncbi.nlm.nih.gov/34079422/ (added 04/06/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-07-25
• Last Update Posted: 27 February 2024
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 1312

Inclusion Criteria

Current inclusion criteria as of 06/09/2023:
For a practice to be eligible for participation, the following criteria should be met:
1. General practice in the United Kingdom (England, Scotland, Wales, Northern Ireland) participating in Optimum Patient Care services that support chronic disease review and provide high-quality respiratory data
2. Willing to use advanced technology as part of clinical practice
3. At least 8 patients suitable for adherence technology
4. Actively prescribing Ultibro® Breezehaler® as a routine clinical care option; (i.e. inhaler compatible with the add-on technology)

Patients suitable for adherence technology support:
1. Aged =40 years
2. Ever-smoker
3. On the COPD register of participating practices
4. Coded COPD diagnosis and FEV1/FVC ever recorded <0.7
5. At least 2 moderate/severe COPD exacerbations in the last 24 months (or prior to March 2020, if poorer)
6. Total adherence to current mono/dual therapy of =50% based on refill Rx data or a clinical EHR code for poor adherence in the last 12 months (or prior to March 2020, if poorer)

Previous inclusion criteria:
For a practice to be eligible for participation, the following criteria should be met:
1. Willing to receive OPC clinical audit and quality improvement services, including IT access for secure software installation and de-identified data extraction
2. Willing to use adherence technology as part of clinical practice
3. At least 16 patients suitable for adherence technology support (see below)
4. A clinician (doctor, nurse, pharmacist, etc) willing to act as a practice lead
5. Prescribing or able to prescribe Ultibro® Breezehaler® as a routine clinical care option i.e. inhaler compatible with the add-on technology

Patients suitable for adherence technology support:
1. Confirmed COPD diagnosis
2. Smoking history
3. At least 2 COPD exacerbations in the last 24 months
4. Poor adherence to single/dual COPD therapy – Total adherence to current mono/dual therapy of =50% based on refill Rx data in the last 12 months

Exclusion Criteria

Current exclusion criteria as of 06/09/2023:
Practice exclusion criteria:
1. General practice not prescribing Ultibro® as part of routine clinical care to patients with COPD
2. General practices hosting or affected by research, or other aspects of care, which might significantly influence the practice-wide implementation

Patient exclusion criteria:
1. Patients with a consent refusal code indicating opt-out of data used for research
2. Patients not deemed clinically appropriate for the therapy which is technology-compatible
3. Patients on triple therapy (ICS/LABA/LAMA)
4. Read code for asthma (excluding ‘asthma resolved’ read codes)
5. Blood eosinophil count >300 cells/µl if blood count available in the last 12 months
6. Unable to use technology (e.g. not having/able to use a smartphone compatible with the technology, not having reliable Internet access)

Previous exclusion criteria:
GP Practice who cannot prescribe Ultibro breezhaler or currently do not prescribe Ultibro breezhaler

Study & Design

• Study Type: Interventional
• Study Design: Not specified