ISRCTN10567920
Active, Not Recruiting
N/A
A pragmatic, cluster randomized trial evaluating the impact of an enhanced adherence package (dual bronchodilator + add-on + app) on time to treatment failure and other clinical outcomes in exacerbating COPD patients with poor adherence to mono or dual therapy over one year
Observational and Pragmatic Research International Ltd0 sites1,312 target enrollmentJuly 25, 2019
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Chronic obstructive pulmonary disease (COPD)
- Sponsor
- Observational and Pragmatic Research International Ltd
- Enrollment
- 1312
- Status
- Active, Not Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
2021 Protocol article in https://pubmed.ncbi.nlm.nih.gov/34079422/ (added 04/06/2021)
Investigators
Eligibility Criteria
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
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
Outcomes
Primary Outcomes
Not specified
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