Status: Planned First registered on: 16/09/2019
Last updated on: 31/03/2020
1. Study identification
EU PAS Register NumberEUPAS31405
Official titleA 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
Study title acronymMAGNIFY
Study typeClinical trial
Brief description of the studyNot taking medications as prescribed is an issue affecting patients irrespective of disease and treatment type and can lead to poor clinical outcomes such as worsening symptoms. In COPD, guidelines have noted the importance of supporting patients with their regular inhaler use as part of COPD management. This study (MAGNIFY) will enable randomly selected GP practices to support COPD inhaler use in their patients through a new technology by Propeller Health (US). This technology includes a device which is attached to the Ultibro® inhaler, monitors inhalations and sends reminders to the user’s smartphone to take their daily dose. As part of this research, the device can be offered to suitable patients for 12 months. At the end of the study, researchers will assess the impact of the technology on clinical outcomes such as COPD exacerbations and medication use. Outside this research, the technology is currently available to healthcare providers in the UK through programs with Propeller Health with a range of inhalers. The study aims to recruit 176 GP practices in the UK and collect non-identifiable data from 2624 people. Half of the participating GP practices will be randomly selected to receive access to the technology. The other GP practices will continue their usual patient care. The study does not involve any visits outside usual care. Data will be extracted from the participating GP practices’ routine medical records at each site at the beginning of the study and regularly until the end of the study. All data will be stored in an ethically approved Optimum Patient Care Research Database (https://opcrd.co.uk). Any data shared with the researchers will be fully de-identified.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)? Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicableISRCTN Study ID: ISRCTN10567920 ADEPT Approval: ADEPT0719
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsOPRI Pte Ltd
Department/Research groupObservational and Pragmatic Research Institute Pte Ltd
Organisation/affiliationOPRI Pte Ltd
Website/Homepagewww.opri.sg
Details of (Primary) lead investigator
Title Professor
Last name Jones
First name Rupert
Is this study being carried out with the collaboration of a research network?
Yes

Optimum Patient Care (OPC)
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?176
Countries in which this study is being conducted
National study

United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed13/06/2019
Start date of data collection01/03/2020
Start date of data analysis
Date of interim report, if expected
Date of final study report15/12/2021
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesNovartis Pharma AG80
Charities
Government body
Research councils
EU funding scheme
OtherOPRI Pte Ltd20
5. Contact details for enquiries
Scientific Enquiries
Title Professor
Last name Jones
First name Rupert
Address line 1University of Plymouth
Address line 2N14, ITTC Building 
Address line 3Davy Road, 
CityPlymouth, Devon 
PostcodePL6 8BX 
CountryUnited Kingdom
Phone number (incl. country code)01752764403 
Alternative phone number 
Fax number (incl. country code) 
Email address rupert.jones@plymouth.ac.uk
Public Enquiries
Title Professor 
Last name Jones 
First name Rupert 
Address line 1University of Plymouth 
Address line 2N14, ITTC Building 
Address line 3Davy Road, 
CityPlymouth, Devon 
PostcodePL6 8BX 
CountryUnited Kingdom 
Phone number (incl. country code)01752764403 
Alternative phone number 
Fax number (incl. country code) 
Email address rupert.jones@plymouth.ac.uk 
Top