Maximising Adherence and Gaining New Information For Your COPD v1

• Research type

  Research Study

• Full title

  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

• IRAS ID

  260690

• Contact name

  David Halpin

• Contact email

  d.halpin@nhs.net

• Sponsor organisation

  Observational and Pragmatic Research International Limited

• Clinicaltrials.gov Identifier

  n/a, ENCePP

• Duration of Study in the UK

  1 years, 9 months, 31 days

• Research summary

  Can technology improve the use of treatment and clinical outcomes in people with Chronic Obstructive Pulmonary Disease (COPD)?

  Not 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.

  The study is sponsored by OPRI and part funded by Novartis AG.

  Research results
  The study included patients with a lung problem called COPD, and explored whether offering them a support package resulted in better health outcomes over a one-year period. The support package included an inhaler, an add-on device that clipped onto the inhaler and, a mobile phone app that gave information about their inhaler use. Compared to patients who were not offered the support package, patients who accepted the package had fewer problems with their COPD over the next year e.g. flare ups of their symptoms, needing extra medication or death. Patients most likely to benefit from the support package seemed to be those with worse COPD and those that did not have flare ups of their symptoms in the year before they started the study

• REC name

  East Midlands - Derby Research Ethics Committee

• REC reference

  19/EM/0238

• Date of REC Opinion

  6 Nov 2019

• REC opinion

  Further Information Favourable Opinion