MAGNIFY

Maximising Adherence and Gaining New Information for Your COPD

MAGNIFY is a large innovative pragmatic cluster randomised trial, currently recruiting new primary care practices in UK. This is a low intervention study to investigate whether adherence support can improve COPD outcomes in real life in the UK. No study visits or patient consents are required, and randomisations will be done at the practice rather than patient level.

To take part or for more information contact the MAGNIFY team at magnify@opri.org.uk or 01223 967855. Alternatively, contact your local CRN for more information.

Study Summary

The population Adults with COPD who are experiencing exacerbations and have poor adherence.
The intervention An adherence support package including dual bronchodilator add-on device and an app for patient’s mobile phone.
Comparison group Usual Care
Primary outcomes Time to treatment failure, defined as the first occurrence of:
1. Moderate/severe COPD exacerbation
2. Prescription of triple therapy (ICS/LABA/LAMA)
3.Prescription of additional chronic therapy
4.Respiratory-related death
Secondary outcomes 1. Adherence (based on prescription (Rx) refill records over 12 months)
2. Moderate/severe exacerbations (in terms of the proportion of patients with at least one moderate/severe exacerbation at 12 months, and total number of exacerbations at 12 months)

Background

It is believed that poor adherence to prescribed medications is high in patients with Chronic Obstructive Pulmonary Disease (COPD), this can be attributed to several factors, including:

  1. Forgetting to take medication
  2. Patient’s own perception of their disease and concerns over the effectiveness of the drugs
  3. Incorrect use of inhalers (e.g. poor technique)

NICE guidelines have noted the importance of supporting patients with their regular inhaler use as part of COPD management. Non-adherence to prescribed medications can lead to poor clinical outcomes for patients, such as:

  1. More symptoms, impaired quality of life and faster disease progression
  2. More exacerbations and hospitalisations
  3. Over-estimated dosing requirements

In addition, poor adherence can incur substantial costs and medicine waste.

Electronic reminders and monitoring have been used in several disease conditions to improve medication adherence. The potential of mobile phone technology to improve the quality and delivery of health care, including diagnosis, treatment adherence, and data collection has been recognised (Free et al. 2013). Accurate, easily understood and personally relevant feedback is clearly relevant to many patients in this process.

MAGNIFY will enable GP practices to support regular inhaler use through a new technology provided by Propeller Health (US). This technology includes a device which is attached to the glycopyrronium / indacaterol Ultibro® inhaler. This device monitors inhalations and sends reminders to the user’s smartphone to take their daily dose. The study aims to determine whether the use of adherence support technology will improve outcomes in COPD patients with poor adherence to treatment.

What We'll Be Doing

Aim

Evaluating the impact of an enhanced adherence support package (dual bronchodilator inhaler and adherence technology device with mobile phone app) on time to treatment failure and other clinical outcomes in exacerbating COPD patients with poor adherence to current mono or dual therapy over one year.

Study Design

MAGNIFY is a pragmatic, cluster randomised, multicentre implementation study that will be completed over one year.

Participating practices will be randomised to one of two arms:

  1. Adherence support arm – provision of adherence support technology devices. This will take place at routine COPD reviews
  2. Standard care arm – continue usual routine clinical care, there are no study visits

De-identified Electronic Medical Record (EMR) data collected from all participating practices by Optimum Patient Care (OPC) will be used to assess clinical outcomes.

Study Population

It’s estimated that MAGNIFY will need approximately 176 practices to partake (about 88 per arm), or enough practices to provide information for 2600 patients.

Key Criteria for Practices

Inclusion Criteria

  • General practice in the United Kingdom (England, Scotland, Wales, Northern Ireland).
  • Participating in Optimum Patient Care Quality Improvement Programme that support chronic disease review and provide high quality respiratory data.
  • Willing to use advanced technology as part of clinical practice.
  • At least 8 patients suitable for adherence technology.
  • Actively prescribing Ultibro® Breezehaler® as a routine clinical care option; (i.e. inhaler compatible with the add-on technology).

Exclusion Criteria

  • General practice not prescribing Ultibro as part of routine clinical care to patients with COPD.
  • General practices hosting or affected by research, or other aspects of care, which might significantly influence the practice-wide implementation.

Key Criteria for Participants

Inclusion Criteria

  • Aged ≥40 years
  • Ever-smoker
  • On the COPD register of participating practices
  • Coded COPD diagnosis and FEV1/FVC ever recorded <0.7
  • At least 2 moderate/severe COPD exacerbations in the last 24 months
  • Total adherence to current mono/dual therapy of 50% based on refill Rx data in the last 12 months

Exclusion Criteria

  • Patients with a consent refusal code indicating opt-out of data used for research
  • Patients not deemed clinically appropriate for the therapy which is technology compatible
  • Patients on triple therapy (ICS/LABA/LAMA)
  • Read code for asthma
  • Blood eosinophil count >300 cells/μl if blood count available in the last 12 months
  • Unable to use technology (e.g. not having/able to use a smartphone compatible with the technology, not having reliable Internet access)

Approvals

  • REC reference: 19/EM/0238
  • ADEPT ADEPT0719
  • CPMS Identifier: 42625
  • IRAS ID: 260690
  • ENCePP reference number: EUPAS31405

The study has been adopted by the NIHR and support is available from your local CLRN.

Find out more about the adherence technology device from Propeller Health.

MAGNIFY is an ideal study for research naive practices.

Find out about the benefits of taking part in the Quality Improvement Programme while taking part in MAGNIFY.

For more details on data management and information governance please visit OPC’s Data Security and Protection page.

MAGNIFY Team and Steering Committee

Experts contributing to national guidelines (NICE), international COPD strategies (GOLD) and UK primary care, form the MAGNIFY study investigators:

Name and role
Professor David Price
Chief Investigator

Professor Price is Primary Care Respiratory Society Professor of Primary Care Respiratory Medicine at the University of Aberdeen (UK). He was awarded Fellow of ERS (FERS) in 2016. He is also a member of the World Health Organization (WHO) Allergic Rhinitis and its Impact on Asthma (ARIA) executive committee, the World Allergy Organization (WAO), Committee on Asthma, and the WAO Education Council.

Professor Price was the founding president of the Respiratory Effectiveness Group (http://www.effectivenessevaluation.org/), a not-for-profit, investigator-led initiative which uses an international collaborative approach to explore the optimum role of real-life research in informing clinical guidelines and improving patient care.

Professor Price completed his medical degree at Cambridge University in 1984. He was previously Affiliate Associate Professor in the Department of General Practice at the University of Adelaide, Australia and held an Honorary Chair at the University of East Anglia, UK.

He is extensively involved in respiratory and allergy research; his areas of special interest are the ‘real-life’ effectiveness and cost-effectiveness of interventions, clinical trial design, adherence, and patient attitudes to their disease. He has authored more than 490 peer-reviewed publications and is responsible for approximately US$50 million in research and clinical development grants. He is currently Editor-in-Chief of the journal Pragmatic and Observational Research and member of the editorial board of several respiratory journals, including The Lancet Respiratory Medicine.

Dr. Rupert Jones
Chief Investigator

Dr Rupert Jones is a Senior Clinical Research Fellow at the Peninsula School of Medicine, Plymouth. With a background of 30 years in general practice and a special interest in respiratory medicine, he continues to work in the Derriford hospital chest clinic as a locum consultant. He is the founding co-director of the Makerere University Lung Institute in College of Health Sciences in Kampala.

Dr Rupert Jones is a senior researcher at the Observational & Pragmatic Research Institute in Singapore and has been involved in the design development of conduct and reporting of many database studies including pharmacoepidemiology, and the diagnosis and management of COPD and asthma.

He is chair of the scientific committee of the Salford Lung study, which is the world’s first pre-registration pragmatic randomised controlled trial (RCT) comparing Relvar with usual care in a real-life setting, published in The New England Journal of Medicine and The Lancet in 2017. He also established the National COPD Audit in UK with Prof Mike Roberts.

Working with health psychologists, Dr Rupert Jones designed and validated:

  • The Lung Information Needs Questionnaire which is referenced in international guidelines and is translated into 18 languages. (www.linq.org.uk).
  • The DOSE index, a multicomponent COPD severity assessment tool, used in clinical practice and international research. The index is cited in leading international guidelines.
  • The Severe Asthma Questionnaire (www.saq.org.uk) which is being developed for use in clinical practice, research and clinical trials.
Dr. Kai Beeh

Kai Michael Beeh, MD studied medicine and the history of arts in Frankfurt, Germany. He was trained in clinical skills at Mainz University Hospital (Depts. of Hematology/Oncology, Pulmonary Medicine, Cardiology and Critical Care) from 1997 to 2004 and received board certifications in Internal Medicine (2003) and Pulmonary Medicine (2004).

In 2004, Dr. Beeh received the venia legendi from the medical faculty of Mainz University and serves as adjunct Professor ("Privatdozent") of Medicine.

Dr. Beeh was awarded the Merck, Sharp & Dohme grant "Asthma" in 1999 and spent several months of basic research at the Department of Thoracic Medicine, National Heart and Lung Institute, Imperial College, London, UK (Prof. P.J. Barnes) in 2000.

Dr. Beeh has designed and conducted over 100 clinical trials in asthma, COPD and rhinitis as Principal Investigator or Clinical Trial Leader (LKP) according to german drug law (AMG).

2015 he received a degree in Market Access Management from the European Business School (EBS) in Oestrich-Winkel.

He is a consultant and advisor to several international biomedical companies and the pharmaceutical industry.

Dr. Beeh has published or co-authored over 100 peer-reviewed articles on inflammation and pharmacotherapy of inflammatory airway diseases. He is Editor of "Pulmonary Therapy" and peer-reviews scientific articles for New England Journal of Medicine, Lancet, American Journal of Respiratory and Critical Care Medicine, European Respiratory Journal and others.

He has edited a textbook monography on COPD Exacerbations in 2014 and is author of the international popular non-fiction Book "The breathtaking World of the Lungs" published by Random House in 2018.

Dr. Beeh is a member of the German Society of Pneumology and the German Society for Market Access (DFGMA).

Professor James Chalmers

Prof. James Chalmers is a Professor and Consultant Respiratory Physician at the School of Medicine, University of Dundee. His laboratory works primarily on the interaction between neutrophils and bacteria during acute and chronic airway infections. Major areas of research with relevance to AMR include phase 1 and phase 2 studies of non-antibiotic alternative therapies for respiratory infections, the development of diagnostics to reduce antibiotic use by more accurately identifying bacterial infections and work to understand the selective drivers of antimicrobial resistance in chronic airways diseases such as bronchiectasis and cystic fibrosis where multidrug resistant Gram-negative infections are common. His work is funded by the Wellcome Trust, Medical Research Council, Scottish Government, EU and the pharmaceutical industry.

Dr. Allan Clark

Dr Allan Clark is a statistician with an interest in the application of statistical methods to clinical trials, mainly in stroke and respiratory diseases.

Professor David Halpin

Professor Halpin trained at Oxford & St Thomas Hospital Medical School: completing a D.Phil. in the Department of Human Anatomy, Oxford, before finishing his clinical training at St Thomas. He completed his postgraduate training in respiratory medicine at the Brompton Hospital.

Professor Halpin is a Fellow of Royal College Physicians, Member British Thoracic Society, European Respiratory Society & American Thoracic Society.

Professor Halpin continues to undertake research in respiratory medicine & has published widely. He lectures frequently around the world on COPD.

Until recently Professor Halpin was an Associate Editor of Thorax.

Professor Halpin is one of the 10 Directors of the WHO/NIH Global Initiative for Obstructive Lung Disease (GOLD) and a member of the GOLD Science Committee.

Professor Halpin was the Chairman and Clinical Expert for the COPD Guideline Development Group of the National Institute of Clinical Excellence (NICE) in the UK.

Until 2015 Professor Halpin was also Respiratory Clinical Lead for the NHS in the South West.

Dr. Alan Kaplan

Dr Alan Kaplan is a Family Physician working in York Region, Ontario, Canada and the Chairperson of the Family Physician Airways Group of Canada (www.fpagc.com), the Past- Chairperson of the Respiratory Section of the College of Family Physicians of Canada, and Senate member of the International Primary Care Respiratory Group. He co-chaired the Community Standards of COPD program for Health Quality Ontario. He is the medical director of the Pulmonary Rehabilitation program for the local health integration network.

Dr. Konstantinos Kostikas

Dr. Kostikas is Respiratory Physician with long-standing clinical and research experience in different Greek and international setting (academic, clinical, research and industry), with excellent skills in communication, patient management, publication planning and study design and execution.

Dr. Kostikas has been involved in several posts of the European Respiratory Society (ERS), including HERMES Examination Committee and the role of Learning Resources Director. Dr. Kostikas’ research activities focus on asthma and COPD (biomarkers, phenotyping, comorbidities and exacerbations). Dr. Kostikas is a member of the Editorial Board of PLoS ONE, and peer reviewer for all major respiratory journals. Dr. Kostikas has more than 170 publications in PubMed (over 3,300 citations and h-index 29) and contributed several chapters to medical textbooks, focusing on asthma, COPD and biomarkers.

Dr. Hilary Pinnock

Hilary is Professor of Primary Care Respiratory Medicine at The University of Edinburgh and plays a key role at the Asthma UK Centre for Applied Research. A practicing primary care doctor, her research interests focus on the delivery of respiratory care within the real-life primary care setting.

Professor Hilary Pinnock has been elected as Head of Assembly 1 - General Pneumology at the European Respiratory Society (ERS).

Professor Nicolas Roche

Nicolas Roche is Professor of Respiratory Medicine at Cochin Hospital, University of Paris Descartes, Paris, France. He graduated in medicine in 1994 and obtained his PhD in 2003. He spent a year as a research fellow at Imperial College London, London, UK. His major areas of interest are chronic obstructive pulmonary disease (COPD), asthma, inhaled therapy and real-life research.

Professor Roche coordinates epidemiological research projects as well as a dedicated nationwide clinical research group. His clinical research topics include the study of disease phenotypes, the development of new clinical assessment tools and the evaluation of treatment strategies for COPD and asthma.

He is involved in national public health initiatives on COPD. He participated in the development of French guidelines on asthma and education of asthmatic adults, coordinates the French guidelines on COPD. He is a member of the Global Initiative on Obstructive Lung Disease science committee and the executive committee of the Respiratory Effectiveness Group.

Professor Roche has authored more than 250 articles in international peer-reviewed journals and edited or co-edited several books on COPD, including articles on inhalation therapy for asthma and COPD. He is Vice-President of Société de Pneumologie de Langue Française, member of the Clinical Research Collaboration working group of the European Respiratory Society and member of the American Thoracic Society. He has been Chief Editor of Revue des Maladies Respiratoires and is Associate Editor of the European Respiratory Review and the Clinical Respiratory Journal.

Dr. Omar Usmani

Omar Usmani MB BS, PhD, FHEA, FRCP, is Reader in Respiratory Medicine and Consultant Physician at the National Heart and Lung Institute (NHLI), Imperial College London & Royal Brompton Hospital (RBH).

He is an International Authority on Aerosol Science and Inhalation Medicine whose research has fundamentally contributed to the understanding of therapeutic aerosol deposition and clinical effectiveness in inhaled drug delivery to the lungs.

In 2015, he was awarded one of the highest accolades in Aerosol Science, the Thomas T Mercer Award from the American Association of Aerosol Research (AAAR) and the International Society of Aerosols in Medicine (ISAM), recognising his International Research Excellence in Pharmaceutical Aerosols and Inhalable Materials.

Dr. Omar Usmani’s Clinical Specialist Interests are Asthma, COPD and Chronic Cough. He is Group Leader of the Clinical Research Group within the Airway Disease Section at NHLI and a Principal Investigator. He is part of the Consultant-led RBH specialist Chronic Cough Service.

In 2012, Dr Usmani was awarded a UK - National Institute for Health Research (NIHR) Career Development Fellowship to investigate the lung deposition behaviour of inhaled bronchodilator aerosols of different particle size within the airways of patients with Chronic Obstructive Pulmonary Disease (COPD). This was the first time this award category was given to Respiratory Science research in the UK.

In 2017, Dr Usmani was elected to the world's largest respiratory society as ERS Secretary of Assembly 5 - Airway Diseases. He also became Chair of the UK Inhaler Group (UKIG), having taken over the role from Monica Fletcher OBE.

In 2016, he was appointed to lead and chair the second updated version of the International ERS/ISAM Taskforce Consensus Statement on "What the pulmonary physician should know about inhaled therapy".

Dr. Job van Boven

Dr. Job van Boven is an expert in health economics (e.g. cost-effectiveness, burden of disease) and real-world drug outcomes (e.g. (pharmaco)epidemiology, medication adherence, compliance, persistence), mainly applied to lung diseases (asthma, COPD, TB, lung cancer).

References

Free, C., G. Phillips, L. Watson, L. Galli, L. Felix, P. Edwards, V. Patel, and A. Haines. 2013. ‘The effectiveness of mobile-health technologies to improve health care service delivery processes: a systematic review and meta-analysis’, PLoS Med, 10: e1001363.