Exploring the Efficacy of myAsthma in Secondary Care

NCT04744272 | Withdrawn DMC

• 1 other identifier: MMH-R04
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Asthma is a common lung condition that causes long-term breathing problems. There is no cure and if uncontrolled can be life threatening. Many asthma deaths are preventable if managed using a personalised treatment plan explaining what to do when unwell, how to manage symptoms and correct inhaler use. Those with controlled asthma are less likely to be admitted to hospital and more likely to have an improved quality of life. COVID19 has emphasised the need to redesign healthcare delivery to reduce avoidable exposure. Clinical services are turning to remote care including online digital health apps. Digital health offers mechanisms to promote effective asthma care, offer remote individual treatment plans, monitor asthma control in 'real time' and provides information to prevent asthma attacks. Regulatory health guidelines recognise that technology has the potential to improve asthma care and could lead to reductions in NHS service use and improve symptoms. This study aims to evaluate the delivery of an asthma self-management app 'myAsthma' in a secondary care asthma service. Patients will use the app to input and track their symptoms and report their medication usage. The app provides information on environmental triggers such as air quality to better prepare asthma sufferers in preventing an asthma attack. It offers educational videos to improve understanding of asthma, including online training in inhaler technique. The goals are to increase adherence to and correct use of medication, help patients self-manage dynamically to reduce their risk of an asthma attack and equip healthcare professionals with the data to identify those people at higher risk of an attack. This is an unblinded randomised controlled trial with two arms: standard care (control) and myAsthma with standard care (intervention). Asthma control will be compared between the groups. It is a single-centre study which will take place in Bradford Teaching Hospital. A minimum of 60 participants will be recruited into the study and randomised on a ratio of 1:1 - 30 in the control arm and 30 in the intervention arm. Over 6 months outcomes will be measured using a combination of questionnaires and Asthma Control Test Scores (measure of symptom control). The main outcome of this study is to explore the efficacy of this new model of service delivery, whether it can provide an improvement in asthma control test scores, and will lead to a fully powered randomised controlled trial.

Conditions

Asthma

Keywords

Self-management; Digital Health

Outcome Measures

Primary Outcomes (1)

• Change in Asthma Control Test (ACT) scores

  A validated questionnaire for identifying poorly controlled asthma in adults. The ACT assesses the frequency of shortness of breath and general asthma symptoms, use of rescue medications, the effect of asthma on daily functioning, and overall self-assessment of asthma control. The scores range from 5 (poor control) to 25 (complete control), with higher scores reflecting greater asthma control. An ACT score \>19 indicates well-controlled asthma.

  ACT scores will be measured at months 0, 2, 4 and 6 to assess any change at each timepoint.

Secondary Outcomes (4)

• Assessment of Inhaler Technique using the UK Inhaler Group (UKIG) Standards and Competencies - 7 Steps

  Measured at months 0 and 6 to observe an improvement.

• Exacerbations

  Recorded at months 2, 4 and 6

• Change in EuroQol 5D-5L scores

  Measured at months 0 and 6

• myAsthma Patient Feedback (Intervention Arm)

  Measured at month 6

Study Arms (2)

Intervention

ACTIVE COMPARATOR

Participants randomised to the intervention arm will be provided with access to the digital web-based application (app) myAsthma.

Device: myAsthma

Control

NO INTERVENTION

Participants randomised to the control arm will continue with standard care processes

Interventions

myAsthma DEVICE

myAsthma is an online digital self-management application to support asthma patients by offering education, inhaler technique, pulmonary rehabilitation, symptoms and medication usage tracking remotely.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients over 18 years of age and able to give written informed consent
• A clinical diagnosis of Asthma on regular inhaled medication
• Any of the following measures of asthma control:
• Oral steroid use in the last 6 months
• ACT score \< 19
• Use of 6 or more short acting beta-agonist inhalers in the last 6 months
• Frequent symptoms and/or:
• ED or hospital admission for asthma in the last 6 months
• Patients on maintenance steroid therapy
• Patients on Biologics therapy
• Access to the internet at home, use of mobile technology and the ability to operate a web platform in English
• Consent to be contacted by telephone, text message and/or email

You may not qualify if:

• Asthma exacerbation in the past 2 weeks
• Patients who have other medical conditions, including but not limited to respiratory immunological or cardiac disease other than asthma deemed by the investigators as significant
• Diagnosis of Occupational Asthma
• Patients who are unable to read or use an internet-enabled device

Sponsors & Collaborators

• my mhealth Ltd: lead
• Bradford Teaching Hospitals NHS Foundation Trust: collaborator

Study Sites (1)

Bradford Teaching Hospitals NHS Foundation Trust, Bradford Institute for Health Research

Bradford, Yorkshire, BH1 1JU, United Kingdom

Location

Related Publications (30)

• Levy ML. National Review of Asthma Deaths (NRAD). Br J Gen Pract. 2014 Nov;64(628):564. doi: 10.3399/bjgp14X682237. No abstract available.

  PMID: 25348975 BACKGROUND

• "Global strategy for asthma management and prevention: GINA executive summary." E.D. Bateman, S.S. Hurd, P.J. Barnes, J. Bousquet, J.M. Drazen, J.M. FitzGerald, P. Gibson, K. Ohta, P. O'Byrne, S.E. Pedersen, E. Pizzichini, S.D. Sullivan, S.E. Wenzel and H.J. Zar. Eur Respir J 2008; 31: 143-178. Eur Respir J. 2018 Jan 31;51(2):0751387. doi: 10.1183/13993003.51387-2007. Print 2018 Feb. No abstract available.

  PMID: 29386342 BACKGROUND

• Asthma UK. Annual Asthma Survey 2019

  BACKGROUND

• Davis, K., Sissons B. Asthma and COVID-19: What to know. Medical News Today. 2020

  BACKGROUND

• Merchant R, Szefler SJ, Bender BG, Tuffli M, Barrett MA, Gondalia R, Kaye L, Van Sickle D, Stempel DA. Impact of a digital health intervention on asthma resource utilization. World Allergy Organ J. 2018 Dec 3;11(1):28. doi: 10.1186/s40413-018-0209-0. eCollection 2018.

  PMID: 30524644 BACKGROUND

• British Thoracic Society. Asthma guidelines 2016. British Thoracic Society (BTS). 2016

  BACKGROUND

• Mukherjee M, Stoddart A, Gupta RP, Nwaru BI, Farr A, Heaven M, Fitzsimmons D, Bandyopadhyay A, Aftab C, Simpson CR, Lyons RA, Fischbacher C, Dibben C, Shields MD, Phillips CJ, Strachan DP, Davies GA, McKinstry B, Sheikh A. The epidemiology, healthcare and societal burden and costs of asthma in the UK and its member nations: analyses of standalone and linked national databases. BMC Med. 2016 Aug 29;14(1):113. doi: 10.1186/s12916-016-0657-8.

  PMID: 27568881 BACKGROUND

• Trueman D, Woodcock F, Hancock E. Estimating the economic burden of respiratory illness in the UK. Br Lung Found 2014

  BACKGROUND

• Asthma UK and British Lung Foundation Partnership. Asthma facts and statistics ]. Asthma UK. 2020

  BACKGROUND

• Schultz K, Seidl H, Jelusic D, Wagner R, Wittmann M, Faller H, Nowak D, Schuler M. Effectiveness of pulmonary rehabilitation for patients with asthma: study protocol of a randomized controlled trial (EPRA). BMC Pulm Med. 2017 Mar 9;17(1):49. doi: 10.1186/s12890-017-0389-3.

  PMID: 28274210 BACKGROUND

• British Medical Association. The hidden impact of COVID-19 on patient care in the NHS in England 2020

  BACKGROUND

• Bussey-Smith KL, Rossen RD. A systematic review of randomized control trials evaluating the effectiveness of interactive computerized asthma patient education programs. Ann Allergy Asthma Immunol. 2007 Jun;98(6):507-16; quiz 516, 566. doi: 10.1016/S1081-1206(10)60727-2.

  PMID: 17601262 BACKGROUND

• Coffman JM, Cabana MD, Yelin EH. Do school-based asthma education programs improve self-management and health outcomes? Pediatrics. 2009 Aug;124(2):729-42. doi: 10.1542/peds.2008-2085. Epub 2009 Jul 27.

  PMID: 19651589 BACKGROUND

• Morrison D, Wyke S, Agur K, Cameron EJ, Docking RI, Mackenzie AM, McConnachie A, Raghuvir V, Thomson NC, Mair FS. Digital asthma self-management interventions: a systematic review. J Med Internet Res. 2014 Feb 18;16(2):e51. doi: 10.2196/jmir.2814.

  PMID: 24550161 BACKGROUND

• Hieftje K, Edelman EJ, Camenga DR, Fiellin LE. Electronic media-based health interventions promoting behavior change in youth: a systematic review. JAMA Pediatr. 2013 Jun;167(6):574-80. doi: 10.1001/jamapediatrics.2013.1095.

  PMID: 23568703 BACKGROUND

• Bunting BA, Cranor CW. The Asheville Project: long-term clinical, humanistic, and economic outcomes of a community-based medication therapy management program for asthma. J Am Pharm Assoc (2003). 2006 Mar-Apr;46(2):133-47. doi: 10.1331/154434506776180658.

  PMID: 16602223 BACKGROUND

• DiBello K, Boyar K, Abrenica S WP. The effectiveness of text messaging programs on adherence to treatment regimens among adults aged 18 to 45 years diagnosed with asthma: a systematic review. JBI Database Syst Rev Implement Reports. 2014;12(1):485-532.

  BACKGROUND

• de Jongh T, Gurol-Urganci I, Vodopivec-Jamsek V, Car J, Atun R. Mobile phone messaging for facilitating self-management of long-term illnesses. Cochrane Database Syst Rev. 2012 Dec 12;12(12):CD007459. doi: 10.1002/14651858.CD007459.pub2.

  PMID: 23235644 BACKGROUND

• Marcano Belisario JS, Huckvale K, Greenfield G, Car J, Gunn LH. Smartphone and tablet self management apps for asthma. Cochrane Database Syst Rev. 2013 Nov 27;2013(11):CD010013. doi: 10.1002/14651858.CD010013.pub2.

  PMID: 24282112 BACKGROUND

• Black AD, Car J, Pagliari C, Anandan C, Cresswell K, Bokun T, McKinstry B, Procter R, Majeed A, Sheikh A. The impact of eHealth on the quality and safety of health care: a systematic overview. PLoS Med. 2011 Jan 18;8(1):e1000387. doi: 10.1371/journal.pmed.1000387.

  PMID: 21267058 BACKGROUND

• Asthma UK. Delivering the Five Year Forward View : Behavioural change , information and signposting : Asthma UK consultation response Q1 ) How can we accelerate positive behavioural change towards prevention and self-care in the population and who should be responsi. 2015;1-7

  BACKGROUND

• Ofcom. Communications Marketing Report

  BACKGROUND

• Asthma UK. Connected asthma: how technology will transform care. 2016

  BACKGROUND

• Car J, Sheikh A. Telephone consultations. BMJ. 2003 May 3;326(7396):966-9. doi: 10.1136/bmj.326.7396.966. No abstract available.

  PMID: 12727771 BACKGROUND

• Car J, Sheikh A. Email consultations in health care: 1--scope and effectiveness. BMJ. 2004 Aug 21;329(7463):435-8. doi: 10.1136/bmj.329.7463.435.

  PMID: 15321902 BACKGROUND

• Car J, Sheikh A. Email consultations in health care: 2--acceptability and safe application. BMJ. 2004 Aug 21;329(7463):439-42. doi: 10.1136/bmj.329.7463.439.

  PMID: 15321903 BACKGROUND

• McLean S, Sheikh A. Does telehealthcare offer a patient-centred way forward for the community-based management of long-term respiratory disease? Prim Care Respir J. 2009 Sep;18(3):125-6. doi: 10.3132/pcrj.2009.00006. No abstract available.

  PMID: 19159046 BACKGROUND

• Al Moamary MS, Al-Kordi AG, Al Ghobain MO, Tamim HM. Utilization and responsiveness of the asthma control test (ACT) at the initiation of therapy for patients with asthma: a randomized controlled trial. BMC Pulm Med. 2012 Mar 26;12:14. doi: 10.1186/1471-2466-12-14.

  PMID: 22449144 BACKGROUND

• Schatz M, Kosinski M, Yarlas AS, Hanlon J, Watson ME, Jhingran P. The minimally important difference of the Asthma Control Test. J Allergy Clin Immunol. 2009 Oct;124(4):719-23.e1. doi: 10.1016/j.jaci.2009.06.053. Epub 2009 Sep 19.

  PMID: 19767070 BACKGROUND

• HRA & MHRA. Joint statement on seeking consent by electronic methods. 2018;(September):1-11

  BACKGROUND

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Tom Wilkinson

  my mhealth Ltd

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2021
• First Posted: February 8, 2021
• Study Start: May 1, 2022
• Primary Completion: January 1, 2023
• Study Completion: April 1, 2023
• Last Updated: October 28, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: Data will become available following a full statistical analysis. The aim is to provide open access
• Access Criteria: Open Access

Locations

GB (1)