AsthmaSTEERINGNCT04744272
Exploring the Efficacy of myAsthma in Secondary Care
A study testing myAsthma in people with Asthma, run by my mhealth Ltd at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- myAsthma
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2022to Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Bradford Teaching Hospitals NHS Foundation Trust, Bradford Institute for Health Research
Bradford, Yorkshire, BH1 1JU
About this study
Official title: A Randomised Controlled Feasibility Study to Explore the Efficacy of Digital Self-management Within Secondary Care in an Asthmatic Population
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.
Read more
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.
Read the detailed description
Asthma is a chronic highly prevalent condition, which results from inflammation and hyper-responsiveness of the airways resulting in variable airway limitation and symptoms of wheeze, cough, breathlessness and chest tightness. There is no cure for asthma, but the use of simple inhaler treatments can keep the symptoms under control. However, if uncontrolled, asthma can be life-threatening. Most deaths related to asthma are preventable if the condition is managed using the right treatment plan and inhaler technique.
In the UK, an estimated 4.3 million adults (1 in 12) receive treatment for asthma costing the NHS around £3 billion annually in direct and indirect care. Asthma accounts for approximately 60,000 hospital admissions per year. The NRAD states that a high proportion of patient morbidity is directly related to poor management. The annual 2016 asthma survey reported that 82% of asthma suffers said their asthma was poorly controlled. Those with uncontrolled asthma were almost twice as likely to be admitted to hospital. In the UK seven out of ten people with asthma received care that failed to meet basic quality standards with 30-70% reported as not taking their asthma medication as prescribed. Additionally, a significant proportion of patients do not use their inhalers as prescribed and demonstrate poor inhaler technique.
Since the arrival of COVID-19, it has never been more important for asthma suffers to ensure they are following their prescribed treatment plan. COVID-19 is a highly infectious virus that primarily affects the respiratory system, meaning those with asthma are at greater risk of severe complications. Maintaining consistent infection prevention practices and social distancing are key to minimising the risk of contracting the virus. However, social distancing and required 'lockdown' has impacted on routine clinic appointments, highlighting a lack of an alternative remote self-management system to support patients during this pandemic.
Systematic reviews have shown that despite the heterogenous interventions, technology enabled healthcare can improve process outcomes such as patient knowledge, self-management skills, improvement in inhaler technique and increased use of preventer medication. However, to date studies have shown an inconsistent effect on clinical outcomes such as symptoms, lung function, SABA use and quality of life. The use of technology enabled healthcare in asthma care has not identified significant harms or instances in which it was less effective than conventional care and results were encouraging enough to suggest further analysis of digital models of care.
Prior to COVID-19, the NHS model of care included a once annual asthma review. This has raised concerns that the full picture of asthma control may not be captured and is generally limited to the period around that review which is a fraction of the time people are living with asthma. Healthcare professionals aim to deliver best care and promote good asthma self-management, but this can be complex and time-consuming and so often not possible in the given time for primary care appointments, leading to adverse outcomes and variations in care.
Opportunities to address variations in care were identified in the NRAD. These included improving risk stratification to distinguish between those with asthma requiring minimal support through an annual review, and those who require closer monitoring throughout the year. Addressing safer prescribing to highlight those who have been prescribed excessive quantities of SABA inhalers, improving systems to arrange follow up, raising the quality of medical records and enabling systems to support asthma self-management.
In 2015, Asthma UK conducted a large survey to explore both asthma patients and healthcare professionals' views on mobile health (mHealth) requirements. They found that two-thirds of adult asthma sufferers had a smartphone suggesting that with the increasing presence of technology in homes, remote monitoring is becoming an alternative health service delivery option. The reported showed that almost three-quarters of patients would value an mHealth device to support asthma monitoring, and almost half would consider a system for use as part of an asthma action plan, to offer advice on medication and when to seek medical attention. Additionally, three-quarters of healthcare professionals stated an mHealth system which monitored asthma symptoms and provide asthma action plans would be beneficial.
Digital healthcare interventions are now more important than ever. They are able to support healthcare services to remotely deliver patient-centered care, facilitate timely access to health advice and medications, promote self-monitoring and medication compliance, and educate patients on trigger avoidance.
Evidence has shown that self-managed education, incorporating personalised asthma action plans improves health outcomes for people with asthma and reduces the use of healthcare resources particularly emergency department visits and hospital admissions. Furthermore, it can improve markers of asthma control, including reduced symptoms and has a positive effect on quality of life.
- Conditions
- Asthma
- Being tested
- myAsthma
- Keywords
- Self-management, Digital Health
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
myAsthmaDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | Participants randomised to the intervention arm will be provided with access to the digital web-based application (app) myAsthma. Receives: Device: myAsthma |
| Control | No intervention | Participants randomised to the control arm will continue with standard care processes |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Demonstrable improvement in inhaler technique from baseline to study completion using the UK Inhaler Group 7 competencies. The 7 competencies include procedures around device preparation, dose loading, inhaling and exhaling. A total of 0 errors equals appropriate inhaler technique.
Measured: Measured at months 0 and 6 to observe an improvement.
Exacerbations
Incidence of acute exacerbations, oral corticosteroid therapy and hospital admissions from baseline to study completion.
Measured: Recorded at months 2, 4 and 6
Change in EuroQol 5D-5L scores
Mean change in Quality of Life Ratings measured using EuroQol 5D-5L from baseline to study completion. The EQ-5D 5L measures health-related quality of life in adults. It is a standardised 5-dimensional instrument used to measure health outcomes. It comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems.
Measured: Measured at months 0 and 6
myAsthma Patient Feedback (Intervention Arm)
The my mhealth feedback questionnaire is based on the NHS Friends and Family Test (FFT) guidelines. This is an important feedback tool that supports the fundamental principle that people who use health services should have the opportunity to provide feedback on their experience. This is a short questionnaire consisting of multiple choice and semi structured questions. No scale is in place for this questionnaire.
Measured: Measured at month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2021
- Study startMay 2022 (estimated)
- Primary completionJan 2023 (estimated)
- Study completionApr 2023 (estimated)
Why it stopped: Delayed due to NHS pandemic pressures
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (30)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- my mhealth Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Bradford Teaching Hospitals NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Tom Wilkinson, Study director, my mhealth Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04744272
- Sponsor's protocol ID
- MMH-R04
- Acronym
- STEERING
- Status last verified
- Oct 2022
- First submitted
- 31 Jan 2021
- Last updated
- 28 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results will be disseminated in a journal publication
Publications
Levy ML. National Review of Asthma Deaths (NRAD). Br J Gen Pract. 2014 Nov;64(628):564. doi: 10.3399/bjgp14X682237. No abstract available.
PubMed 25348975"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.
PubMed 29386342Asthma UK. Annual Asthma Survey 2019
Davis, K., Sissons B. Asthma and COVID-19: What to know. Medical News Today. 2020
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.
PubMed 30524644British Thoracic Society. Asthma guidelines 2016. British Thoracic Society (BTS). 2016
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.
PubMed 27568881Trueman D, Woodcock F, Hancock E. Estimating the economic burden of respiratory illness in the UK. Br Lung Found 2014
Asthma UK and British Lung Foundation Partnership. Asthma facts and statistics ]. Asthma UK. 2020
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.
PubMed 28274210British Medical Association. The hidden impact of COVID-19 on patient care in the NHS in England 2020
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.
PubMed 17601262Coffman 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.
PubMed 19651589Morrison 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.
PubMed 24550161Hieftje 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.
PubMed 23568703
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Feasibility Study to Explore the Efficacy of Digital Self-management Within Secondary Care in an Asthmatic Population
- ClinicalTrials.gov ID
- NCT04744272
- Acronym / sponsor ID
- STEERING / MMH-R04
- Conditions
- Asthma
- Keywords
- Self-management, Digital Health
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Delayed due to NHS pandemic pressures
- Enrolment
- 0 participants (actual)
- Lead sponsor
- my mhealth LtdIndustry (pharma, biotech, devices)
- Collaborators
- Bradford Teaching Hospitals NHS Foundation Trust
- Study start
- May 2022 (estimated)
- Primary completion
- Jan 2023 (estimated)
- Study completion
- Apr 2023 (estimated)
- First posted
- 8 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Asthma is a chronic highly prevalent condition, which results from inflammation and hyper-responsiveness of the airways resulting in variable airway limitation and symptoms of wheeze, cough, breathlessness and chest tightness. There is no cure for asthma, but the use of simple inhaler treatments can keep the symptoms under control. However, if uncontrolled, asthma can be life-threatening. Most deaths related to asthma are preventable if the condition is managed using the right treatment plan and inhaler technique.
In the UK, an estimated 4.3 million adults (1 in 12) receive treatment for asthma costing the NHS around £3 billion annually in direct and indirect care. Asthma accounts for approximately 60,000 hospital admissions per year. The NRAD states that a high proportion of patient morbidity is directly related to poor management. The annual 2016 asthma survey reported that 82% of asthma suffers said their asthma was poorly controlled. Those with uncontrolled asthma were almost twice as likely to be admitted to hospital. In the UK seven out of ten people with asthma received care that failed to meet basic quality standards with 30-70% reported as not taking their asthma medication as prescribed. Additionally, a significant proportion of patients do not use their inhalers as prescribed and demonstrate poor inhaler technique.
Since the arrival of COVID-19, it has never been more important for asthma suffers to ensure they are following their prescribed treatment plan. COVID-19 is a highly infectious virus that primarily affects the respiratory system, meaning those with asthma are at greater risk of severe complications. Maintaining consistent infection prevention practices and social distancing are key to minimising the risk of contracting the virus. However, social distancing and required 'lockdown' has impacted on routine clinic appointments, highlighting a lack of an alternative remote self-management system to support patients during this pandemic.
Systematic reviews have shown that despite the heterogenous interventions, technology enabled healthcare can improve process outcomes such as patient knowledge, self-management skills, improvement in inhaler technique and increased use of preventer medication. However, to date studies have shown an inconsistent effect on clinical outcomes such as symptoms, lung function, SABA use and quality of life. The use of technology enabled healthcare in asthma care has not identified significant harms or instances in which it was less effective than conventional care and results were encouraging enough to suggest further analysis of digital models of care.
Prior to COVID-19, the NHS model of care included a once annual asthma review. This has raised concerns that the full picture of asthma control may not be captured and is generally limited to the period around that review which is a fraction of the time people are living with asthma. Healthcare professionals aim to deliver best care and promote good asthma self-management, but this can be complex and time-consuming and so often not possible in the given time for primary care appointments, leading to adverse outcomes and variations in care.
Opportunities to address variations in care were identified in the NRAD. These included improving risk stratification to distinguish between those with asthma requiring minimal support through an annual review, and those who require closer monitoring throughout the year. Addressing safer prescribing to highlight those who have been prescribed excessive quantities of SABA inhalers, improving systems to arrange follow up, raising the quality of medical records and enabling systems to support asthma self-management.
In 2015, Asthma UK conducted a large survey to explore both asthma patients and healthcare professionals' views on mobile health (mHealth) requirements. They found that two-thirds of adult asthma sufferers had a smartphone suggesting that with the increasing presence of technology in homes, remote monitoring is becoming an alternative health service delivery option. The reported showed that almost three-quarters of patients would value an mHealth device to support asthma monitoring, and almost half would consider a system for use as part of an asthma action plan, to offer advice on medication and when to seek medical attention. Additionally, three-quarters of healthcare professionals stated an mHealth system which monitored asthma symptoms and provide asthma action plans would be beneficial.
Digital healthcare interventions are now more important than ever. They are able to support healthcare services to remotely deliver patient-centered care, facilitate timely access to health advice and medications, promote self-monitoring and medication compliance, and educate patients on trigger avoidance.
Evidence has shown that self-managed education, incorporating personalised asthma action plans improves health outcomes for people with asthma and reduces the use of healthcare resources particularly emergency department visits and hospital admissions. Furthermore, it can improve markers of asthma control, including reduced symptoms and has a positive effect on quality of life.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Device: myAsthmaParticipants randomised to the intervention arm will be provided with access to the digital web-based application (app) myAsthma. |
| Control | No intervention | –Participants randomised to the control arm will continue with standard care processes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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:
- Frequent symptoms and/or:
- Access to the internet at home, use of mobile technology and the ability to operate a web platform in English
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| myAsthmamyAsthma is an online digital self-management application to support asthma patients by offering education, inhaler technique, pulmonary rehabilitation, symptoms and medication usage tracking remotely. | Device | Intervention |
Primary outcome
Change in Asthma Control Test (ACT) scores
Time frame: ACT scores will be measured at months 0, 2, 4 and 6 to assess any change at each timepoint.
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.
4 secondary outcomes
Assessment of Inhaler Technique using the UK Inhaler Group (UKIG) Standards and Competencies - 7 Steps
Time frame: Measured at months 0 and 6 to observe an improvement.
Exacerbations
Time frame: Recorded at months 2, 4 and 6
Change in EuroQol 5D-5L scores
Time frame: Measured at months 0 and 6
myAsthma Patient Feedback (Intervention Arm)
Time frame: Measured at month 6
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2022.
- Background: PubMed 25348975Levy ML. National Review of Asthma Deaths (NRAD). Br J Gen Pract. 2014 Nov;64(628):564. doi: 10.3399/bjgp14X682237. No abstract available.
- Background: PubMed 29386342"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.
- BackgroundAsthma UK. Annual Asthma Survey 2019
- BackgroundDavis, K., Sissons B. Asthma and COVID-19: What to know. Medical News Today. 2020
- Background: PubMed 30524644Merchant 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.
- BackgroundBritish Thoracic Society. Asthma guidelines 2016. British Thoracic Society (BTS). 2016
- Background: PubMed 27568881Mukherjee 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.
- BackgroundTrueman D, Woodcock F, Hancock E. Estimating the economic burden of respiratory illness in the UK. Br Lung Found 2014
- BackgroundAsthma UK and British Lung Foundation Partnership. Asthma facts and statistics ]. Asthma UK. 2020
- Background: PubMed 28274210Schultz 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.
- BackgroundBritish Medical Association. The hidden impact of COVID-19 on patient care in the NHS in England 2020
- Background: PubMed 17601262Bussey-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.
- Individual participant dataSharing planned: Yes. All IPD that underlie results will be disseminated in a journal publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tom Wilkinson study director
my mhealth Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing myAsthma in people with Asthma, run by my mhealth Ltd at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 28 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Asthma Control Test (ACT) scores (time frame: ACT scores will be measured at months 0, 2, 4 and 6 to assess any change at each timepoint.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04744272, which also lists 30 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2022.