AsthmaIDEALNCT03511482
Integrated Digitally Enhanced Care for Long-term Conditions- Asthma
A study testing myAsthma Application and Lloyds Pharmacy Online Doctor 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 difficulties. There is currently no cure for asthma but the use of simple inhaler treatments can keep the symptoms under control. If asthma symptoms get worse this can lead to an asthma attack which can be life-threatening. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Asthma
- What is being tested?
- myAsthma Application and Lloyds Pharmacy Online Doctor
- 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
- 8 Mar 2019to 31 Mar 2021
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients aged 18 years and over
- Able to give written informed consent
- A clinical diagnosis of Asthma on regular inhaled medication
- Measures of poor asthma control: Oral steroid use in the last 12 months and /or ACT score of less than 20 at screening, and/or use of 6 or more short acting beta-agonist inhalers in the last 6 months and/or frequent symptoms and/or (Accident and Emergency) A+E or hospital admission for asthma
- Access to the internet at home, use of mobile technology and the ability to operate a web platform in English
- No plans to travel abroad for prolonged periods during the trial period
- Consent to be contacted by phone, text and email
Who cannot join
- Asthma exacerbation in the past 4-6 weeks (Baseline visit to be delayed)
- . Patients who have a significant medical comorbidity that can present with asthma type symptoms e.g. COPD, Heart Failure, Lung Cancer (these cases require physical examination and a remote assessment would not be appropriate)
- Terminal Illness Pregnant
- Breast Feeding
- Patients who have another medical condition, including but not limited to respiratory immunological or cardiac disease other than asthma deemed by the investigators as significant
- Diagnosis of Occupational Asthma
Show all 14Show fewer
- Patients on long term oral steroids or theophylline, as these treatments are not provided by the online doctor service
- Previous Intensive Therapy Unit (ITU) admission for asthma
- Patients under routine follow up of secondary care for asthmaHousebound
- Patients who are unable to read or use an internet-enabled device
- Alcohol and drug misuse
- Patients deemed unsuitable by their GP
- Patients who have another medical treatment(s), including but not limited to beta blockers deemed unsuitable by the investigators.
- Already using a self management app.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
my mhealth Limited
Bournemouth, Hampshire, BH1 1JU
About this study
Official title: An Open Feasibility Study to Investigate the Impact of A Digitally Delivered Asthma Service for Patients in Primary Care (IDEAL-001: Integrated Digitally EnhAnced Care for Long-term Conditions-001
Asthma is a common lung condition that causes long term breathing difficulties. There is currently no cure for asthma but the use of simple inhaler treatments can keep the symptoms under control. If asthma symptoms get worse this can lead to an asthma attack which can be life-threatening. It has been shown that most of the deaths related to asthma are preventable if asthma is managed using the correct treatment plan however a significant proportion of patients are not using the right inhalers or not using them properly and do not know how to manage their asthma if it gets worse.
There is currently an unmet need to develop tools that can help improve asthma care, identify high risk patients, closely monitor their asthma control in 'real time' and intervene to optimise treatment to prevent asthma attacks. Both patients and indeed, the current British Thoracic Society (BTS) asthma guidelines recognise that technology has the potential to be used to improve asthma care and could lead to reductions in National Health Service (NHS) services use and improvements in symptoms.
Read more
Patients with better controlled asthma are less likely to be admitted to hospital and more likely to have an improved quality of life. This study aims to evaluate the delivery of an asthma service using an online doctor providing remote consultations paired with a self-management asthma app. The patients will use the app to input and track their symptoms, which will be monitored by a doctor remotely who can provide advice, optimise medications and intervene in a timely manner to prevent an asthma attack. The service is interactive, so the patient and doctor can communicate with one another 7 days a week by completing a consultation or sending messages via the online doctor portal or speaking on the telephone. The app will relay information about environmental triggers to the patient to help prevent the patient's asthma getting worse. The service will provide a new and potentially more convenient way of delivering routine appointments to reduce the numbers that do not attend. The patients will be able to watch educational videos stored on the app about asthma to potentially improve understanding of their condition. Digital training in inhaler technique will be supported with face to face support from pharmacists.
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 (with solutions personalised to an individual's triggers) and equip healthcare professionals with the data to identify those people at higher risk of an attack.
This is a before-and-after open interventional study, which means participants' asthma control will be compared before and after using the digital asthma management service. It is not a randomised study and participants will be given the choice of using a digital service. It is a single-centre study which will take place within one Clinical Commissioning Group (CCG) in Hampshire (UK), across at least two GP surgeries. It is anticipated that approximately 80 patients will be recruited.
Patients will be provided with this digital asthma service for a period of 6 months of 2018 and outcomes will be measured using a combination of questionnaires (quality of life, patient satisfaction, level of activation) and quantitative measures such as Forced Expired Volume over 1 second (FEV1)(measure of airway obstruction), Fractional Exhaled Nitric Oxide (FENO) (measure of airway inflammation) and Asthma Control Test Scores (measure of symptom control). Feedback from NHS professionals hosting the study and online doctors will also be sought. A Health economic model will be generated comparing the digitally enhanced model versus usual care. The main outcome of this study is looking at whether this new model of service delivery can provide an improvement in asthma control test scores.
Read the detailed description
Asthma is a 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. 4.3 million adults (1 in 12) in the UK are currently receiving treatment for asthma. Treatment usually involves a combination of reliever and preventative inhaler therapy. On average 3 people a day die from asthma. The National Review of Asthma Deaths (NRAD) has shown that much of the morbidity relates to poor management particularly around the use of preventative treatment concluding that two-thirds of asthma deaths were preventable.
We have a well-established evidence base of how to help control asthma and prevent attacks using interventions that focus on maintaining control and reducing risk of an attack. However, there are concerns that the current National health Service (NHS) model of care: a once annual asthma review may not capture the full picture of asthma control 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 the best care and motivate good asthma self-management, but this can be complex and time-consuming and so often is not possible in the allotted time for primary care appointments, leading to adverse outcomes and to variation in care.
Opportunities to address this variation 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, ensuring safer prescribing to highlight where people with asthma have been prescribed excessive quantities of Short Acting Beta Agonist (SABA) inhalers, improving systems to arrange follow up, raising the quality of medical records and enabling systems to support asthma self-management.
The NHS spends around 1 billion a year treating and caring for people with asthma. Asthma accounts for about 60,000 hospital admissions per year. The annual 2016 asthma survey reported an overwhelming majority of patients, 82%, said their asthma was poorly controlled. Almost half of respondents said their asthma interfered with their day to day life and 46% said they had difficulty sleeping due to their asthma symptoms. Those with uncontrolled asthma were almost twice as likely to be admitted to hospital as those whose asthma symptoms were under control. The majority of patients admitted to hospital did not receive follow up putting them at higher risk of future attacks and re-admission to hospital. In the United Kingdom (UK) seven out of ten people with asthma receive care that fails to meet basic quality standards with 30-70% reported as not taking their asthma medication as prescribed.
With 85% of asthma patients being managed exclusively in primary care, asthma is estimated to account for around 2-3% of General Practitioners (GP) consultations19, costing an estimated £108 million annually. As highlighted by the recent General Practice Five Year Forward View, with an ever-increasing burden on services, conventional models of care are constantly being challenged and alternative, cost-effective ways of delivering healthcare to a larger cohort of patients are being sought.
Digital healthcare interventions may help to address some of these challenges by enabling remote delivery of patient-centred care, facilitating timely access to health advice and medications, prompting self-monitoring and medication compliance, and educating patients on trigger avoidance.
Telemonitoring, the transmission of monitoring data from a patient to an electronic health record which is shared with and monitored by healthcare professionals has the potential to improve outcomes. The impact of telemonitoring is likely to be strongly influenced by the level of professional support provided and personalisation of feedback. Studies have shown that people with poorly-controlled asthma have the potential to gain more by engaging with telemonitoring, helping people recognise worsening control and take preventative action to reduce their risk of an attack early. There is a substantial body of evidence to show that self-management education incorporating written personalised asthma action plans improves health outcomes for people with asthma. Self-management education reduces emergency use of healthcare resources including Accident and Emergency department visits and hospital admissions and improves markers of asthma control, including reduced symptoms and days off work and improved quality of life. Internet technology might offer an attractive means for encouraging patients to use self-management strategies within a day-to-day context.
In 2015, two thirds of patients with asthma had a smartphone, and with this ever-increasing presence of technology in homes, online prescribing and remote monitoring is beginning to emerge as an alternative way of delivering services. Nearly three-quarters of patients wanted to see an mHealth device that would help them monitor their asthma and nearly half would value a system which could be used as part of their asthma action plan and advise them if changes to medication have improved their asthma and when to seek medical attention. Three-quarters of healthcare professionals said they would value an mHealth system that would monitor patients' asthma symptoms over time and provide patients with an asthma action plan.
Systematic review has shown that despite the heterogenous interventions, technology enabled healthcare can improve process outcomes such as knowledge adherence to monitoring, 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 computerised decision support systems need to align better with professional workflows so that pertinent and timely advice is easily accessible within the consultation. Evidence to support asynchronous remote consulting suggests that it leads to reductions in healthcare usage and disease status although evidence is very limited and of low quality in this patient group.
Systematic review of 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 the studies in asthma patients gave results encouraging enough to suggest further analysis of digital models of care. To the best of our knowledge, this is the first study looking at an integrated approach of using a self-management app, telemonitoring and asynchronous remote consulting in asthma patients.
- Conditions
- Asthma
- Being tested
- myAsthma Application, Lloyds Pharmacy Online Doctor
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
myAsthma ApplicationDevice
myAsthma Application is a Multi facetted online self management tool developed by my mhealth Ltd, which is an online interface for patient to feedback symptoms and (Quality of Life) QoL score. The app consists of an online action /self management plan, Patient education videos, medication diary, Peak Flow diary, Inhaler technique videos, mindfulness videos as well as weather and Pollution forecasters.
Lloyds Pharmacy Online DoctorDevice
Online Doctor is part of Expert Health Ltd a doctor-led initiative providing safe and reliable remote online healthcare to adults in the UK. Their patient-centred model of healthcare allows patients to tailor care around their schedule and increases healthcare access for harder-to-reach patient groups.
As the first ever online healthcare organisation to register with the government regulator of healthcare - and having received outstanding feedback from the Care Quality Commission about the high level of safe, effective, caring, responsive and well led care provided by the service - They pride themselves on their pioneer status and work constantly to expand the boundaries of personalised healthcare.
| Study group | Role | What they receive |
|---|---|---|
| MyAsthma Application and Lloyds Pharmacy Online Doctor | Experimental | Web based applications to support people with Asthma management Receives: Device: Lloyds Pharmacy Online Doctor |
| MyAsthma Application and Usual care | Experimental | Web based application to support people with Asthma Management Receives: Device: myAsthma Application |
| Usual care only (control) | No intervention | Usual care of asthma management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Asthma Control Test (ACT)
The ACT is a validated self administered questionnaire used to evaluate asthma control.ACT assesses the frequency of shortness of breath and general asthma symptoms, use of rescue medications, the effect of asthma on daily functioning
Measured: 12 months
Secondary outcomes (13)
Incidence of treatment emergent Adverse and Serious Adverse Events (Safety and Tolerability
Safety assessed by the incidence of treatment pathway emergent adverse event (AE's) and Serious Adverse Events (SAE's) at study completion. The number of adverse events and serious adverse events will be tabulated also by the number patients reporting an event.
Measured: 12 months
Patient Activation Measurement (PAM)
PAM is a tool used for measuring the level of patient engagement in their healthcare. It was designed to assess an individual's knowledge, skill and confidence for self-management. PAM is a 13-item scale that asks people about their beliefs, knowledge and confidence for engaging in a wide range of health behaviors and then assigns an activation score based on their responses to the 13-item scale. This will be assessed prior to and three months post intervention.
Measured: 12 months
Asthma Exacerbation
Asthma exacerbation data will be collecting from their primary prescriber on their exacerbation history. The numbers of asthma exacerbations requiring oral antibiotics and/or oral steroids by the participants one year prior to starting the study will be recorded at visit one. If the participant has any exacerbations requiring oral antibiotics and/or steroids during the study period this will be recorded during monthly telephone contact with participants and at visit 2 .
Measured: 12 months
Inhaler Technique
This will be assessed using the "7 Steps to successfully inhaler technique developed by the UK Inhaler Group. Each step is evaluated as being Good or Poor and the number of critical errors will be recorded.
Measured: 12 months
Health Care Usage
Change in the median number of hospital and primary care interventions in the 6 months prior to the study and during the study period from baseline to study completion
Measured: 12 months
Medication Adherence
Measure of primary and secondary medication adherence analysing prescription capture data, self-reported data via the MyAsthma app
Measured: 12 months
Lung Function
Mean change in FEV1 from baseline to study completion - FEV1 will be obtained using spirometry. Spirometry will be performed at screening and end of study visit
Measured: 12 months
Fractional Exhaled Nitric Oxide (FENO)
It is a simple breath test that measures the level of Nitric Oxide Concentration that the body naturally produces in the airways. FENo will be measured using a Bedfont device and will be performed at screening visit and end of study visit
Measured: 12 months
Health Economics Analysis
The measurement of health outcome used will be the Quality Adjusted Life Year (QALY) calculated using the EQ5D-5L questionnaire.The EQ5D 5L is a validated questionnaire which 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 patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine.The use of NHS resources from an adjusted baseline period prior to staring the study compared to during the study will be used as a comparator for cost outcomes
Measured: 12 months
Patient Health Questionnaire (PHQ9)
This is a self-administered validated questionnaire which scores each of the nine DSM-IV criteria as 0 (not at all) to 3 (nearly every day) and has been validated for use in primary care. It is not a screening tool for depression but it is used to monitor the severity of depression and response to treatment. Validity has been assessed against an independent structured mental health professional interview. PHQ-9 greater than or equal to 10 had a sensitivity of 88% and specificity of 88% for major depression. The questionnaire can be delivered over the telephone.
Measured: 12 month
General Anxiety Disorder (GAD7)
The GAD-7 is a self-administered validated questionnaire and is used as a screening tool and severity measure for generalised anxiety disorder The GAD-7 score is calculated by assigning scores of 0, 1, 2, and 3, to the response categories of 'not at all', 'several days', 'more than half the days', and 'nearly every day', respectively, and adding together the scores for the seven questions. Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively. When used as a screening tool, further evaluation is recommended when the score is 10 or greater. Using the threshold score of 10, the GAD-7 has a sensitivity of 89% and a specificity of 82% for GAD. It is moderately good at screening three other common anxiety disorders - panic disorder (sensitivity 74%, specificity 81%), social anxiety disorder (sensitivity 72%, specificity 80%) and post-traumatic stress disorder (sensitivity 66%, specificity 81%).
Measured: 12 months
Problematic Experiences of Therapy (PETS)
This is a validated questionnaire which measures difficulties experienced following the advice provided by an intervention.It has 4 domains which cover: 1) Whether symptoms themselves impede ability to follow advice, or are worsened by the advice, 2) Uncertainty about how to follow the advice, 3) Doubts about the efficacy of the app or online advice and 4) Practical obstacles to following the advice such as time or opportunity.
Measured: 12 months
Self Efficacy for Appropriate Medication use Scale (SEAMS)
Was developed by a multidisciplinary team with expertise in medication adherence and health literacy. Its psychometric properties were then evaluated among 436 patients with coronary heart disease among other comorbid conditions. Reliability was evaluated by measuring internal consistency and test-retest reliability. The final 13 item scale showed good internal consistency reliability (Cronbach's alpha= 0.89). The SEAMS is a reliable and valid instrument that may provide a valuable assessment of medication self-efficacy in chronic disease management and appears to also be appropriate for use in patients with low literacy.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2018
- Study start8 Mar 2019 (estimated)
- Primary completion31 Mar 2021 (estimated)
- Study completion31 Mar 2021 (estimated)
Why it stopped: Lack of Funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (32)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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Open Feasibility
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- my mhealth Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Expert Health Ltd, CLAHRC Wessex
- Responsible party
- Sponsor
- Investigators
- Minal Bakhai, Principal investigator, Lloyds Pharmacy Online Doctor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03511482
- Sponsor's protocol ID
- IDEAL 001
- Acronym
- IDEAL
- Status last verified
- Mar 2019
- First submitted
- 4 Apr 2018
- Last updated
- 14 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
de Jong CC, Ros WJ, Schrijvers G. The effects on health behavior and health outcomes of Internet-based asynchronous communication between health providers and patients with a chronic condition: a systematic review. J Med Internet Res. 2014 Jan 16;16(1):e19. doi: 10.2196/jmir.3000.
PubMed 24434570Morrison D, Wyke S, Saunderson K, McConnachie A, Agur K, Chaudhuri R, Thomas M, Thomson NC, Yardley L, Mair FS. Findings from a pilot Randomised trial of an Asthma Internet Self-management Intervention (RAISIN). BMJ Open. 2016 May 12;6(5):e009254. doi: 10.1136/bmjopen-2015-009254.
PubMed 27173807Nystuen P, Hagen KB. Telephone reminders are effective in recruiting nonresponding patients to randomized controlled trials. J Clin Epidemiol. 2004 Aug;57(8):773-6. doi: 10.1016/j.jclinepi.2003.12.015.
PubMed 15485728Harris TJ, Carey IM, Victor CR, Adams R, Cook DG. Optimising recruitment into a study of physical activity in older people: a randomised controlled trial of different approaches. Age Ageing. 2008 Nov;37(6):659-65. doi: 10.1093/ageing/afn159. Epub 2008 Aug 20.
PubMed 18718924Treweek S, Pitkethly M, Cook J, Fraser C, Mitchell E, Sullivan F, Jackson C, Taskila TK, Gardner H. Strategies to improve recruitment to randomised trials. Cochrane Database Syst Rev. 2018 Feb 22;2(2):MR000013. doi: 10.1002/14651858.MR000013.pub6.
PubMed 29468635Leathem CS, Cupples ME, Byrne MC, O'Malley M, Houlihan A, Murphy AW, Smith SM. Identifying strategies to maximise recruitment and retention of practices and patients in a multicentre randomised controlled trial of an intervention to optimise secondary prevention for coronary heart disease in primary care. BMC Med Res Methodol. 2009 Jun 19;9:40. doi: 10.1186/1471-2288-9-40.
PubMed 19545366Braganza G, Chaudhuri R, McSharry C, Weir CJ, Donnelly I, Jolly L, Lafferty J, Lloyd SM, Spears M, Mair F, Thomson NC. Effects of short-term treatment with atorvastatin in smokers with asthma--a randomized controlled trial. BMC Pulm Med. 2011 Apr 7;11:16. doi: 10.1186/1471-2466-11-16.
PubMed 21473764Wright GR, Howieson S, McSharry C, McMahon AD, Chaudhuri R, Thompson J, Donnelly I, Brooks RG, Lawson A, Jolly L, McAlpine L, King EM, Chapman MD, Wood S, Thomson NC. Effect of improved home ventilation on asthma control and house dust mite allergen levels. Allergy. 2009 Nov;64(11):1671-80. doi: 10.1111/j.1398-9995.2009.02098.x. Epub 2009 Jul 24.
PubMed 19650848Schatz 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.
PubMed 19767070Glaser, BG and Strauss, A. 1967. The discovery of grounded theory: Strategies for qualitative research, Chicago, IL: Aldine.
Pope C, Mays N (2006) Qualitative Research in Health Care (3rd Edition) London: BMJ Books.
Braun, V. and Clarke, V. (2006) Using thematic analysis in psychology. Qualitative Research in Psychology, 3 (2). pp. 77-101. ISSN 1478-0887 Available from: http://eprints.uwe.ac.uk/11735
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 19651589Guendelman S, Meade K, Benson M, Chen YQ, Samuels S. Improving asthma outcomes and self-management behaviors of inner-city children: a randomized trial of the Health Buddy interactive device and an asthma diary. Arch Pediatr Adolesc Med. 2002 Feb;156(2):114-20. doi: 10.1001/archpedi.156.2.114.
PubMed 11814370
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Feasibility Study to Investigate the Impact of A Digitally Delivered Asthma Service for Patients in Primary Care (IDEAL-001: Integrated Digitally EnhAnced Care for Long-term Conditions-001
- ClinicalTrials.gov ID
- NCT03511482
- Acronym / sponsor ID
- IDEAL / IDEAL 001
- Conditions
- Asthma
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of Funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- my mhealth LtdIndustry (pharma, biotech, devices)
- Collaborators
- Expert Health Ltd, CLAHRC Wessex
- Study start
- 8 Mar 2019 (estimated)
- Primary completion
- 31 Mar 2021 (estimated)
- Study completion
- 31 Mar 2021 (estimated)
- First posted
- 27 Apr 2018 (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 difficulties. There is currently no cure for asthma but the use of simple inhaler treatments can keep the symptoms under control. If asthma symptoms get worse this can lead to an asthma attack which can be life-threatening. It has been shown that most of the deaths related to asthma are preventable if asthma is managed using the correct treatment plan however a significant proportion of patients are not using the right inhalers or not using them properly and do not know how to manage their asthma if it gets worse.
There is currently an unmet need to develop tools that can help improve asthma care, identify high risk patients, closely monitor their asthma control in 'real time' and intervene to optimise treatment to prevent asthma attacks. Both patients and indeed, the current British Thoracic Society (BTS) asthma guidelines recognise that technology has the potential to be used to improve asthma care and could lead to reductions in National Health Service (NHS) services use and improvements in symptoms.
Patients with better controlled asthma are less likely to be admitted to hospital and more likely to have an improved quality of life. This study aims to evaluate the delivery of an asthma service using an online doctor providing remote consultations paired with a self-management asthma app. The patients will use the app to input and track their symptoms, which will be monitored by a doctor remotely who can provide advice, optimise medications and intervene in a timely manner to prevent an asthma attack. The service is interactive, so the patient and doctor can communicate with one another 7 days a week by completing a consultation or sending messages via the online doctor portal or speaking on the telephone. The app will relay information about environmental triggers to the patient to help prevent the patient's asthma getting worse. The service will provide a new and potentially more convenient way of delivering routine appointments to reduce the numbers that do not attend. The patients will be able to watch educational videos stored on the app about asthma to potentially improve understanding of their condition. Digital training in inhaler technique will be supported with face to face support from pharmacists.
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 (with solutions personalised to an individual's triggers) and equip healthcare professionals with the data to identify those people at higher risk of an attack.
This is a before-and-after open interventional study, which means participants' asthma control will be compared before and after using the digital asthma management service. It is not a randomised study and participants will be given the choice of using a digital service. It is a single-centre study which will take place within one Clinical Commissioning Group (CCG) in Hampshire (UK), across at least two GP surgeries. It is anticipated that approximately 80 patients will be recruited.
Patients will be provided with this digital asthma service for a period of 6 months of 2018 and outcomes will be measured using a combination of questionnaires (quality of life, patient satisfaction, level of activation) and quantitative measures such as Forced Expired Volume over 1 second (FEV1)(measure of airway obstruction), Fractional Exhaled Nitric Oxide (FENO) (measure of airway inflammation) and Asthma Control Test Scores (measure of symptom control). Feedback from NHS professionals hosting the study and online doctors will also be sought. A Health economic model will be generated comparing the digitally enhanced model versus usual care. The main outcome of this study is looking at whether this new model of service delivery can provide an improvement in asthma control test scores.
Detailed description
Asthma is a 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. 4.3 million adults (1 in 12) in the UK are currently receiving treatment for asthma. Treatment usually involves a combination of reliever and preventative inhaler therapy. On average 3 people a day die from asthma. The National Review of Asthma Deaths (NRAD) has shown that much of the morbidity relates to poor management particularly around the use of preventative treatment concluding that two-thirds of asthma deaths were preventable.
We have a well-established evidence base of how to help control asthma and prevent attacks using interventions that focus on maintaining control and reducing risk of an attack. However, there are concerns that the current National health Service (NHS) model of care: a once annual asthma review may not capture the full picture of asthma control 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 the best care and motivate good asthma self-management, but this can be complex and time-consuming and so often is not possible in the allotted time for primary care appointments, leading to adverse outcomes and to variation in care.
Opportunities to address this variation 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, ensuring safer prescribing to highlight where people with asthma have been prescribed excessive quantities of Short Acting Beta Agonist (SABA) inhalers, improving systems to arrange follow up, raising the quality of medical records and enabling systems to support asthma self-management.
The NHS spends around 1 billion a year treating and caring for people with asthma. Asthma accounts for about 60,000 hospital admissions per year. The annual 2016 asthma survey reported an overwhelming majority of patients, 82%, said their asthma was poorly controlled. Almost half of respondents said their asthma interfered with their day to day life and 46% said they had difficulty sleeping due to their asthma symptoms. Those with uncontrolled asthma were almost twice as likely to be admitted to hospital as those whose asthma symptoms were under control. The majority of patients admitted to hospital did not receive follow up putting them at higher risk of future attacks and re-admission to hospital. In the United Kingdom (UK) seven out of ten people with asthma receive care that fails to meet basic quality standards with 30-70% reported as not taking their asthma medication as prescribed.
With 85% of asthma patients being managed exclusively in primary care, asthma is estimated to account for around 2-3% of General Practitioners (GP) consultations19, costing an estimated £108 million annually. As highlighted by the recent General Practice Five Year Forward View, with an ever-increasing burden on services, conventional models of care are constantly being challenged and alternative, cost-effective ways of delivering healthcare to a larger cohort of patients are being sought.
Digital healthcare interventions may help to address some of these challenges by enabling remote delivery of patient-centred care, facilitating timely access to health advice and medications, prompting self-monitoring and medication compliance, and educating patients on trigger avoidance.
Telemonitoring, the transmission of monitoring data from a patient to an electronic health record which is shared with and monitored by healthcare professionals has the potential to improve outcomes. The impact of telemonitoring is likely to be strongly influenced by the level of professional support provided and personalisation of feedback. Studies have shown that people with poorly-controlled asthma have the potential to gain more by engaging with telemonitoring, helping people recognise worsening control and take preventative action to reduce their risk of an attack early. There is a substantial body of evidence to show that self-management education incorporating written personalised asthma action plans improves health outcomes for people with asthma. Self-management education reduces emergency use of healthcare resources including Accident and Emergency department visits and hospital admissions and improves markers of asthma control, including reduced symptoms and days off work and improved quality of life. Internet technology might offer an attractive means for encouraging patients to use self-management strategies within a day-to-day context.
In 2015, two thirds of patients with asthma had a smartphone, and with this ever-increasing presence of technology in homes, online prescribing and remote monitoring is beginning to emerge as an alternative way of delivering services. Nearly three-quarters of patients wanted to see an mHealth device that would help them monitor their asthma and nearly half would value a system which could be used as part of their asthma action plan and advise them if changes to medication have improved their asthma and when to seek medical attention. Three-quarters of healthcare professionals said they would value an mHealth system that would monitor patients' asthma symptoms over time and provide patients with an asthma action plan.
Systematic review has shown that despite the heterogenous interventions, technology enabled healthcare can improve process outcomes such as knowledge adherence to monitoring, 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 computerised decision support systems need to align better with professional workflows so that pertinent and timely advice is easily accessible within the consultation. Evidence to support asynchronous remote consulting suggests that it leads to reductions in healthcare usage and disease status although evidence is very limited and of low quality in this patient group.
Systematic review of 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 the studies in asthma patients gave results encouraging enough to suggest further analysis of digital models of care. To the best of our knowledge, this is the first study looking at an integrated approach of using a self-management app, telemonitoring and asynchronous remote consulting in asthma patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Open Feasibility
| Arm | Type | Receives |
|---|---|---|
| MyAsthma Application and Lloyds Pharmacy Online Doctor | Experimental | Device: Lloyds Pharmacy Online DoctorWeb based applications to support people with Asthma management |
| MyAsthma Application and Usual care | Experimental | Device: myAsthma ApplicationWeb based application to support people with Asthma Management |
| Usual care only (control) | No intervention | –Usual care of asthma management |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adult patients aged 18 years and over
- Able to give written informed consent
- A clinical diagnosis of Asthma on regular inhaled medication
- Measures of poor asthma control: Oral steroid use in the last 12 months and /or ACT score of less than 20 at screening, and/or use of 6 or more short acting beta-agonist inhalers in the last 6 months and/or frequent symptoms and/or (Accident and Emergency) A+E or hospital admission for asthma
- Access to the internet at home, use of mobile technology and the ability to operate a web platform in English
Key exclusion criteria (14 listed)
- Asthma exacerbation in the past 4-6 weeks (Baseline visit to be delayed)
- . Patients who have a significant medical comorbidity that can present with asthma type symptoms e.g. COPD, Heart Failure, Lung Cancer (these cases require physical examination and a remote assessment would not be appropriate)
- Terminal Illness Pregnant
- Breast Feeding
- Patients who have another medical condition, including but not limited to respiratory immunological or cardiac disease other than asthma deemed by the investigators as significant
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 |
|---|---|---|
| myAsthma ApplicationmyAsthma Application is a Multi facetted online self management tool developed by my mhealth Ltd, which is an online interface for patient to feedback symptoms and (Quality of Life) QoL score. The app consists of an online action /self management plan, Patient education videos, medication diary, Peak Flow diary, Inhaler technique videos, mindfulness videos as well as weather and Pollution forecasters. | Device | MyAsthma Application and Usual care |
| Lloyds Pharmacy Online DoctorOnline Doctor is part of Expert Health Ltd a doctor-led initiative providing safe and reliable remote online healthcare to adults in the UK. Their patient-centred model of healthcare allows patients to tailor care around their schedule and increases healthcare access for harder-to-reach patient groups. As the first ever online healthcare organisation to register with the government regulator of healthcare - and having received outstanding feedback from the Care Quality Commission about the high level of safe, effective, caring, responsive and well led care provided by the service - They pride themselves on their pioneer status and work constantly to expand the boundaries of personalised healthcare. | Device | MyAsthma Application and Lloyds Pharmacy Online Doctor |
Primary outcome
Asthma Control Test (ACT)
Time frame: 12 months
The ACT is a validated self administered questionnaire used to evaluate asthma control.ACT assesses the frequency of shortness of breath and general asthma symptoms, use of rescue medications, the effect of asthma on daily functioning
13 secondary outcomes
Incidence of treatment emergent Adverse and Serious Adverse Events (Safety and Tolerability
Time frame: 12 months
Patient Activation Measurement (PAM)
Time frame: 12 months
Asthma Exacerbation
Time frame: 12 months
Inhaler Technique
Time frame: 12 months
Health Care Usage
Time frame: 12 months
Medication Adherence
Time frame: 12 months
Lung Function
Time frame: 12 months
Fractional Exhaled Nitric Oxide (FENO)
Time frame: 12 months
Health Economics Analysis
Time frame: 12 months
Patient Health Questionnaire (PHQ9)
Time frame: 12 month
General Anxiety Disorder (GAD7)
Time frame: 12 months
Problematic Experiences of Therapy (PETS)
Time frame: 12 months
Self Efficacy for Appropriate Medication use Scale (SEAMS)
Time frame: 12 months
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 14 Aug 2019.
- Background: PubMed 24434570de Jong CC, Ros WJ, Schrijvers G. The effects on health behavior and health outcomes of Internet-based asynchronous communication between health providers and patients with a chronic condition: a systematic review. J Med Internet Res. 2014 Jan 16;16(1):e19. doi: 10.2196/jmir.3000.
- Background: PubMed 27173807Morrison D, Wyke S, Saunderson K, McConnachie A, Agur K, Chaudhuri R, Thomas M, Thomson NC, Yardley L, Mair FS. Findings from a pilot Randomised trial of an Asthma Internet Self-management Intervention (RAISIN). BMJ Open. 2016 May 12;6(5):e009254. doi: 10.1136/bmjopen-2015-009254.
- Background: PubMed 15485728Nystuen P, Hagen KB. Telephone reminders are effective in recruiting nonresponding patients to randomized controlled trials. J Clin Epidemiol. 2004 Aug;57(8):773-6. doi: 10.1016/j.jclinepi.2003.12.015.
- Background: PubMed 18718924Harris TJ, Carey IM, Victor CR, Adams R, Cook DG. Optimising recruitment into a study of physical activity in older people: a randomised controlled trial of different approaches. Age Ageing. 2008 Nov;37(6):659-65. doi: 10.1093/ageing/afn159. Epub 2008 Aug 20.
- Background: PubMed 29468635Treweek S, Pitkethly M, Cook J, Fraser C, Mitchell E, Sullivan F, Jackson C, Taskila TK, Gardner H. Strategies to improve recruitment to randomised trials. Cochrane Database Syst Rev. 2018 Feb 22;2(2):MR000013. doi: 10.1002/14651858.MR000013.pub6.
- Background: PubMed 19545366Leathem CS, Cupples ME, Byrne MC, O'Malley M, Houlihan A, Murphy AW, Smith SM. Identifying strategies to maximise recruitment and retention of practices and patients in a multicentre randomised controlled trial of an intervention to optimise secondary prevention for coronary heart disease in primary care. BMC Med Res Methodol. 2009 Jun 19;9:40. doi: 10.1186/1471-2288-9-40.
- Background: PubMed 21473764Braganza G, Chaudhuri R, McSharry C, Weir CJ, Donnelly I, Jolly L, Lafferty J, Lloyd SM, Spears M, Mair F, Thomson NC. Effects of short-term treatment with atorvastatin in smokers with asthma--a randomized controlled trial. BMC Pulm Med. 2011 Apr 7;11:16. doi: 10.1186/1471-2466-11-16.
- Background: PubMed 19650848Wright GR, Howieson S, McSharry C, McMahon AD, Chaudhuri R, Thompson J, Donnelly I, Brooks RG, Lawson A, Jolly L, McAlpine L, King EM, Chapman MD, Wood S, Thomson NC. Effect of improved home ventilation on asthma control and house dust mite allergen levels. Allergy. 2009 Nov;64(11):1671-80. doi: 10.1111/j.1398-9995.2009.02098.x. Epub 2009 Jul 24.
- Background: PubMed 19767070Schatz 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.
- BackgroundGlaser, BG and Strauss, A. 1967. The discovery of grounded theory: Strategies for qualitative research, Chicago, IL: Aldine.
- BackgroundPope C, Mays N (2006) Qualitative Research in Health Care (3rd Edition) London: BMJ Books.
- BackgroundBraun, V. and Clarke, V. (2006) Using thematic analysis in psychology. Qualitative Research in Psychology, 3 (2). pp. 77-101. ISSN 1478-0887 Available from: http://eprints.uwe.ac.uk/11735
- British Thoracic Society / Scottish Intercollegiate Guidelines Network (BTS/SIGN) Asthma Management Guidelines 2016Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Minal Bakhai principal investigator
Lloyds Pharmacy Online Doctor
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 Application and Lloyds Pharmacy Online Doctor 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 7 inclusion and 14 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 14 Aug 2019. 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?
Asthma Control Test (ACT) (time frame: 12 months). 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 NCT03511482, which also lists 32 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 14 Aug 2019.