Can outcomes for children with asthma be improved by enhancing integrated care with technology?
| ISRCTN | ISRCTN61239845 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN61239845 |
| IRAS number | 311701 |
| Secondary identifying numbers | CPMS 54727, IRAS 311701 |
- Submission date
- 17/03/2023
- Registration date
- 28/03/2023
- Last edited
- 05/06/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Respiratory
Plain English Summary
Background and study aims
Asthma is the most common long-term condition among children, yet outcomes are often poor. The National Review of Asthma Deaths (NRAD) found deficits in care: 93% of children had received inadequate routine care. 4% of children were thought to have received a good standard of care. In 48% of deaths reviewed, there was room for improvement in clinical care and/or organisation of care; while in 46% of cases, care was well below expected standards. Health for children with asthma could be improved with care pathways that improve prevention, self-management, risk stratification, treatment, and monitoring. Effective technology could augment an integrated care pathway to provide a comprehensive package of care. To achieve good outcomes for asthma, the priority is to prevent attacks with inhaled corticosteroids (ICS) and to recognise and manage wheeze promptly and effectively. However, traditional asthma care is associated with unmet needs along each step of the pathway including poor adherence to ICS - as low as 30% in some populations, adverse outcomes, and poor outcomes at a national level. This project aims to improve outcomes among children with asthma by enhancing newly developed integrated care pathways with technology for improving symptom and treatment tracking. If successful, the combined technology-enhanced multidisciplinary integrated care pathway has the potential to transform outcomes for children with asthma.
Who can participate?
Children aged between ≥6 to <16 years who are registered with a GP in South London/North London and have an asthma Control Test score <20 and/or unscheduled healthcare use for asthma (primary or secondary care) within the last 6 months
What does the study involve?
Patients that are eligible for the trial will be randomised into one of two groups and will remain in the trial for 6months unless they withdraw (there will be a 12-months follow-up for children already recruited) Participants randomised to group 1 will be given two devices - a SMART sensor (inhaler top sensors for preventer inhalers which enables remote monitoring of medication use, adherence, control, symptoms and triggers) and a Wheezo device which detects the presence of wheeze. Participants randomised to group 2 will continue with standard asthma care. The research team (via Health Touch) will ask all participants and parents/carers to complete various questions online at baseline, monthly and at 6-months follow-up (there will be a 12-month follow-up for children already recruited). Data will also be collected from health records. All data will be collected via a portal called Health Touch.
What are the possible benefits and risks of participating?
The research participants may experience direct benefits in terms of their asthma control by taking part in this research study. Participants in the control group will also provide a valuable contribution to the study, and if demonstrated to be effective, they may benefit from using these devices at a later date. This project has been checked by several people to minimise any potential risks. We do not anticipate any disadvantages to taking part in this study. The intervention devices (Wheezo and SMART/Propeller) are designed to improve asthma outcomes.
Where is the study run from?
This is a multicentre trial to be conducted predominantly in three London Boroughs (Lambeth, Southwark, and Tower Hamlets), through two Universities (KCL and QMUL) and associated NHS Trusts (Evelina London Children’s Hospital/GSTT and Barts Health Trust).
When is the study starting and how long is it expected to run for?
November 2021 to November 2025
Who is funding the study?
National Institute for Health and Care Research (NIHR) (UK)
Who is the main contact?
Professor Ingrid Wolfe, OBE, BSc, MBBS, MSc, PhD, FRCPCH, FFPH
Professor of Paediatrics and Child Health
Consultant in Paediatric Population Medicine
ingrid.wolfe@kcl.ac.uk (UK)
Contact information
Principal Investigator
Director, Institute of Women and Children's Health
Consultant in Paediatric Population Medicine
Reader in Paediatrics and Child Health
King's College London
5th Floor, Becket House
1 Lambeth Palace Road
London
SE1 7EU
United Kingdom
 ORCID ID |
0000-0002-4717-7634 |
|---|---|
| Phone | +44 (0)207 848 6668 |
| ingrid.wolfe@kcl.ac.uk |
Study information
| Study design | Randomized interventional study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice, Home, Hospital, Internet/virtual, Medical and other records |
| Study type | Prevention |
| Participant information sheet | 43367_PIS_6-11 years_V2.0_19Jan2023.pdf |
| Scientific title | Technology Enhanced integrated AsthMa care (TEAMCare): randomised control trial of technology to improve outcomes among children with asthma |
| Study acronym | TEAMCare |
| Study hypothesis | H0 - Combining technology with standard integrated asthma care will show no benefits in improving outcomes for children with asthma. H1 - Combining technology with standard integrated asthma care will help improve asthma outcomes for children. |
| Ethics approval(s) | Approved 02/02/2023, West of Scotland REC 1 (West of Scotland Research Ethics Service, Ward 11, Dykebar Hospital, Grahamston Road, Paisley, PA2 7DE, Scotland; +44 (0)141 314 0212; WosRec1@ggc.scot.nhs.uk), ref: 22/WS/0178 |
| Condition | Childhood asthma |
| Intervention | Current interventions as of 05/06/2025: 1. Intervention (Device Arm): technologically enhanced normal care pathways: Remote wheeze monitoring, using Wheezo AND remote treatment monitoring, using Propeller/Smart Respiratory (note: Propeller was discontinued from the UK market and was only used by participants randomised before 12/2024) 2. Control arm: normal care pathway Location This is a multicentre trial to be conducted predominantly in three London Boroughs (Lambeth, Southwark, and Tower Hamlets), through two Universities (KCL and QMUL) and associated NHS Trusts (Evelina London Children’s Hospital/GSTT and Barts Health Trust), as part of services integrated between secondary and primary care. Further participant identification centre (PIC) sites will also be included. Participant Recruitment and Randomisation Children and young people (aged ≥ 6 to < 16 years) with poorly controlled asthma will be identified through several routes: 1) Eligible patients receiving or referred for integrated care will be invited to participate in the study. 2) Eligible patients identified in a TEAMCare specific Call-recall schedules (proactive identification via primary care records) will be directed to the research portal and invited to participate in the study. 3) Children who attend an Emergency Department or are admitted for non-elective care for asthma, and children attending outpatient clinics for asthma will be invited, with their parent/carer, to participate in the study. In addition to direct referrals from Emergency Department staff, Specialist asthma nurses based at Guy’s and St Thomas’s or Bart Health NHS Trusts will check the list of Emergency Department attendances on a weekly basis. 4) Eligible children identified at affiliated Participant Identification Centres (PIC) sites will be invited to take part in the study All eligible children interested in the study will be sent a Participant Information Sheet. Participant information sheets will be translated as appropriate for the target populations. Those who would like to participate will be asked to give informed consent to participate in the evaluation and follow-up, for 1) access to health care records, 2) completing questionnaires at baseline and follow-up time points, and 3) participating in specific elements of nested studies, e.g. qualitative interviews and app and device data sharing. For children under 12 years of age the parent/carer will be asked to provide, on behalf of the child, informed consent. For adolescents between 12 and < 16 years of age, the parent will be asked to provide informed consent and the young person will be asked to provide assent to participate. Stratification: Randomisation will be stratified to ensure balance across the trial arms at each site. Recruitment plan assessment We have reviewed the prevalence of children with asthma in our study site populations, and our current methods for reaching them. Across Southwark and Lambeth, we expect to identify ~10,500 children with asthma (using call-recall via primary care records); of these, ~1400 children would be expected to take up the service, based on previous experience. Across Tower Hamlets children will be invited through their integrated Asthma Service. However, the current integrated asthma services do not have sufficient capacity to provide care for the large numbers of eligible children we would expect to recruit through proactive identification of unmet needs. We therefore will need to employ additional recruitment methods, described below. 4.5.2 Recruitment via TEAMCare specific call-recall schedules. For the integrated service in Southwark and Lambeth, children are proactively identified, using primary care records. This process is carried out within General Practitioner (GP) practices or Federations using a CYPHP developed ‘call-recall’ tool, adapting a well-established public health system for contacting patients for vaccination and screening. We will adapt the integrated service’s system for identifying children with asthma to target only those children within the TEAMCare trial age range. Children with asthma will be invited via text message to be part of the study and will be directed, via an embedded link, to the trials research portal rather than the current route which is via the integrated service portal. An ACT test or self-reported unscheduled care use will determine the child’s eligibility. Participant enrolment and follow-up Following consent and randomisation, participants will be given a supported introduction to the technology (if applicable), including registration and onboarding to use the associated mobile Apps and web portals. They will be asked to continue the use of the device and associated mobile App at home for 6 months. Additionally, all participants, regardless of group, will be asked to complete follow-up questionnaires administered online at baseline, monthly and at 6-months follow-up (there will be a 12-months follow-up for children already recruited). A sub-group of participants will be invited to participate in the nested qualitative research. Discussions throughout the trial will take place with commissioning bodies to ensure trial results provide appropriate information for commissioning purposes with a view to the continuation of the rollout of these technologies should their use prove beneficial. Analysis methods While participants and practitioners will be unblinded, data analysts will be blinded. The main planned comparisons is: • Device arm vs. Control arm Data and Information Governance Data collection: With participant consent and data sharing agreements in place, data will be extracted from participant health care records during the follow-up period. Participants will be invited to complete questionnaires at baseline, monthly and at 6-months follow-up (there will be a 12-months follow-up for children already recruited), to assess the outcomes described above and a short monthly survey to give details of any unscheduled healthcare attendance. Data handling: Data will be held securely in a trials database, in line with the sponsor’s requirements, accessed through password protected computers. Study data will be anonymised with a unique study identification code. Participant identifiable data will be accessed only when necessary for study administration (e.g. monitoring, follow-up). Anonymised data sets will be used by the research team for analysis. Previous Interventions: Briefly, the intervention involves technologically enhanced integrated care pathways in the following groups: 1. Remote wheeze monitoring, using Wheezo, within the integrated care pathway 2. Remote treatment monitoring, using Propeller, within the integrated care pathway 3. Control: integrated care pathway Location This is a multicentre trial to be conducted in three London Boroughs (Lambeth, Southwark, and Tower Hamlets), through two Universities (KCL and QMUL) and associated NHS Trusts (Evelina London Children’s Hospital/GSTT and Barts and The London), as services integrated between secondary and primary care. There are no site-specific requirements beyond the integrated care services that already exist or are in development. Participant population The trial will be conducted as part of the usual integrated care services for children with asthma. Patients with asthma are identified proactively as part of integrated care using population health management tools and methods for identification. These include primary care patient lists, secondary care patient lists, and schools. The trial will be conducted alongside the usual pathway of care which is integrated between primary and secondary care. Participant Recruitment and Randomisation Trial participants will be identified through two routes: 1. All eligible patients receiving or referred for integrated care will be invited to participate in the study and provided with information in formats for parent and child, to consider. Participant information sheets will be professionally translated as appropriate for the target populations 2. Children who attend an Emergency Department or are admitted for non-elective care for asthma, and children attending outpatient clinics will be invited, with their parent/carer, to participate in the study. In addition to direct referrals from Emergency Department staff, TEAMCare research nurses will check the list of Emergency Department attendances on a weekly basis. Those who would like to participate after reading the patient information sheet will be asked to give informed consent to participate in the evaluation and follow-up, for a) access to health care records, b) completing questionnaires at baseline and follow-up time points, and c) participating in specific elements of nested studies, e.g. qualitative interviews and app and device data sharing. For children under 12 years of age, the parent/carer will be asked to provide, on behalf of the child, informed consent. For adolescents between 12 and 16 years of age, the parent will be asked to provide informed consent and the young person will be asked to provide assent to participate. Professional translators will be used as appropriate. Stratification: Randomisation will be stratified to ensure balance across the trial arms at each site. Recruitment plan assessment We have reviewed the prevalence of children with asthma in our study site populations, and our current methods for reaching them. Across our two sites, we expect to invite ~10,500 children for an online asthma (biopsychosocial) health check during a six-month recruitment period, and ~1400 children to take up the service and be invited to participate in the study through this route. Therefore, over a 12-month period, and in combination with the other recruitment methods, (e.g. attendance at emergency departments) we are confident about recruiting our required sample. Participant enrolment and follow-up Following consent and randomisation to the three trial arms, participants in the two interventional study arms will be given a technology induction including a demonstration of the device and registration for the mobile App and web portal. They will be asked to continue the use of the device and associated mobile App at home for the following 12 months. Additionally, all participants, regardless of group, will be asked to complete follow-up questionnaires administered online at baseline, 6 and 12 months after enrolment as well as a short monthly questionnaire about unscheduled healthcare use. A sub-group of participants will be invited to participate in the nested qualitative research. Discussions throughout the trial will take place with commissioning bodies to ensure trial results provide appropriate information for commissioning purposes with a view to the continuation of the rollout of these technologies should their use prove beneficial. Analysis methods While participants and practitioners will be unblinded, data analysts will be blinded. The main planned comparisons are: 1. Wheezo trial arm versus Control 2) Propeller trial arm versus Control Regression analyses will be used to estimate the effect size of intervention in each arm, compared with the control, with appropriate covariates including the trial site. Data and Information Governance Data collection: With participant consent and data sharing agreements in place, data will be extracted from participant health care records during the follow-up period. Participants will be invited to complete questionnaires at baseline, 6- months, and 12-month follow-up, to assess the secondary outcomes described above and a short monthly survey to give details of any unscheduled healthcare attendance. Data handling: Data will be held securely in a trials database, in line with the sponsor’s requirements, accessed through password-protected computers. Study data will be anonymised with a unique study identification code. Participant-identifiable data will be accessed only when necessary for study administration (e.g. monitoring, and follow-up). Anonymised data sets will be used by the research team for analysis |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Wheezo, Propeller to Wheezo, SMART Respiratory |
| Primary outcome measure | Current primary outcome measure as of 05/06/2025: Asthma symptom control measured using the asthma control test (ACT) scores among participants at baseline, 6 months, and 12* months. * only for children recruited before 12/24 Previous primary outcome measure: The proportion of participants requiring unscheduled health service use for asthma during the 12-month intervention period measured using parent/patient reporting in a monthly online questionnaire and by extracting data from primary and secondary care health records, where possible |
| Secondary outcome measures | Current secondary outcome measure as of 05/06/2025: 1. Rates of primary and secondary care health service use, and medicines use during the follow-up period, measured by extracting data from primary and secondary care health records during the 6 and 12*-month intervention period and via patient/parent reporting where appropriate 2. Health-related quality of life, measured using the Pediatric Quality of Life Inventory (PedsQL) at baseline, 6 and 12* months 3. Missed days of school and parental missed days of work, measured using the TEAMCare Healthcare Service Use Information Questionnaire (non-validated) completed monthly during the 6 and 12*-month intervention period 4. User experience of the Wheezo and Propeller technologies, measured by data extracted from qualitative interviews * Only applicable for patients who were randomised before 12/2024 Previous secondary outcome measure: 1. Rates of primary and secondary care health service use, and medicines use during the follow-up period, measured by extracting data from primary and secondary care health records during the 12-month intervention period and via patient/parent reporting where appropriate 2. Children’s health-related quality of life, measured using the Pediatric Quality of Life Inventory (PedsQL) and the Child Health Utility 9 Dimension (CHU-9D) at baseline, 6 months, and 12 months 3. Children’s asthma symptoms, measured using the Asthma Control Test (ACT) at baseline, 6 months, and 12 months 4. Parental wellbeing, measured using the Warwick Edinburgh Mental Wellbeing Score (WEMWS) at baseline,6 and 12 months 5. Children’s wellbeing and mental health, measured using the Strengths and Difficulties Questionnaire (SDQ) at baseline, 6 months, and 12 months 6. Missed days of school and parental missed days of work, measured using the TEAMCare Healthcare Service Use Information Questionnaire (non validated) completed monthly during the 12-month intervention period 7. User experience of the Wheezo and Propeller technologies, measured by data extracted from qualitative interviews |
| Overall study start date | 01/11/2021 |
| Overall study end date | 30/11/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 6 Years |
| Upper age limit | 16 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 1455; UK Sample Size: 1455 |
| Participant inclusion criteria | Current participant inclusion criteria as of 05/06/2025: 1. Asthma Control Test score <20 within the last 6 months and/or unscheduled healthcare use for asthma (primary or secondary care) within the last 6 months 2. Age between ≥ 6 and < 16 years at enrolment 3. Able to provide informed consent/assent 4. A good command of English in order to use the device apps 5. Access to a smartphone 6. Access to an email address 7. Use of or ability to change to an inhaler compatible with Smart Respiratory smart sensors Previous participant inclusion criteria: 1. Asthma Control Test score < 20 and/or unscheduled healthcare use for asthma (primary or secondary care) within the last 6 months 2. Age between 6 and 16 years at enrolment 3. Able to provide informed consent/assent 4. Access to a smartphone 5. Access to an email address 6. Use of or ability to change to an inhaler compatible with Propeller smart sensors |
| Participant exclusion criteria | Current participant exclusion criteria as of 05/06/2025: 1. Participation in other asthma studies with a direct bearing on treatment 2. Patients who have 'opted out of the national data opt-out NHS service' Previous participant exclusion criteria: Participation in other asthma studies with a direct bearing on treatment |
| Recruitment start date | 01/04/2023 |
| Recruitment end date | 31/05/2025 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
London
SE1 7EH
United Kingdom
London
E1 2ES
United Kingdom
Sponsor information
University/education
C/o: Reza Razavi
Room 5.31
James Clerk Maxwell Building
57 Waterloo Road
London
SE1 8WA
England
United Kingdom
| Phone | +44 (0)207 8483224 |
|---|---|
| reza.razavi@kcl.ac.uk | |
| Website | http://www.kcl.ac.uk/index.aspx |
"ROR" |
https://ror.org/0220mzb33 |
Hospital/treatment centre
C/o: Rachel Fay
R&D Department
16th Floow Tower Wing
Great Maze Pond
London
SE1 9RT
England
United Kingdom
| Phone | +44 (0)207 1887188 |
|---|---|
| R&D@gstt.nhs.uk | |
| Website | http://www.guysandstthomas.nhs.uk/Home.aspx |
|
"ROR" |
https://ror.org/00j161312 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/03/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | The team anticipate that there will be different target audiences for our dissemination activities: 1. Professionals: findings will be disseminated to healthcare professionals via papers in high-impact peer-reviewed journals and present at local, national and international scientific meetings/conferences. 2. Service planners and commissioners: if the study is effective, we anticipate that our findings will have relevance for the provision of children with asthma, and therefore will be disseminated to those who plan and commission care for children with asthma. This includes NICE and SIGN 3. Voluntary sector: the findings will be made available to asthma charities. The team will offer summaries of the findings to websites for the public which already provide information on asthma and to charities offering information on asthma. |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 2.0 | 19/01/2023 | 27/03/2023 | No | Yes |
| Participant information sheet | version 2.0 | 19/01/2023 | 27/03/2023 | No | Yes |
| Participant information sheet | version 2.0 | 19/01/2023 | 27/03/2023 | No | Yes |
| HRA research summary | 28/06/2023 | No | No |
Additional files
Editorial Notes
05/06/2025: The following changes were made:
1. The overall study end date was changed from 31/03/2025 to 30/11/2025.
2. The interventions were updated.
3. The device names were updated from Wheezo, Propeller to Wheezo, SMART Respiratory.
4. The primary and secondary outcome measures were updated.
5. The participant inclusion and exclusion criteria were updated.
6. The recruitment end date was changed from 31/10/2024 to 31/05/2025.
7. The plain English summary was updated to reflect the above changes.
03/06/2024: The recruitment end date was changed from 31/03/2024 to 31/10/2024.
17/03/2023: Trial's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).
