Asthma Intermittent, UncontrolledADHOCNCT06849245
Εffectiveness of a Digital Social Intervention in Primary Care
A study testing A digital social intervention by primary care clinicians in people with Asthma Intermittent, Uncontrolled, run by Queen Mary University of London at 5 sites in United Kingdom.
Trial summary
The goal of this study is to deliver a definitive randomised controlled trial to measure the effectiveness and assess cost-effectiveness of a digital social intervention for patients with asthma, composed of promoting engagement with online peer support in a primary care consultation, followed by engagement with… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Asthma Intermittent, Uncontrolled
- What is being tested?
- A digital social intervention by primary care clinicians
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 5 sitesUnited Kingdom
- Study dates
- 25 Feb 2025to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- To participate in the study, participants will need to:
- Be adult asthma patients (aged 18 to 99) who have expressed their interest in digital social interventions in the recruitment survey.
- Report troublesome asthma (i.e. an ACT score of less than 20) in the recruitment survey).
- Be competent to consent for themselves, as determined by the healthcare professional delivering the consultation.
- There are no specific criteria for selecting participants for the exit interviews (a convenience sample of patients and clinicians will be used and recruitment will continue until data saturation).
Who cannot join
- Patients who are already members of the Asthma + Lung UK online health community or other asthma online health communities/Facebook groups (i.e. general use of social media will not prevent participation).
- Palliative or end of life patients.
- Patients receiving institutional long-term care (receiving total care in residential homes or living in nursing homes).
- Patients considered unsuitable to take part in the study by their general practitioners/nurses.
- There are no specific criteria for selecting participants for the exit interviews (a convenience sample of patients and clinicians will be used and recruitment will continue until data saturation).
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Georgios Karampatakis, PhD contact
5 sites in 1 country
United Kingdom5 sites, 5 recruiting
- Not yet recruiting
South West Peninsula Regional Research Delivery Network
Exeter
- Recruiting
East Midlands Regional Research Delivery Network
Leicester
- Recruiting
North London Regional Research Delivery Network
London
- Recruiting
North East and North Cumbria
Newcastle upon Tyne
- Recruiting
East of England Regional Research Delivery Network
Norwich
About this study
Official title: Measuring Whether Promotion of a Digital Social Intervention by Primary Care Healthcare Professionals and Subsequent Engagement With Online Peer Support Improves Health and Well-being of Patients With Asthma and is Cost-effective: a Randomised Controlled Trial
The goal of this study is to deliver a definitive randomised controlled trial to measure the effectiveness and assess cost-effectiveness of a digital social intervention for patients with asthma, composed of promoting engagement with online peer support in a primary care consultation, followed by engagement with online peer support for 12 months. The main questions/objectives this study aims to answer/address are:
- Does promoting engagement with an online health community in primary care help people with troublesome asthma to experience fewer asthma symptoms?
- To assess cost-effectiveness of the intervention (including quality of life, well-being, use of healthcare services etc); stakeholder satisfaction (patients and healthcare professionals) with the intervention; fidelity of protocol delivery; context in which positive outcomes can be triggered.
Read the detailed description
Patients with troublesome asthma, from 50-70 UK general practices, who might consider seeking advice online will be identified through a short online survey. The survey will include an asthma control test (ACT) questionnaire, a question about the network of support they have with their asthma, whether they are members of another existing online health community and whether they would be interested in taking part in a research study involving engagement in an asthma online health community (if randomised to the intervention arm).
Patients meeting the eligibility criteria will be asked to attend a one-to-one consultation with a healthcare professional at their general practice, who will randomise them using a randomisation tool and subsequently deliver the intervention encouraging them to engage with the asthma online health community or provide usual primary care, respectively. Participants of the intervention arm will be given a username and password for the Asthma + Lung UK online health community and shown how to login to the online health community. Participants will be asked to complete an online questionnaire at this consultation and again 12 months later. The consultation should take 30-45 minutes and completing the data-collection questionnaire 12 months later should take around 10 minutes.
During the 12-month period after the consultation, patients will be phoned by members of the research team every 3 months to collect data through an ACT questionnaire as well as volume of asthma exacerbations and associated healthcare utiilisation (primary and secondary care attendances) within last 3 months. Monthly text messages will also be sent to participants in the intervention arm who have consented, reminding them to engage with the online health community. The final follow-up questionnaire will include questions about how well their asthma is controlled, anxiety and depression, taking their asthma medication, and quality of life. Subject to participants' consent, the investigators will also endeavour to extract data from healthcare records about asthma exacerbations and use of primary and secondary care health services during the 12-month follow-up period (for both control and intervention arm participants). This data will be obtained from 'Discovery' for practices in North-East London. 'Discovery' is a clinical partnership project in East London, run by the Clinical Effectiveness Group at Queen Mary University of London and setting out to link primary and secondary care records, by creating a single database. The Clinical Effectiveness Group extracts data in an anonymised format. For practices in other parts of the UK, NHS Digital will be used to obtain data from healthcare records, and respective protocols and policies will be followed.
Data on intervention arm participants' use of the Asthma + Lung UK OHC during the study period will be collected and analysed, subject to consent, including the amount of engagement (number of days, hours/day etc.), community/ies joined, number of logins, number of likes, and time spent on pages, as well as the content of any public posts made by participants (private messages sent on the OHC will not be accessed or analysed).
At the end of the 12-month follow-up period, one-to-one interviews will be carried out with approximately 25 of the participating patients and approximately 15 of the HCPs involved in the study. Exact numbers will be determined by the point of data saturation being reached, with further interviewees being recruited if necessary. A convenience sample of participants will be invited (by email/text/phone) to take part in this one-off interview, which will last around one hour. Interviews will be carried out by a member of the research team and take place remotely via an appropriate online platform (Zoom or Microsoft Teams). During the interview, participants will be asked a series of questions (from a pre-determined list) exploring their views about their involvement in the study. Interviews will be audio recorded (after securing participants' consent - relevant field in the consent form) for subsequent analysis.
- Conditions
- Asthma Intermittent, Uncontrolled
- Being tested
- A digital social intervention by primary care clinicians
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A digital social intervention by primary care cliniciansBehavioural
- Signposting to the online health community by explaining different sections of the website.
- Introducing norms and values for passive (just reading) and active (writing posts) participation.
- Motivation for engagement with the online health community, emphasising that it could be used ad hoc (e.g. when feeling unwell, or when they need information or emotional support).
- Problem solving with respect to any difficulties/concerns.
- Signing patients up to the online health community, by explaining terms and conditions.
- Explaining the differences between posting publicly and privately (public posts are shared with third parties whereas private messages to other users are not shared).
- Collection of baseline measures. Data will be entered into the study's online database.
Patients will leave the consultation with a leaflet summarising all procedural matters in relation to signing up with the online health community and a reminder of their username and password.
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm in the ADHOC Trial (about 300 patients randomised to the intervention arm) | Experimental | A general practice-based healthcare professional will carry out the consultation and randomise participants to either the intervention or control group. Healthcare professionals will open a separate REDCap database to obtain the (automatically-generated) group assignment for the patient - either intervention or control - and will deliver the rest of the consultation accordingly. The intervention will consist of a one-off, face-to-face consultation with a practice-based clinician, followed by engagement with the Asthma + Lung UK online health community. The intervention will be delivered at the general practice with which each participant is registered. Receives: Behavioral: A digital social intervention by primary care clinicians |
| Control arm (about 300 patients randomised to the control arm) | No intervention | Control group patients will receive usual care alone, without any reference to online health communities and online peer support. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Control of asthma
Control of asthma will be self-reported by patients through an Asthma Control Test (ACT) questionnaire; minimum value: 5, maximum value: 25; higher scores indicate better asthma control.
Measured: Baseline and very three months in a 12 month follow-up period
Secondary outcomes (21)
Anxiety
Anxiety will be self-reported by patients through a GAD-7 (Generalised Anxiety Disorder 7-item instrument) questionnaire; minimum value: 0, maximum value: 21; higher scores indicate higher levels of anxiety.
Measured: Baseline and at the end of a 12 month follow-up period
Depression
Depression will be self-reported by patients through a PHQ-8 (8-item Patient Health Questionnaire depression scale) questionnaire; minimum value: 0, maximum value: 24; higher scores indicate higher levels of depression.
Measured: Baseline and at the end of a 12 month follow-up period
Self-efficacy
Self-efficacy will be self-reported by patients through the General Self-Efficacy Scale; minimum value: 10, maximum value: 40; higher scores indicate more self-efficacy.
Measured: Baseline and at the end of a 12 month follow-up period
Health-related quality of life
Health-related quality of life will be self-reported by patients through an EQ-5D-5L (European Quality of Life 5 Dimensions 5 Level Version) questionnaire; minimum value: -0.59, maximum value: 1; higher scores indicate better quality of life.
Measured: Baseline and very three months in a 12 month follow-up period
Adherence to medications
Adherence to medications will be self-reported by patients through a MARS-10 (10-item Medication Adherence Rating Scale) questionnaire; munimum value: 0, maximum value: 10; higher scores indicate better medication adherence.
Measured: Baseline and at the end of a 12 month follow-up period
Number of asthma exacerbations over last 3 months
Asthma exacerbations will be self-reported by patients through bespoke questions
Measured: Baseline and very three months in a 12 month follow-up period
Primary and secondary care use over last 3 months
Care use will be self-reported by patients through bespoke questions
Measured: Baseline and very three months in a 12 month follow-up period
Cost-effectiveness in relation to use of online health communities (likely a Markov model), including resource requirements, and costs for development, moderation, governance, and clinical oversight of online health communities
Within-trial and long-term cost-effectiveness analyses of online health communities' enhanced management versus current standard of asthma management in UK primary care. Costs of online health communities, healthcare and other resource use will be evaluated using nationally-representative unit costs of primary and secondary healthcare services. The within-trial cost-effectiveness will be assessed as incremental cost per quality-adjusted life year gained. The long-term cost-effectiveness of the OHCs will be evaluated using a long-term asthma model. Results will be presented as incremental cost effectiveness ratios.
Measured: Calculations/estimations at various time-points during a 12 month follow-up period
Amount of online health community engagement (for intervention arm participants)
Amount of engagement with the online health community will be self-reported by patients through a bespoke question
Measured: End of a 12 month follow-up period
Type (passive versus active) of online health community engagement (for intervention arm participants)
Type of engagement with the online health community will be self-reported by patients through a bespoke question
Measured: End of a 12 month follow-up period
Amount of time spent on the online health community (for intervention arm participants)
Amount of time spent on the online health community will be provided to the research team by the manager of the Asthma + Lung UK online health community
Measured: End of a 12 month follow-up period
Number of communities joined (for intervention arm participants)
Number of communities joined will be provided to the research team by the manager of the Asthma + Lung UK online health community
Measured: End of a 12 month follow-up period
Number of logins to the online health community (for intervention arm participants)
Number of logins will be provided to the research team by the manager of the Asthma + Lung UK online health community
Measured: End of a 12 month follow-up period
Number of likes on pages/posts within the online health community platform (for intervention arm participants)
Number of likes will be provided to the research team by the manager of the Asthma + Lung UK online health community
Measured: End of a 12 month follow-up period
Time spent on pages within the online health community (for intervention arm participants)
Time spent on pages will be provided to the research team by the manager of the Asthma + Lung UK online health community
Measured: End of a 12 month follow-up period
Public posts of the participants of the intervention arm within the online health community
Public posts will be provided to the research team by the manager of the Asthma + Lung UK online health community
Measured: End of a 12 month follow-up period
Time of each public post in the online health community by the intervention arm participants
Time of posts will be provided to the research team by the manager of the Asthma + Lung UK online health community
Measured: End of a 12 month follow-up period
Discussion thread of each public post in the online health community by the intervention arm participants
Discussion threads of each post will be provided to the research team by the manager of the Asthma + Lung UK online health community
Measured: End of a 12 month follow-up period
User details in each discussion thread in the online health community in which one of the intervention arm participants was involved
User details in each discussion thread will be provided to the research team by the manager of the Asthma + Lung UK online health community
Measured: End of a 12 month follow-up period
Experience of patients participating in the study
Experiences of patients will be obtained via qualitative interviews with patients
Measured: End of a 12 month follow-up period
Experience of clinicians carrying out the study-related consultations
Experiences of clinicians will be obtained via qualitative interviews with clinicians
Measured: End of a 12 month follow-up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2025
- Study start25 Feb 2025
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Asthma Intermittent, UncontrolledStudies of the same condition, open and under way.
- More trials run by Queen Mary University of LondonThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A general practice-based healthcare professional will carry out the study-related consultation (see 'Arms and Interventions' section below) and randomise participants to either the intervention or control group. Healthcare professionals will open a separate REDCap database to obtain the (automatically-generated) group assignment for the patient - either intervention or control - and will deliver the rest of the consultation accordingly.
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Queen Mary University of London
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom, City, University of London, University of Cambridge, University of Edinburgh, University of Nottingham, University of Surrey, St George's, University of London, Asthma UK
- Responsible party
- Sponsor
- Investigators
- Anna De Simoni, PhD, Principal investigator, Clinical Reader in Primary Care Research, Queen Mary University of London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06849245
- Sponsor's protocol ID
- 349517
- Acronym
- ADHOC
- Status last verified
- Nov 2025
- First submitted
- 27 Jan 2025
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data from individual participants will not be shared. Participants will not be individually identifiable from any research outputs. 'Pseudonymisation of data' will be the policy for ensuring confidentiality. All participants will be coded, by allocating them unique participation codes. The association between participation codes and names will be contained on a Word/Excel document and will be stored on a password-protected computer at Queen Mary University of London. Any electronic documents or hard copies of data collected from participants will only be accessible to the research team. Only members of the research team will have access to associations between names and participation codes. Every attempt will be made to pool/aggregate or coarsely categorise potentially identifiable information in any dissemination of research findings.
Publications
Karampatakis GD, Wood HE, Griffiths CJ, Taylor SJC, Toffolutti V, Bird VJ, Lea NC, Ashcroft RE, Day B, Coulson NS, Panzarasa P, Li X, Sheikh A, Relton C, Sastry N, Watson JS, Marsh V, Mant J, Mihaylova B, Walker N, De Simoni A. Non-randomised feasibility study testing a primary care intervention to promote engagement in an online health community for adults with troublesome asthma: protocol. BMJ Open. 2023 Jul 11;13(7):e073503. doi: 10.1136/bmjopen-2023-073503.
PubMed 37433727Karampatakis GD, Wood HE, Griffiths CJ, Lea NC, Ashcroft RE, Day B, Walker N, Coulson NS, De Simoni A. Ethical and Information Governance Considerations for Promoting Digital Social Interventions in Primary Care. J Med Internet Res. 2023 Sep 27;25:e44886. doi: 10.2196/44886.
PubMed 37756051Karampatakis GD, Kimber S, Wood HE, Griffiths CJ, Taylor SJC, Li X, Day B, Mant J, Relton C, Watson JS, Marsh V, Coulson NS, De Simoni A. Development of the face-to-face component and recruitment strategy of a primary care digital social intervention for patients with asthma: Qualitative focus groups and interviews with stakeholders. Eur J Gen Pract. 2024 Dec;30(1):2407594. doi: 10.1080/13814788.2024.2407594. Epub 2024 Sep 27.
PubMed 39329323Karampatakis GD, Wood HE, Griffiths CJ, Taylor SJ, Toffolutti V, Bird VJ, Lea NC, Ashcroft R, Coulson NS, Panzarasa P, Li X, Sheikh A, Relton C, Sastry N, Watson JS, Mant J, Marsh V, Day B, Mihaylova B, Walker N, De Simoni A. Randomised controlled trial to measure effectiveness and cost-effectiveness of a digital social intervention promoted by primary care clinicians to adults with asthma to improve asthma control: protocol. BMJ Open. 2025 Sep 11;15(9):e104367. doi: 10.1136/bmjopen-2025-104367.
PubMed 40940055
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring Whether Promotion of a Digital Social Intervention by Primary Care Healthcare Professionals and Subsequent Engagement With Online Peer Support Improves Health and Well-being of Patients With Asthma and is Cost-effective: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06849245
- Acronym / sponsor ID
- ADHOC / 349517
- Conditions
- Asthma Intermittent, Uncontrolled
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Queen Mary University of LondonUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom, City, University of London, University of Cambridge, University of Edinburgh, University of Nottingham, University of Surrey, St George's, University of London, Asthma UK
- Study start
- 25 Feb 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 27 Feb 2025 (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.
The goal of this study is to deliver a definitive randomised controlled trial to measure the effectiveness and assess cost-effectiveness of a digital social intervention for patients with asthma, composed of promoting engagement with online peer support in a primary care consultation, followed by engagement with online peer support for 12 months. The main questions/objectives this study aims to answer/address are:
- Does promoting engagement with an online health community in primary care help people with troublesome asthma to experience fewer asthma symptoms?
- To assess cost-effectiveness of the intervention (including quality of life, well-being, use of healthcare services etc); stakeholder satisfaction (patients and healthcare professionals) with the intervention; fidelity of protocol delivery; context in which positive outcomes can be triggered.
Detailed description
Patients with troublesome asthma, from 50-70 UK general practices, who might consider seeking advice online will be identified through a short online survey. The survey will include an asthma control test (ACT) questionnaire, a question about the network of support they have with their asthma, whether they are members of another existing online health community and whether they would be interested in taking part in a research study involving engagement in an asthma online health community (if randomised to the intervention arm).
Patients meeting the eligibility criteria will be asked to attend a one-to-one consultation with a healthcare professional at their general practice, who will randomise them using a randomisation tool and subsequently deliver the intervention encouraging them to engage with the asthma online health community or provide usual primary care, respectively. Participants of the intervention arm will be given a username and password for the Asthma + Lung UK online health community and shown how to login to the online health community. Participants will be asked to complete an online questionnaire at this consultation and again 12 months later. The consultation should take 30-45 minutes and completing the data-collection questionnaire 12 months later should take around 10 minutes.
During the 12-month period after the consultation, patients will be phoned by members of the research team every 3 months to collect data through an ACT questionnaire as well as volume of asthma exacerbations and associated healthcare utiilisation (primary and secondary care attendances) within last 3 months. Monthly text messages will also be sent to participants in the intervention arm who have consented, reminding them to engage with the online health community. The final follow-up questionnaire will include questions about how well their asthma is controlled, anxiety and depression, taking their asthma medication, and quality of life. Subject to participants' consent, the investigators will also endeavour to extract data from healthcare records about asthma exacerbations and use of primary and secondary care health services during the 12-month follow-up period (for both control and intervention arm participants). This data will be obtained from 'Discovery' for practices in North-East London. 'Discovery' is a clinical partnership project in East London, run by the Clinical Effectiveness Group at Queen Mary University of London and setting out to link primary and secondary care records, by creating a single database. The Clinical Effectiveness Group extracts data in an anonymised format. For practices in other parts of the UK, NHS Digital will be used to obtain data from healthcare records, and respective protocols and policies will be followed.
Data on intervention arm participants' use of the Asthma + Lung UK OHC during the study period will be collected and analysed, subject to consent, including the amount of engagement (number of days, hours/day etc.), community/ies joined, number of logins, number of likes, and time spent on pages, as well as the content of any public posts made by participants (private messages sent on the OHC will not be accessed or analysed).
At the end of the 12-month follow-up period, one-to-one interviews will be carried out with approximately 25 of the participating patients and approximately 15 of the HCPs involved in the study. Exact numbers will be determined by the point of data saturation being reached, with further interviewees being recruited if necessary. A convenience sample of participants will be invited (by email/text/phone) to take part in this one-off interview, which will last around one hour. Interviews will be carried out by a member of the research team and take place remotely via an appropriate online platform (Zoom or Microsoft Teams). During the interview, participants will be asked a series of questions (from a pre-determined list) exploring their views about their involvement in the study. Interviews will be audio recorded (after securing participants' consent - relevant field in the consent form) for subsequent analysis.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A general practice-based healthcare professional will carry out the study-related consultation (see 'Arms and Interventions' section below) and randomise participants to either the intervention or control group. Healthcare professionals will open a separate REDCap database to obtain the (automatically-generated) group assignment for the patient - either intervention or control - and will deliver the rest of the consultation accordingly.
| Arm | Type | Receives |
|---|---|---|
| Intervention arm in the ADHOC Trial (about 300 patients randomised to the intervention arm) | Experimental | Behavioral: A digital social intervention by primary care cliniciansA general practice-based healthcare professional will carry out the consultation and randomise participants to either the intervention or control group. Healthcare professionals will open a separate REDCap database to obtain the (automatically-generated) group assignment for the patient - either intervention or control - and will deliver the rest of the consultation accordingly. The intervention will consist of a one-off, face-to-face consultation with a practice-based clinician, followed by engagement with the Asthma + Lung UK online health community. The intervention will be delivered at the general practice with which each participant is registered. |
| Control arm (about 300 patients randomised to the control arm) | No intervention | –Control group patients will receive usual care alone, without any reference to online health communities and online peer support. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Be adult asthma patients (aged 18 to 99) who have expressed their interest in digital social interventions in the recruitment survey.
- Report troublesome asthma (i.e. an ACT score of less than 20) in the recruitment survey).
- Be competent to consent for themselves, as determined by the healthcare professional delivering the consultation.
- There are no specific criteria for selecting participants for the exit interviews (a convenience sample of patients and clinicians will be used and recruitment will continue until data saturation).
Key exclusion criteria (5 listed)
- Patients who are already members of the Asthma + Lung UK online health community or other asthma online health communities/Facebook groups (i.e. general use of social media will not prevent participation).
- Palliative or end of life patients.
- Patients receiving institutional long-term care (receiving total care in residential homes or living in nursing homes).
- Patients considered unsuitable to take part in the study by their general practitioners/nurses.
- There are no specific criteria for selecting participants for the exit interviews (a convenience sample of patients and clinicians will be used and recruitment will continue until data saturation).
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 |
|---|---|---|
| A digital social intervention by primary care clinicians* Signposting to the online health community by explaining different sections of the website. * Introducing norms and values for passive (just reading) and active (writing posts) participation. * Motivation for engagement with the online health community, emphasising that it could be used ad hoc (e.g. when feeling unwell, or when they need information or emotional support). * Problem solving with respect to any difficulties/concerns. * Signing patients up to the online health community, by explaining terms and conditions. * Explaining the differences between posting publicly and privately (public posts are shared with third parties whereas private messages to other users are not shared). * Collection of baseline measures. Data will be entered into the study's online database. Patients will leave the consultation with a leaflet summarising all procedural matters in relation to signing up with the online health community and a reminder of their username and password. | Behavioural | Intervention arm in the ADHOC Trial (about 300 patients randomised to the intervention arm) |
Primary outcome
Control of asthma
Time frame: Baseline and very three months in a 12 month follow-up period
Control of asthma will be self-reported by patients through an Asthma Control Test (ACT) questionnaire; minimum value: 5, maximum value: 25; higher scores indicate better asthma control.
21 secondary outcomes
Anxiety
Time frame: Baseline and at the end of a 12 month follow-up period
Depression
Time frame: Baseline and at the end of a 12 month follow-up period
Self-efficacy
Time frame: Baseline and at the end of a 12 month follow-up period
Health-related quality of life
Time frame: Baseline and very three months in a 12 month follow-up period
Adherence to medications
Time frame: Baseline and at the end of a 12 month follow-up period
Number of asthma exacerbations over last 3 months
Time frame: Baseline and very three months in a 12 month follow-up period
Primary and secondary care use over last 3 months
Time frame: Baseline and very three months in a 12 month follow-up period
Cost-effectiveness in relation to use of online health communities (likely a Markov model), including resource requirements, and costs for development, moderation, governance, and clinical oversight of online health communities
Time frame: Calculations/estimations at various time-points during a 12 month follow-up period
Amount of online health community engagement (for intervention arm participants)
Time frame: End of a 12 month follow-up period
Type (passive versus active) of online health community engagement (for intervention arm participants)
Time frame: End of a 12 month follow-up period
Amount of time spent on the online health community (for intervention arm participants)
Time frame: End of a 12 month follow-up period
Number of communities joined (for intervention arm participants)
Time frame: End of a 12 month follow-up period
Number of logins to the online health community (for intervention arm participants)
Time frame: End of a 12 month follow-up period
Number of likes on pages/posts within the online health community platform (for intervention arm participants)
Time frame: End of a 12 month follow-up period
Time spent on pages within the online health community (for intervention arm participants)
Time frame: End of a 12 month follow-up period
Public posts of the participants of the intervention arm within the online health community
Time frame: End of a 12 month follow-up period
Time of each public post in the online health community by the intervention arm participants
Time frame: End of a 12 month follow-up period
Discussion thread of each public post in the online health community by the intervention arm participants
Time frame: End of a 12 month follow-up period
User details in each discussion thread in the online health community in which one of the intervention arm participants was involved
Time frame: End of a 12 month follow-up period
Experience of patients participating in the study
Time frame: End of a 12 month follow-up period
Experience of clinicians carrying out the study-related consultations
Time frame: End of a 12 month follow-up period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- Background: PubMed 37433727Karampatakis GD, Wood HE, Griffiths CJ, Taylor SJC, Toffolutti V, Bird VJ, Lea NC, Ashcroft RE, Day B, Coulson NS, Panzarasa P, Li X, Sheikh A, Relton C, Sastry N, Watson JS, Marsh V, Mant J, Mihaylova B, Walker N, De Simoni A. Non-randomised feasibility study testing a primary care intervention to promote engagement in an online health community for adults with troublesome asthma: protocol. BMJ Open. 2023 Jul 11;13(7):e073503. doi: 10.1136/bmjopen-2023-073503.
- Background: PubMed 37756051Karampatakis GD, Wood HE, Griffiths CJ, Lea NC, Ashcroft RE, Day B, Walker N, Coulson NS, De Simoni A. Ethical and Information Governance Considerations for Promoting Digital Social Interventions in Primary Care. J Med Internet Res. 2023 Sep 27;25:e44886. doi: 10.2196/44886.
- Background: PubMed 39329323Karampatakis GD, Kimber S, Wood HE, Griffiths CJ, Taylor SJC, Li X, Day B, Mant J, Relton C, Watson JS, Marsh V, Coulson NS, De Simoni A. Development of the face-to-face component and recruitment strategy of a primary care digital social intervention for patients with asthma: Qualitative focus groups and interviews with stakeholders. Eur J Gen Pract. 2024 Dec;30(1):2407594. doi: 10.1080/13814788.2024.2407594. Epub 2024 Sep 27.
- Background: PubMed 40940055Karampatakis GD, Wood HE, Griffiths CJ, Taylor SJ, Toffolutti V, Bird VJ, Lea NC, Ashcroft R, Coulson NS, Panzarasa P, Li X, Sheikh A, Relton C, Sastry N, Watson JS, Mant J, Marsh V, Day B, Mihaylova B, Walker N, De Simoni A. Randomised controlled trial to measure effectiveness and cost-effectiveness of a digital social intervention promoted by primary care clinicians to adults with asthma to improve asthma control: protocol. BMJ Open. 2025 Sep 11;15(9):e104367. doi: 10.1136/bmjopen-2025-104367.
- Individual participant dataSharing planned: No. Data from individual participants will not be shared. Participants will not be individually identifiable from any research outputs. 'Pseudonymisation of data' will be the policy for ensuring confidentiality. All participants will be coded, by allocating them unique participation codes. The association between participation codes and names will be contained on a Word/Excel document and will be stored on a password-protected computer at Queen Mary University of London. Any electronic documents or hard copies of data collected from participants will only be accessible to the research team. Only members of the research team will have access to associations between names and participation codes. Every attempt will be made to pool/aggregate or coarsely categorise potentially identifiable information in any dissemination of research findings.
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.
Georgios Karampatakis, PhD contact
Anna De Simoni, PhD principal investigator
Clinical Reader in Primary Care Research, Queen Mary University of London
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A digital social intervention by primary care clinicians in people with Asthma Intermittent, Uncontrolled, run by Queen Mary University of London at 5 sites 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 5 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anna De Simoni, PhD (+442078822520, a.desimoni@qmul.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Control of asthma (time frame: Baseline and very three months in a 12 month follow-up period). 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 NCT06849245, which also lists 4 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 19 Nov 2025.