Εffectiveness of a Digital Social Intervention in Primary Care
NCT ID: NCT06849245
Last Updated: 2025-11-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
600 participants
INTERVENTIONAL
2025-02-25
2027-12-31
Brief Summary
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* 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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Intervention arm in the ADHOC Trial (about 300 patients randomised to the intervention arm)
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.
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.
Control arm (about 300 patients randomised to the control arm)
Control group patients will receive usual care alone, without any reference to online health communities and online peer support.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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).
Exclusion Criteria
* 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).
18 Years
99 Years
ALL
No
Sponsors
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National Institute for Health Research, United Kingdom
OTHER_GOV
City, University of London
OTHER
University of Cambridge
OTHER
University of Edinburgh
OTHER
University of Nottingham
OTHER
University of Surrey
OTHER
St George's, University of London
OTHER
Asthma UK
OTHER
Queen Mary University of London
OTHER
Responsible Party
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Principal Investigators
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Anna De Simoni, PhD
Role: PRINCIPAL_INVESTIGATOR
Clinical Reader in Primary Care Research, Queen Mary University of London
Locations
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South West Peninsula Regional Research Delivery Network
Exeter, , United Kingdom
East Midlands Regional Research Delivery Network
Leicester, , United Kingdom
North London Regional Research Delivery Network
London, , United Kingdom
North East and North Cumbria
Newcastle upon Tyne, , United Kingdom
East of England Regional Research Delivery Network
Norwich, , United Kingdom
Countries
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Central Contacts
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References
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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.
Karampatakis 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.
Karampatakis 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.
Karampatakis 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.
Other Identifiers
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349517
Identifier Type: -
Identifier Source: org_study_id
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