Εffectiveness of a Digital Social Intervention in Primary Care

NCT06849245 | Recruiting

• 1 other identifier: 349517
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 5

Brief 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 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.

Conditions

Asthma Intermittent, Uncontrolled

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and very three months in a 12 month follow-up period

Secondary Outcomes (21)

• Anxiety

  Baseline and at the end of a 12 month follow-up period

• Depression

  Baseline and at the end of a 12 month follow-up period

• Self-efficacy

  Baseline and at the end of a 12 month follow-up period

• Health-related quality of life

  Baseline and very three months in a 12 month follow-up period

• Adherence to medications

  Baseline and at the end of a 12 month follow-up period

Study Arms (2)

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.

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.

Interventions

A digital social intervention by primary care clinicians BEHAVIORAL

* 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.

Intervention arm in the ADHOC Trial (about 300 patients randomised to the intervention arm)

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Queen Mary University of London: lead
• National Institute for Health Research, United Kingdom: collaborator
• City, University of London: collaborator
• University of Cambridge: collaborator
• University of Edinburgh: collaborator
• University of Nottingham: collaborator
• University of Surrey: collaborator
• St George's, University of London: collaborator
• Asthma UK: collaborator

Study Sites (5)

South West Peninsula Regional Research Delivery Network

Exeter, United Kingdom

NOT YET RECRUITING

East Midlands Regional Research Delivery Network

Leicester, United Kingdom

RECRUITING

North London Regional Research Delivery Network

London, United Kingdom

RECRUITING

North East and North Cumbria

Newcastle upon Tyne, United Kingdom

RECRUITING

East of England Regional Research Delivery Network

Norwich, United Kingdom

RECRUITING

Related Publications (4)

• 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.

  PMID: 37433727 BACKGROUND

• 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.

  PMID: 37756051 BACKGROUND

• 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.

  PMID: 39329323 BACKGROUND

• 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.

  PMID: 40940055 BACKGROUND

Study Officials

• Anna De Simoni, PhD

  Clinical Reader in Primary Care Research, Queen Mary University of London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna De Simoni, PhD

CONTACT

+442078822520; a.desimoni@qmul.ac.uk

Georgios Karampatakis, PhD

CONTACT

g.karampatakis@qmul.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Masking is not possible.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 27, 2025
• First Posted: February 27, 2025
• Study Start: February 25, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: November 19, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (5)