Εffectiveness of a Digital Social Intervention in Primary Care

Not Applicable

Not yet recruiting

• Conditions: Asthma Intermittent, Uncontrolled

• Registration Number: NCT06849245
• Lead Sponsor: Queen Mary University of London

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.

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 Timeline

• Study First Submitted: 2025-01-27
• Study First Submitted QC: 2025-02-24
• Study First Posted: 2025-02-27
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-15
• Last Update Posted: 2025-04-18
• Study Start: 2025-05
• Primary Completion: 2027-12
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

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).

Exclusion Criteria

• 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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Control of asthma	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.

Secondary Outcome Measures

Name	Time	Method
Anxiety	Baseline and at the end of a 12 month follow-up period	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.
Depression	Baseline and at the end of a 12 month follow-up period	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.
Self-efficacy	Baseline and at the end of a 12 month follow-up period	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.
Health-related quality of life	Baseline and very three months in a 12 month follow-up period	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.
Adherence to medications	Baseline and at the end of a 12 month follow-up period	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.
Number of asthma exacerbations over last 3 months	Baseline and very three months in a 12 month follow-up period	Asthma exacerbations will be self-reported by patients through bespoke questions
Primary and secondary care use over last 3 months	Baseline and very three months in a 12 month follow-up period	Care use will be self-reported by patients through bespoke questions
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	Calculations/estimations at various time-points during a 12 month follow-up period	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.
Amount of online health community engagement (for intervention arm participants)	End of a 12 month follow-up period	Amount of engagement with the online health community will be self-reported by patients through a bespoke question
Type (passive versus active) of online health community engagement (for intervention arm participants)	End of a 12 month follow-up period	Type of engagement with the online health community will be self-reported by patients through a bespoke question
Amount of time spent on the online health community (for intervention arm participants)	End of a 12 month follow-up period	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
Number of communities joined (for intervention arm participants)	End of a 12 month follow-up period	Number of communities joined will be provided to the research team by the manager of the Asthma + Lung UK online health community
Number of logins to the online health community (for intervention arm participants)	End of a 12 month follow-up period	Number of logins will be provided to the research team by the manager of the Asthma + Lung UK online health community
Number of likes on pages/posts within the online health community platform (for intervention arm participants)	End of a 12 month follow-up period	Number of likes will be provided to the research team by the manager of the Asthma + Lung UK online health community
Time spent on pages within the online health community (for intervention arm participants)	End of a 12 month follow-up period	Time spent on pages will be provided to the research team by the manager of the Asthma + Lung UK online health community
Public posts of the participants of the intervention arm within the online health community	End of a 12 month follow-up period	Public posts will be provided to the research team by the manager of the Asthma + Lung UK online health community
Time of each public post in the online health community by the intervention arm participants	End of a 12 month follow-up period	Time of posts will be provided to the research team by the manager of the Asthma + Lung UK online health community
Discussion thread of each public post in the online health community by the intervention arm participants	End of a 12 month follow-up period	Discussion threads of each post will be provided to the research team by the manager of the Asthma + Lung UK online health community
User details in each discussion thread in the online health community in which one of the intervention arm participants was involved	End of a 12 month follow-up period	User details in each discussion thread will be provided to the research team by the manager of the Asthma + Lung UK online health community
Experience of patients participating in the study	End of a 12 month follow-up period	Experiences of patients will be obtained via qualitative interviews with patients
Experience of clinicians carrying out the study-related consultations	End of a 12 month follow-up period	Experiences of clinicians will be obtained via qualitative interviews with clinicians

Trial Locations

Locations (4)

South Central Regional Research Delivery Network; 🇬🇧 Southampton, United Kingdom

North London Regional Research Delivery Network; 🇬🇧 London, United Kingdom

South London Regional Research Delivery Network; 🇬🇧 London, United Kingdom

East of England Regional Research Delivery Network; 🇬🇧 Norwich, United Kingdom