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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COMPLETED
526 participants
OBSERVATIONAL
2022-12-09
2024-08-31
Brief Summary
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* Is the intervention feasible and acceptable to patients?
* Can the research team recruit patients and collect health-related data to identify the impact of this intervention on patients and what are the challenges to pursue further research to evaluate this intervention in a trial?
Detailed Description
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The precise content of the survey is currently being co-developed with stakeholders. However, the research team envisages including questions about participants' demographic and socioeconomic data, asthma symptoms, control and self-management, quality of life, mental wellbeing, health literacy, and interest in digital social interventions. Completion of the survey should take around 15 minutes.
Eligible patients identified through the survey will be invited to receive the intervention (see 'Groups and Interventions' section below). The exact content of the intervention is still being co-developed with patients and clinicians. Clinicians delivering the intervention will be thoroughly trained (through an online workshop/session) on the practicalities of signing patients up to an OHC, including on seeking and recording consent and collecting baseline data. The precise content of training is still being developed in collaboration with various stakeholders.
A number of outcomes, both self-reported and non-self-reported by patients, will be collected (see 'Outcome measures' section below). The self-reported outcome variables will be collected, via an online form designed on RedCap software, at baseline and at six months following the intervention. For the baseline collection, clinicians will add patients' responses to the online form at the time of delivering the intervention. For the follow-up collection, participants will receive a link to the online form, via a text message from the practice with which participants are registered, for self-submission (form completion should take 10-15 minutes).
A sample of patients and clinicians will be invited to participate in a one-to-one, semi-structured interview. Clinicians will be interviewed shortly after delivering the intervention to all recruited patients, whereas patients will be interviewed at the end of the feasibility study (i.e. after the completion of the follow-up period). An interview topic guide composed of open-ended questions and prompts will be used to elicit experiences of delivering/receiving the intervention. Based on individual participants' preferences, interviews will take place either in person (within private meeting or consultation spaces in the general practices) or virtually (via Zoom platform). Interviews should last approximately 30-90 minutes, depending on how much each participant has to share, and will be audio recorded through digital recorders or by using the Cloud function in Zoom. Basic demographic data will be collected at the time of the interview.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Intervention group in the feasibility study.
There will only be one group in the feasibility study (i.e. all 50 patients recruited will receive the intervention).
A digital social intervention by primary care clinicians.
The intervention in this study will involve a structured consultation with a primary care clinician (e.g. a general practitioner (GP) or practice nurse) to promote online peer support, followed by engagement with the OHC of the Asthma + Lung UK (ALUK) charity. The intervention will either be delivered in person (in the general practices) or virtually. The aim is for the intervention to involve a face-to-face, one-off consultation, lasting approximately 30 minutes, during which a primary care clinician will:
* Signpost and sign patients up to the ALUK OHC, by thoroughly explaining terms of conditions of use and providing log in details.
* Introduce norms and values for passive (just reading) and active (writing OHC posts) participation.
* Encourage seeking and offering self-management information and support, by emphasising that the OHC could be used ad hoc (e.g. when feeling unwell, or when there are information or emotional needs).
Interventions
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A digital social intervention by primary care clinicians.
The intervention in this study will involve a structured consultation with a primary care clinician (e.g. a general practitioner (GP) or practice nurse) to promote online peer support, followed by engagement with the OHC of the Asthma + Lung UK (ALUK) charity. The intervention will either be delivered in person (in the general practices) or virtually. The aim is for the intervention to involve a face-to-face, one-off consultation, lasting approximately 30 minutes, during which a primary care clinician will:
* Signpost and sign patients up to the ALUK OHC, by thoroughly explaining terms of conditions of use and providing log in details.
* Introduce norms and values for passive (just reading) and active (writing OHC posts) participation.
* Encourage seeking and offering self-management information and support, by emphasising that the OHC could be used ad hoc (e.g. when feeling unwell, or when there are information or emotional needs).
Eligibility Criteria
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Inclusion Criteria
* Patients with a diagnosis of asthma indicated in online clinical records.
* Aged 16 years and above.
* Have expressed, in the questionnaire survey, interest in receiving a digital social intervention.
* Experience troublesome asthma (i.e. asthma control test (ACT) score of less than 20).
* Sufficiently fluent in English to take part in a consultation and subsequent data collection procedures.
* Competent to consent for themselves, as determined by a qualified primary care healthcare professional.
Exclusion Criteria
* Palliative or end-of-life.
* Receiving institutional long-term care (i.e. receiving total care in residential homes or living in nursing homes).
* Already a member of the ALUK OHC or other asthma OHCs/Facebook groups (general use of social media will not prevent participation).
16 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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CRN North Thames
London, , United Kingdom
Countries
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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.
Other Identifiers
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314672
Identifier Type: -
Identifier Source: org_study_id