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Trials / Completed

CompletedNCT05829265

Feasibility of an Asthma Online Social Intervention

Non-randomised Feasibility Study Testing a Primary Care Intervention to Promote Engagement in an Online Health Community (OHC) for Adults With Troublesome Asthma

Status
Completed
Phase
Study type
Observational
Enrollment
526 (actual)
Sponsor
Queen Mary University of London · Academic / Other
Sex
All
Age
16 Years
Healthy volunteers
Not accepted

Summary

The goal of this observational study is to test the feasibility and acceptability of an online intervention for people with troublesome asthma in primary care, involving a consultation with a primary care clinician to introduce and promote online peer support (i.e. support from other patients with asthma within an established and safe OHC). The main questions this study aims to answer are: * 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

This observational study will involve a non-randomised, mixed-methods, feasibility study, setting out to test and refine a digital social intervention for people with troublesome asthma in primary care. The feasibility study will consist of a number of steps, including a questionnaire survey to identify and recruit eligible patients, intervention delivery, collection of follow-up outcomes, and exit one-to-one interviews with a sample of patients and primary care clinicians. Provided the feasibility study is successful, there are plans to undertake a full randomised controlled trial. 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

Interventions

TypeNameDescription
BEHAVIORALA 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).

Timeline

Start date
2022-12-09
Primary completion
2024-08-31
Completion
2024-08-31
First posted
2023-04-25
Last updated
2024-12-24

Locations

1 site across 1 country: United Kingdom

Source: ClinicalTrials.gov record NCT05829265. Inclusion in this directory is not an endorsement.

Feasibility of an Asthma Online Social Intervention (NCT05829265) · Clinical Trials Directory