Feasibility of an Asthma Online Social Intervention

NCT05829265 | Completed

• 1 other identifier: 314672
• Study Type: observational
• Target: 526
• Locations: 1 country
• Sites: 1

Brief 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?

Conditions

Asthma Intermittent, Uncontrolled

Outcome Measures

Primary Outcomes (9)

• Number of patients on the asthma register in the recruited practices

  The number of patients on the asthma register will be measured in each recruited general practice, by extracting this information from practice records.

  Baseline

• Number of: survey respondents, patients willing and unwilling to receive the intervention, participants who withdraw or have missing data

  Number of survey respondents and patients willing and unwilling to receive the intervention will be calculated from survey data, whereas number of participants who withdraw or have missing data will be obtained from the study's database.

  Through study completion, an average of 1 year

• Characteristics of: survey respondents, patients willing and unwilling to receive the intervention, participants who withdraw or have missing data

  Characteristics of survey respondents and patients willing and unwilling to receive the intervention will be obtained from survey data, whereas characteristics of participants who withdraw or have missing data will be obtained from the study's database.

  Through study completion, an average of 1 year

• Recruitment rate (i.e. proportion of asthma register and/or survey respondents interested in and eligible for the intervention)

  This proportion will be calculated based on the survey data and clinical records in the general practices used as recruitment sites.

  Through study completion, an average of 1 year

• Uptake rate (i.e. proportion of eligible patients consenting to the intervention and/or actively or passively engaging in the online health community (OHC) for the duration of the study)

  The proportion of patients consenting to the study will be calculated based on data from the survey and the study's database, whereas the proportion of patients engaging with the OHC will be calculated based on OHC activity data.

  Through study completion, an average of 1 year

• Retention rate (i.e. proportion of patients providing valid measures at the end of the follow-up period)

  This proportion will be based on data from the study's database.

  Through study completion, an average of 1 year

• Proportion of missing data (by outcome measure)

  This proportion will be based on data from the study's database.

  Through study completion, an average of 1 year

• Experience of patients receiving the intervention

  Experiences of patients will be obtained via qualitative interviews with patients.

  Patient experiences will be obtained through study completion (an average of 1 year).

• Experience of clinicians delivering the intervention

  Experiences of clinicians will be obtained via qualitative interviews with clinicians.

  Clinician experiences will be obtained up to 24 weeks from study's commencement.

Secondary Outcomes (24)

• Control of asthma

  Baseline and at three months from intervention receipt.

• Adherence to medications

  Baseline and at three months from intervention receipt.

• Number of asthma exacerbations over last 3 months

  Baseline and at three months from intervention receipt.

• Health-related quality of life

  Baseline and at three months from intervention receipt.

• Primary and secondary care use over last 3 months

  Baseline and at three months from intervention receipt.

Study Arms (1)

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).

Behavioral: A digital social intervention by primary care clinicians.

Interventions

A digital social intervention by primary care clinicians. BEHAVIORAL

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).

Intervention group in the feasibility study.

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Three to six general practices in North and East London will act as recruitment sites. In each practice, a GP or nurse will create a list of all adults with a diagnosis of asthma, who are not receiving palliative/end of life or institutional care. These adults will receive a text message inviting them to take part in the online questionnaire survey. Patients fulfilling the inclusion criteria will be identified, via the survey, and invited to receive the intervention. Eligible patients will be purposively sampled so that a range of ethnic/age groups, health literacy levels, ACT score ranges and co-existing conditions are represented in the cohort of patients receiving the intervention.

You may qualify if:

• Eligibility criteria for receiving the intervention in the feasibility study:
• 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.

You may not qualify if:

• Patients who are
• 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).

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 (1)

CRN North Thames

London, United Kingdom

Location

Related Publications (2)

• 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

Study Officials

• Anna De Simoni, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2023
• First Posted: April 25, 2023
• Study Start: December 9, 2022
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2024
• Last Updated: December 24, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)