Skip to main content
OpenTrials
Completed

NCT Number: NCT05829265

Feasibility of an Asthma Online Social Intervention

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?

Completed

Looking for future studies?

Notify Me

Key information

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CRN North Thames

London, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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).

Treatment and study plan

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).

Primary outcomes

  1. Number of patients on the asthma register in the recruited practices

    Time frame: Baseline

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

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

    Time frame: Through study completion, an average of 1 year

    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.

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

    Time frame: Through study completion, an average of 1 year

    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.

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

    Time frame: Through study completion, an average of 1 year

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

  5. 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)

    Time frame: Through study completion, an average of 1 year

    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.

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

    Time frame: Through study completion, an average of 1 year

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

  7. Proportion of missing data (by outcome measure)

    Time frame: Through study completion, an average of 1 year

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

  8. Experience of patients receiving the intervention

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

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

  9. Experience of clinicians delivering the intervention

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

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

Secondary outcomes

  1. Control of asthma

    Time frame: Baseline and at three months from intervention receipt.

    Control of asthma will be self-reported by patients through an Asthma Control Test (ACT) questionnaire.

  2. Adherence to medications

    Time frame: Baseline and at three months from intervention receipt.

    Adherence to medications will be self-reported by patients through a MARS-10 questionnaire.

  3. Number of asthma exacerbations over last 3 months

    Time frame: Baseline and at three months from intervention receipt.

    Asthma exacerbations will be self-reported by patients through a bespoke question.

  4. Health-related quality of life

    Time frame: Baseline and at three months from intervention receipt.

    Health-related quality of life will be self-reported by patients through an EQ-5D-5L questionnaire.

  5. Primary and secondary care use over last 3 months

    Time frame: Baseline and at three months from intervention receipt.

    Care use will be self-reported by patients through a bespoke question.

  6. Time off work to seek care and/or due to asthma over last 3 months

    Time frame: Baseline and at three months from intervention receipt.

    Time off work will be self-reported by patients through a bespoke question.

  7. Depression

    Time frame: Baseline and at three months from intervention receipt.

    Depression will be self-reported by patients through a PHQ-8 questionnaire.

  8. Anxiety

    Time frame: Baseline and at three months from intervention receipt.

    Anxiety will be self-reported by patients through a GAD-7 questionnaire.

  9. Self-efficacy

    Time frame: Baseline and at three months from intervention receipt.

    Self-efficacy will be self-reported by patients through the General Self-Efficacy Scale.

  10. Amount of OHC engagement

    Time frame: Three months post intervention receipt.

    Amount of engagement with OHC will be self-reported by patients through a bespoke question.

  11. Type (passive versus active) of OHC engagement

    Time frame: Three months post intervention receipt.

    Type of engagement with OHC will be self-reported by patients through a bespoke question.

  12. Number of asthma exacerbations over last 3 months

    Time frame: Baseline and at three months from intervention receipt

    Exacerbations will be obtained from general practice records and data from the British Health Service (NHS)

  13. Primary and secondary healthcare service utilisation over last 3 months

    Time frame: Baseline and at three months from intervention receipt

    Number of consultations in general practices, as well as number of hospital attendances and admissions, will be obtained from general practice records and data from NHS.

  14. Costs associated with primary and secondary healthcare service utilisation over last 3 months

    Time frame: Baseline and at three months from intervention receipt

    Costs associated with primary care and hospital attendances, as obtained from general practice records and NHS data, will be calculated through economic models.

  15. Amount of time spent on the OHC

    Time frame: Three months post intervention receipt

    Amount of time spent on the OHC will be provided to the research team by the manager of the ALUK OHC

  16. Number of communities joined

    Time frame: Three months post intervention receipt

    Number of communities joined will be provided to the research team by the manager of the ALUK OHC

  17. Number of logins to the OHC

    Time frame: Three months post intervention receipt

    Number of logins will be provided to the research team by the manager of the ALUK OHC

  18. Number of likes on pages/posts within the OHC platform

    Time frame: Three months post intervention receipt

    Number of likes will be provided to the research team by the manager of the ALUK OHC

  19. Time spent on pages within the OHC

    Time frame: Three months post intervention receipt

    Time spent on pages will be provided to the research team by the manager of the ALUK OHC

  20. Public posts of the 50 participants within the OHC

    Time frame: Three months post intervention receipt

    Public posts will be provided to the research team by the manager of the ALUK OHC

  21. Time of each public post in the OHC by the 50 participants

    Time frame: Three months post intervention receipt

    Time of posts will be provided to the research team by the manager of the ALUK OHC

  22. Discussion thread of each public post in the OHC by the 50 participants

    Time frame: Three months post intervention receipt

    Discussion threads of each post will be provided to the research team by the manager of the ALUK OHC

  23. User details in each discussion thread in the OHC in which one of the 50 participants was involved

    Time frame: Three months post intervention receipt

    User details in each discussion thread will be provided to the research team by the manager of the ALUK OHC

  24. Time to deliver the intervention

    Time frame: Baseline

    This will be recorded by clinicians at the time of delivering the intervention.

Sponsors and collaborators

Lead sponsor

Queen Mary University of London

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Apr 25, 2023
Registry last updated
Dec 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.