Clinical trial NCT05829265: Feasibility of an Asthma Online Social Intervention
Official title: Non-randomised Feasibility Study Testing a Primary Care Intervention to Promote Engagement in an Online Health Community (OHC) for Adults With Troublesome Asthma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma Intermittent, Uncontrolled
Lead sponsor: Queen Mary University of London
Sponsor class: OTHER
Collaborators: name: National Institute for Health Research, United Kingdom
name: City, University of London
name: University of Cambridge
name: University of Edinburgh
name: University of Nottingham
name: University of Surrey
name: St George's, University of London
name: Asthma UK
First posted: 2023-04-25
Enrollment: 526
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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?

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Number of patients on the asthma register in the recruited practices
timeFrame: Baseline
measure: Number of: survey respondents, patients willing and unwilling to receive the intervention, participants who withdraw or have missing data
timeFrame: Through study completion, an average of 1 year
measure: Characteristics of: survey respondents, patients willing and unwilling to receive the intervention, participants who withdraw or have missing data
timeFrame: Through study completion, an average of 1 year
measure: Recruitment rate (i.e. proportion of asthma register and/or survey respondents interested in and eligible for the intervention)
timeFrame: Through study completion, an average of 1 year
measure: 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)
timeFrame: Through study completion, an average of 1 year
measure: Retention rate (i.e. proportion of patients providing valid measures at the end of the follow-up period)
timeFrame: Through study completion, an average of 1 year
measure: Proportion of missing data (by outcome measure)
timeFrame: Through study completion, an average of 1 year
measure: Experience of patients receiving the intervention
timeFrame: Patient experiences will be obtained through study completion (an average of 1 year).
measure: Experience of clinicians delivering the intervention
timeFrame: Clinician experiences will be obtained up to 24 weeks from study's commencement.
Secondary outcomes:
measure: Control of asthma
timeFrame: Baseline and at three months from intervention receipt.
measure: Adherence to medications
timeFrame: Baseline and at three months from intervention receipt.
measure: Number of asthma exacerbations over last 3 months
timeFrame: Baseline and at three months from intervention receipt.
measure: Health-related quality of life
timeFrame: Baseline and at three months from intervention receipt.
measure: Primary and secondary care use over last 3 months
timeFrame: Baseline and at three months from intervention receipt.
measure: Time off work to seek care and/or due to asthma over last 3 months
timeFrame: Baseline and at three months from intervention receipt.
measure: Depression
timeFrame: Baseline and at three months from intervention receipt.
measure: Anxiety
timeFrame: Baseline and at three months from intervention receipt.
measure: Self-efficacy
timeFrame: Baseline and at three months from intervention receipt.
measure: Amount of OHC engagement
timeFrame: Three months post intervention receipt.
measure: Type (passive versus active) of OHC engagement
timeFrame: Three months post intervention receipt.
measure: Number of asthma exacerbations over last 3 months
timeFrame: Baseline and at three months from intervention receipt
measure: Primary and secondary healthcare service utilisation over last 3 months
timeFrame: Baseline and at three months from intervention receipt
measure: Costs associated with primary and secondary healthcare service utilisation over last 3 months
timeFrame: Baseline and at three months from intervention receipt
measure: Amount of time spent on the OHC
timeFrame: Three months post intervention receipt
measure: Number of communities joined
timeFrame: Three months post intervention receipt
measure: Number of logins to the OHC
timeFrame: Three months post intervention receipt
measure: Number of likes on pages/posts within the OHC platform
timeFrame: Three months post intervention receipt
measure: Time spent on pages within the OHC
timeFrame: Three months post intervention receipt
measure: Public posts of the 50 participants within the OHC
timeFrame: Three months post intervention receipt
measure: Time of each public post in the OHC by the 50 participants
timeFrame: Three months post intervention receipt
measure: Discussion thread of each public post in the OHC by the 50 participants
timeFrame: Three months post intervention receipt
measure: User details in each discussion thread in the OHC in which one of the 50 participants was involved
timeFrame: Three months post intervention receipt
measure: Time to deliver the intervention
timeFrame: Baseline
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: CRN North Thames
Study officials:
affiliation: Clinical Reader in Primary Care Research, Queen Mary University of London
name: Anna De Simoni, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.