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Feasibility of an Asthma Online Social Intervention

Q

Queen Mary University of London

Status

Completed

Conditions

Asthma Intermittent, Uncontrolled

Treatments

Behavioral: A digital social intervention by primary care clinicians.

Study type

Observational

Funder types

Other

Identifiers

Details and patient eligibility

About

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?

Full 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.

Enrollment

526 patients

Sex

All

Ages

16+ years old

Volunteers

No Healthy Volunteers

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).

Trial design

526 participants in 1 patient group

Intervention group in the feasibility study.
Description:
There will only be one group in the feasibility study (i.e. all 50 patients recruited will receive the intervention).
Treatment:
Behavioral: A digital social intervention by primary care clinicians.

Trial contacts and locations

1

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Central trial contact

Georgios Karampatakis, PhD; Anna De Simoni, PhD

Data sourced from clinicaltrials.gov

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