CRN North Thames
London, United Kingdom
NCT Number: NCT05829265
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?
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Notify Me16 year and older
All sexes
Observational
London, United Kingdom
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.
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:
Exclusion criteria
Patients who are
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:
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.
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.
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.
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.
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.
Time frame: Through study completion, an average of 1 year
This proportion will be based on data from the study's database.
Time frame: Through study completion, an average of 1 year
This proportion will be based on data from the study's database.
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.
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.
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.
Time frame: Baseline and at three months from intervention receipt.
Adherence to medications will be self-reported by patients through a MARS-10 questionnaire.
Time frame: Baseline and at three months from intervention receipt.
Asthma exacerbations will be self-reported by patients through a bespoke question.
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.
Time frame: Baseline and at three months from intervention receipt.
Care use will be self-reported by patients through a bespoke question.
Time frame: Baseline and at three months from intervention receipt.
Time off work will be self-reported by patients through a bespoke question.
Time frame: Baseline and at three months from intervention receipt.
Depression will be self-reported by patients through a PHQ-8 questionnaire.
Time frame: Baseline and at three months from intervention receipt.
Anxiety will be self-reported by patients through a GAD-7 questionnaire.
Time frame: Baseline and at three months from intervention receipt.
Self-efficacy will be self-reported by patients through the General Self-Efficacy Scale.
Time frame: Three months post intervention receipt.
Amount of engagement with OHC will be self-reported by patients through a bespoke question.
Time frame: Three months post intervention receipt.
Type of engagement with OHC will be self-reported by patients through a bespoke question.
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)
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.
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.
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
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
Time frame: Three months post intervention receipt
Number of logins will be provided to the research team by the manager of the ALUK OHC
Time frame: Three months post intervention receipt
Number of likes will be provided to the research team by the manager of the ALUK 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
Time frame: Three months post intervention receipt
Public posts will be provided to the research team by the manager of the ALUK OHC
Time frame: Three months post intervention receipt
Time of posts will be provided to the research team by the manager of the ALUK OHC
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
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
Time frame: Baseline
This will be recorded by clinicians at the time of delivering the intervention.
Queen Mary University of London
Other
Non-randomised Feasibility Study Testing a Primary Care Intervention to Promote Engagement in an Online Health Community (OHC) for Adults With Troublesome Asthma
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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.
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