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| Name | Class |
|---|---|
| National Institute for Health Research, United Kingdom | OTHER_GOV |
| City, University of London | OTHER |
| University of Cambridge | OTHER |
| University of Edinburgh |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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:
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Control of asthma | Control of asthma will be self-reported by patients through an Asthma Control Test (ACT) questionnaire. | Baseline and at three months from intervention receipt. |
| Adherence to medications |
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Inclusion Criteria:
Eligibility criteria for receiving the intervention in the feasibility study:
Exclusion Criteria:
Patients who are
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Anna De Simoni, PhD | Clinical Reader in Primary Care Research, Queen Mary University of London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CRN North Thames | London | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37433727 | Background | 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. | |
| 37756051 |
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Data from individual participants will not be shared. Participants will not be individually identifiable from any research outputs. 'Pseudonymisation of data' will be the policy for ensuring confidentiality. All participants will be coded, by allocating them unique participation codes. The association between participation codes and names will be contained on a Word/Excel document and will be stored on a password-protected computer at Queen Mary University of London. Any electronic documents or hard copies of data collected from participants will only be accessible to the research team. Only members of the research team will have access to associations between names and participation codes. Every attempt will be made to pool/aggregate or coarsely categorise potentially identifiable information in any dissemination of research findings.
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| OTHER |
| University of Nottingham | OTHER |
| University of Surrey | OTHER |
| St George's, University of London | OTHER |
| Asthma UK | OTHER |
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|
| 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. |
Adherence to medications will be self-reported by patients through a MARS-10 questionnaire.
| Baseline and at three months from intervention receipt. |
| Number of asthma exacerbations over last 3 months | Asthma exacerbations will be self-reported by patients through a bespoke question. | Baseline and at three months from intervention receipt. |
| Health-related quality of life | Health-related quality of life will be self-reported by patients through an EQ-5D-5L questionnaire. | Baseline and at three months from intervention receipt. |
| Primary and secondary care use over last 3 months | Care use will be self-reported by patients through a bespoke question. | Baseline and at three months from intervention receipt. |
| Time off work to seek care and/or due to asthma over last 3 months | Time off work will be self-reported by patients through a bespoke question. | Baseline and at three months from intervention receipt. |
| Depression | Depression will be self-reported by patients through a PHQ-8 questionnaire. | Baseline and at three months from intervention receipt. |
| Anxiety | Anxiety will be self-reported by patients through a GAD-7 questionnaire. | Baseline and at three months from intervention receipt. |
| Self-efficacy | Self-efficacy will be self-reported by patients through the General Self-Efficacy Scale. | Baseline and at three months from intervention receipt. |
| Amount of OHC engagement | Amount of engagement with OHC will be self-reported by patients through a bespoke question. | Three months post intervention receipt. |
| Type (passive versus active) of OHC engagement | Type of engagement with OHC will be self-reported by patients through a bespoke question. | Three months post intervention receipt. |
| Number of asthma exacerbations over last 3 months | Exacerbations will be obtained from general practice records and data from the British Health Service (NHS) | Baseline and at three months from intervention receipt |
| Primary and secondary healthcare service utilisation over last 3 months | 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. | Baseline and at three months from intervention receipt |
| Costs associated with primary and secondary healthcare service utilisation over last 3 months | Costs associated with primary care and hospital attendances, as obtained from general practice records and NHS data, will be calculated through economic models. | Baseline and at three months from intervention receipt |
| Amount of time spent on the OHC | Amount of time spent on the OHC will be provided to the research team by the manager of the ALUK OHC | Three months post intervention receipt |
| Number of communities joined | Number of communities joined will be provided to the research team by the manager of the ALUK OHC | Three months post intervention receipt |
| Number of logins to the OHC | Number of logins will be provided to the research team by the manager of the ALUK OHC | Three months post intervention receipt |
| Number of likes on pages/posts within the OHC platform | Number of likes will be provided to the research team by the manager of the ALUK OHC | Three months post intervention receipt |
| Time spent on pages within the OHC | Time spent on pages will be provided to the research team by the manager of the ALUK OHC | Three months post intervention receipt |
| Public posts of the 50 participants within the OHC | Public posts will be provided to the research team by the manager of the ALUK OHC | Three months post intervention receipt |
| Time of each public post in the OHC by the 50 participants | Time of posts will be provided to the research team by the manager of the ALUK OHC | Three months post intervention receipt |
| Discussion thread of each public post in the OHC by the 50 participants | Discussion threads of each post will be provided to the research team by the manager of the ALUK OHC | Three months post intervention receipt |
| User details in each discussion thread in the OHC in which one of the 50 participants was involved | User details in each discussion thread will be provided to the research team by the manager of the ALUK OHC | Three months post intervention receipt |
| Time to deliver the intervention | This will be recorded by clinicians at the time of delivering the intervention. | Baseline |
| 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. |