Ignite Creation Date:
2024-05-06 @ 6:55 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05829265
Status:
RECRUITING
Last Update Posted:
2024-03-19
First Post:
2023-02-21
Brief Title:
Feasibility of an Asthma Online Social Intervention
Sponsor:
Queen Mary University of London
Organization:
Queen Mary University of London
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 ie 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
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 workshopsession 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 ie 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 deliveringreceiving 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
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 workshopsession 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 ie 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 deliveringreceiving 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None