RC1050 - Dup15q Syndrome Interview Study
Research type
Research Study
Full title
Concept Elicitation Interviews to Inform the Update and Refinement of a Conceptual Model of Dup15q Syndrome
IRAS ID
340502
Contact name
Tara Symonds
Contact email
Sponsor organisation
Roche Products Ltd.
Duration of Study in the UK
0 years, 6 months, 17 days
Research summary
Research Summary - This is an non-interventional, qualitative observational study that asks participants to complete an online screener, and if eligible, to complete a one 60 minute interview with a trained researcher. Total n=5 from the UK. Participants will be caregivers of individuals with Dup15q Syndrome. Recruitment will be done outside of the NHS through a UK Patient Advocacy Group.
Clinical Outcomes Solutions (COS) previously worked with another Sponsor to develop a conceptual model of Dup15q syndrome, referred to as the 2020 draft conceptual model. The 2020 draft model was informed by a qualitative literature review (up to 2019) and interviews with clinicians (n = 3) and patient advocates (n = 2). COS have since conducted an updated literature review (between 2018 to June 2023) in conjunction with Roche which demonstrated that overall, the draft 2020 model remains comprehensive. The initial and current literature review both highlighted the lack of in-depth qualitative studies in Dup15q syndrome, and this further supports the next steps for the project – moving forward to concept elicitation (CE) interviews.
Roche wishes to update and refine the 2020 draft conceptual model through CE
interviews with caregivers in order to inform current and future clinical trials in Dup15q syndrome. This will be complemented with input from a clinical/research expert panel. The symptoms or impacts captured will be collated and cross-walked to the 2020 draft conceptual model, in order to make any necessary updates to the model before finalization.
Lay Summary - Gather insight into caregivers’ perspectives and understanding of the individual they care for/ their child’s Dup15q symptoms and impacts of Dup15q syndrome on the individual’s Health Related Quality Of Life (HRQoL.)
2. Document the language used by caregivers to describe disease-related experiences.
3. Use the information gathered to update the Dup15q syndrome conceptual model. This model will then become the final Dup15q syndrome conceptual model.Has the registry been updated to include summary results?: No
If yes - please enter the URL to summary results:
If no – why not?: No registry for qualitative studies.
Did you follow your dissemination plan submitted in the IRAS application form (Q A51)?: Pending
If yes, describe or provide URLs to disseminated materials:
If pending, date when dissemination is expected: 02/05/2025
If no, explain why you didn't follow it:
Have participants been informed of the results of the study?: No
If yes, describe and/or provide URLs to materials shared and how they were shared:
If pending, date when feedback is expected:
If no, explain why they haven't: The study results will be made available through the Patient Advocacy Group (Dup15q Alliance.)
Have you enabled sharing of study data with others?: Yes
If yes, describe or provide URLs to how it has been shared: https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fclick.pstmrk.it%2F3ts%2Fdup15q.org%252F%2FNBTI%2FP6_5AQ%2FAQ%2Fd25fd6fa-d3fe-4e50-83d7-4bf08d546335%2F1%2F2sNGvrXVhq&data=05%7C02%7Cbrightonandsussex.rec%40hra.nhs.uk%7Cbd2cdbb76d94447beef508dd10784464%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638684830909298043%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=EyAR3QK%2FQgANCvcbRVeD5dOCr3%2FyEzUSjweua2wD0OQ%3D&reserved=0
If no, explain why sharing hasn't been enabled:
Have you enabled sharing of tissue samples and associated data with others?: No
If yes, describe or provide a URL:
If no, explain why: No tissues samples were collected as part of this study.REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
24/PR/0155
Date of REC Opinion
18 Apr 2024
REC opinion
Further Information Favourable Opinion