SIQ-UC and SIQ-CD Study
Research type
Research Study
Full title
Cognitive Interviews and Psychometric Validation of the Symptoms and Impacts Questionnaire for Ulcerative Colitis (SIQ-UC) and Symptoms and Impacts Questionnaire for Crohn’s disease (SIQ-CD)
IRAS ID
302828
Contact name
Gordon Moran
Contact email
Sponsor organisation
Alimentiv Inc
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
1 years, 2 months, 31 days
Research summary
The lack of fully validated Patient reported outcomes (PROs) (Information that comes directly from the patient, example a description of symptoms and how the disease or treatment affects their well-being, for ulcerative colitis (UC) and Crohn’s disease (CD) has led the US Food and Drug Administration and European Medicines Agency to provide guidance on interim PROs to be used in Inflammatory bowel disease (IBD) trials, until a fully developed PRO is available.
We have recently developed 2 draft PROs: the Symptoms and Impacts Questionnaire for UC (SIQ-UC) and the Symptoms and Impacts Questionnaire for CD (SIQ-CD). These PROs were developed based on patients with UC and CD using a process by which symptoms and impacts emerge using open-ended questions in an interview setting and cognitive debriefing methods to ensure appropriateness and comprehensiveness.
The purpose of this study is to assess how well the SIQ-CD and the SIQ-UC evaluate the symptoms experienced by patients.
This study will involve participants in Canada and the UK.
This study is divided into 2 parts: Part 1 and Part 2. Part 1 was conducted in Canada and completed in January 2023. We would like to run Part 2 of the study in the United Kingdom.
We are aiming to recruit 120 participants diagnosed with CD and 120 participants diagnosed with UC in Part 2 of this study, participants will complete a 14-day screening period where data will be collected to assess participants' disease severity and extent. At the completion of the screening period, the Study Doctor will contact the participants to confirm if they can be enrolled in the study, depending on the recruitment target quotas established for the study.
Participants who can continue will complete an electronic diary of disease symptoms, including questionnaire and scales, for 7 days. Participants will complete the electronic diary and questionnaires using a study-dedicated platform. The first 40 participants with UC and 40 participants with CD enrolled in the study will complete the electronic diary and questionnaires for an additional 7 consecutive days (14 days total). During the study, Alimentiv will monitor diary completion to assess participant compliance and data quality. The number of participants required to complete the diary for 14 days may be increased at the discretion of the sponsor to ensure sufficient data is collected to meet the study objectives.
Participation will involve one or two visits to the study center.
After the completion of this study, participants will continue with their regular care.
The study is funded by Alimentiv.REC name
London - Westminster Research Ethics Committee
REC reference
23/PR/1374
Date of REC Opinion
23 Jan 2024
REC opinion
Further Information Favourable Opinion