Paricipant Preferences in the Treatment of Inflammatory Bowel Disease (IBD) in Europe

Completed

• Conditions: Inflammatory Bowel Diseases; Crohn Disease; Colitis, Ulcerative

• Registration Number: NCT04597905
• Lead Sponsor: Takeda

Brief Summary

The purpose of this survey is to describe Crohn's disease (CD) participants' as well as ulcerative colitis (UC) participants' preferences towards the attributes of treatment with advanced therapies for IBD, including safety and efficacy profiles, frequency and route of administration (RoA) in a real-world setting.

Detailed Description

This is a descriptive, observational, cross-sectional survey of participants with IBD. The survey will look into the preferences of participants towards the attributes of treatment with advanced therapies for IBD based on DCE (experimentally designed survey), including safety and efficacy profiles, frequency and RoA in a real-world setting, in European participants living with CD or UC.

The survey will involve data collection in a real-world setting via an online self-reported questionnaire hosted on the Carenity platform, an international participant community.

The survey will enroll approximately 600 participants. Participants will be enrolled in two observational cohorts:

* CD Participants

* UC Participants

This multi-center trial will be conducted in France, the United Kingdom, Italy, Spain, Belgium, Switzerland, the Netherlands.

Study Timeline

• Study First Submitted: 2020-10-19
• Study First Submitted QC: 2020-10-19
• Study Start: 2020-10-21
• Study First Posted: 2020-10-22
• Primary Completion: 2021-01-31
• Study Completion: 2021-01-31
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-10
• Last Update Posted: 2021-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 686

Inclusion Criteria

1. Self-reported suffering from CD or UC.

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Exclusion Criteria

1. Have never been ever treated with prescription medications for CD or UC.

• Should be included in the study only once.
• Data collected from participants who subsequently withdraw their consent will not be included in or will be deleted from the database.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Partworth Utilities for Participants With CD and UC	20 minutes after one time-survey start	Partworth utilities (attribute importance scores and level values) will be evaluated separately for UC and CD in discrete choice experiment's (DCE) conditional logit (CL) models.DCEs:an attribute-based measure of benefit. CL model analyses DCEs.All DCE attributes will be included in CL models.For CD:remission after one year,occurrence of serious adverse effects or events,mild adverse effects or events, long-term remission on maintenance treatment and administration of medication.For UC: corticosteroid-free remission,healing of intestinal mucosa of bowel after one year,long-term remission on continuous treatment and administration of medication.All attributes will be coded as categorical variables;attribute levels will be dummy-coded,whereby omitted categories will be coded:0,omitted category for each attribute will be reference level of partworth utility.Negative partworth utility indicates less desired levels and positive partworth utility indicates more desired levels of attributes.

Secondary Outcome Measures

Name	Time	Method
Mean Evaluation of Preference Rating For Oral Tablet or Pill	20 minutes after one time-survey start	Rating for tablet/pills will be evaluated from 0 to 100 range which signifies least to most preferred.
Partworth Utilities for Subgroup Participants With CD and UC	20 minutes after one time-survey start	Partworth utilities for each pathology, by computing CL models on subgroup of participants based on demographic and medical profiles as well as quality of life criteria. Those subgroups will be created by using the clustering method available within the CL model, which will be conducted for each separated group and then compared using their estimated coefficients.
Number of Participants Categorized by Characteristics Based on Interaction With the Administration Attribute	20 minutes after one time-survey start
Percentage of CD and UC Participants who Switched Their Treatment due to Pain	20 minutes after one time-survey start
Mean Evaluation of Preference Rating for Subcutaneous (SC) Injection With Needle and Without Needle	20 minutes after one time-survey start	Rating for SC injection will be evaluated from 0 to 100 range which signifies least to most preferred.
Assessment of Latent Classes and Respective Partworth Utilities	20 minutes after one time-survey start	Latent classes and respective partworth utilities will be assessed by latent-class multinomial logit (LC-MNL) models. LC-MNL models will identify groups with similar preferences (latent classes), and estimate the probability that each respondent belongs to each class. Logistic regression models will then be applied to determine the association between latent class membership and participant characteristics.
Percentage of CD and UC Participants who Switched Their Treatment	20 minutes after one time-survey start
Mean Evaluation of Preference Rating for Intravenous Infusion	20 minutes after one time-survey start	Rating for intravenous infusion will be evaluated from 0 to 100 range which signifies least to most preferred.

Trial Locations

Locations (1)

Carenity; 🇫🇷 Paris, France