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

NCT04597905 | Completed

• 2 other identifiers: IBD-5013U1111-1259-3241
• Study Type: observational
• Target: 686
• Locations: 1 country
• Sites: 1

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.

Conditions

Crohn Disease; Colitis, Ulcerative; Inflammatory Bowel Diseases

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (1)

• Partworth Utilities for Participants With CD and UC

  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.

  20 minutes after one time-survey start

Secondary Outcomes (8)

• Partworth Utilities for Subgroup Participants With CD and UC

  20 minutes after one time-survey start

• Number of Participants Categorized by Characteristics Based on Interaction With the Administration Attribute

  20 minutes after one time-survey start

• Assessment of Latent Classes and Respective Partworth Utilities

  20 minutes after one time-survey start

• Percentage of CD and UC Participants who Switched Their Treatment

  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

Study Arms (2)

CD Participants

Participants diagnosed with CD from the 7 participating countries will take part in survey to collect data regarding their preferences towards the attributes of treatments based on DCE survey with advanced therapies for IBD, including safety and efficacy profiles, frequency and RoA in a real-world setting and data collection will be conducted in a real-world setting via an online self-reported questionnaire hosted on the Carenity platform, an international patient community.

UC Participants

Participants diagnosed with UC from the 7 participating countries will take part in survey to collect data regarding theirpreferences towards the attributes of treatments based on DCE survey with advanced therapies for IBD, including safety and efficacy profiles, frequency and RoA in a real-world setting and data collection will be conducted in a real-world setting via an online self-reported questionnaire hosted on the Carenity platform, an international patient community.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants living with CD or UC, currently or previously treated for their condition.

You may qualify if:

• \. Self-reported suffering from CD or UC.

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• Takeda: lead

Study Sites (1)

Carenity

Paris, 75008, France

Location

MeSH Terms

Conditions

Crohn Disease; Colitis, Ulcerative; Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Study Officials

• Medical Director

  Takeda

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2020
• First Posted: October 22, 2020
• Study Start: October 21, 2020
• Primary Completion: January 31, 2021
• Study Completion: January 31, 2021
• Last Updated: February 11, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

Locations

FR (1)