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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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German Clinical Trials Register |
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Last refreshed on:
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8 April 2024 |
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Main ID: |
DRKS00009858 |
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Date of registration:
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19/01/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Understanding the impact of Ulcerative Colitis and its associated disease burden on patients
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Scientific title:
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Understanding the impact of Ulcerative Colitis and its associated disease burden on patients
- ICONIC |
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Date of first enrolment:
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06/10/2015 |
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Target sample size:
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1800 |
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Recruitment status: |
Complete |
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URL:
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http://drks.de/search/en/trial/DRKS00009858 |
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Study type:
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observational |
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Study design:
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Allocation: ; Masking: ; Control: ; Assignment: ; Study design purpose: other
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Phase:
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Countries of recruitment
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Argentina
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Austria
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Bosnia & Herzegovina
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Bulgaria
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Canada
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Chile
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Colombia
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Croatia
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Czechia
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Egypt
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Estonia
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France
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Germany
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Greece
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Ireland
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Israel
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Italy
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Japan
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Kuwait
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Mexico
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Portugal
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Romania
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Russia
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Saudi Arabia
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Serbia
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Slovakia
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Slovenia
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South Africa
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Spain
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Sweden
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Turkey
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Ukraine
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United Kingdom
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Venezuela
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Contacts
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Name:
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Stefan
Rath |
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Address:
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Mainzer Str. 81
65189
Wiesbaden
Germany |
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Telephone:
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0611 1720 3554 |
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Email:
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stefan.rath@abbvie.com |
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Affiliation:
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AbbVie Deutschland GmbH & Co. KG |
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Name:
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Stefan
Rath |
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Address:
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Mainzer Str. 81
65189
Wiesbaden
Germany |
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Telephone:
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0611 1720 3554 |
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Email:
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stefan.rath@abbvie.com |
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Affiliation:
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AbbVie Deutschland GmbH & Co. KG |
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Key inclusion & exclusion criteria
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Inclusion criteria: • Patients aged = 18 years who have been diagnosed with Ulcerative Colitis = 12 months prior to study inclusion
• Signed a patient authorization form to use and disclose personal health information
Exclusion criteria: None
Age minimum:
18 Years
Age maximum:
None
Gender:
All
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Health Condition(s) or Problem(s) studied
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K51.9
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Ulcerative colitis, unspecified
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K51.9
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Intervention(s)
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Group 1: This observational study will be performed in a prospective, 24-month follow-up, noninterventional format in UC patients. Patients will be asked to complete five short questionnaires or visual representations to provide an evalution of their perceived illness associated with disease, clinical symptom perception, levels of worry, anxiety and depression and quality of life.
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Primary Outcome(s)
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• To evaluate Pictorial Representation of Illness and Self Measure (PRISM) as an assessment tool for perceived disease-associated suffering in UC patients, by assessing correlation with Short quality of life in inflammatory Bowel Disease Questionnaire (SIBDQ) and Patient Health Questionnaire (PHQ-9) (quality of life), according to geographical location and disease severity.
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Secondary Outcome(s)
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• To describe the multi-faceted burden of disease in recently diagnosed Ulcerative Colitis patients.
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Source(s) of Monetary Support
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AbbVie Deutschland GmbH & Co. KG
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Ethics review
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Status: Approved
Approval date: 08/09/2015
Contact:
ek@aekb.de
Ethik-Kommission der Ärztekammer Berlin
(+49)30-408062601
ek@aekb.de
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