Development and Validation of a Disease Specific PROM to Assess Abdominal Involvement in Patients With CF (CFAbd-Score)
NCT ID: NCT03052283
Last Updated: 2023-04-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
2000 participants
OBSERVATIONAL
2017-01-26
2027-12-31
Brief Summary
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In the stepwhise development of the patient reported outcome measures (PROM) repeadedly, CF-patients, their families as well as professionals working in different fields of CF-care will be included.
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Detailed Description
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* Evaluation of reliability of the questionnaire by examining internal consistency and construct validity
* Evaluation of reproducibility of the questionnaire by re-testing of patients
* Assessment of cross-generational applicability of the questionnaire by sub-scoring of age groups
* Evaluation of the responsiveness of the score by comparison with age-matched healthy controls
* Assessment of putative relationships of abdominal symptoms with faecal inflammatory markers
* Assessment of applicability of the questionnaire in other CF centers
* Transfer the CFAbd-Score to other countries and languages
Development and validation of a CF-specific tool for daily assessment of abdominal symptoms (patient diary), the CFAbd-day2day
Development and validation of a CF-specific tool for assessment of abdominal symptoms in children \< 12 years of age, the CFAbd-kid
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Patients with CF
\>2000 in Germany, France, Italy, Spain, Denmark, Belgium, Portugal, GB, Ireland, USA, Australia, Canada, Brazil, Argentina...
Questionnaire Patient Reported Outcome Measure (PROM)
non-interventional
Age-matched healthy controls
\>100 in Germany \>100 in each of the other participating countries
Questionnaire Patient Reported Outcome Measure (PROM)
non-interventional
Interventions
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Questionnaire Patient Reported Outcome Measure (PROM)
non-interventional
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Diagnosis of CF determined by
* a sweat chloride of \>60 mEq/L and/or
* detection of 2 disease causing CFTR mutations with evidence of organ involvement.
Healthy controls:
* Age-matched
Exclusion Criteria
* Lacking ability to cooperate of patients /their families, respectively
Healthy controls:
* Other diseases causing abdominal symptoms (Inflammatory bowel disease (IBD), alpha 1 antitrypsin deficiency, celiac disease, food allergy, gastroenteritis, etc.)
ALL
Yes
Sponsors
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University of Jena
OTHER
Medizinische Hochschule Brandenburg Theodor Fontane
OTHER
Responsible Party
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Prof. Dr. Jochen G. Mainz
Director of the Cystic Fibrosis-Center
Principal Investigators
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Jochen G Mainz, Prof. MD
Role: PRINCIPAL_INVESTIGATOR
Medizinische Hochschule Brandenburg (MHB), University
Locations
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Klinikum Westbrandenburg
Brandenburg, , Germany
Medizinische Hochschule Brandenburg (MHB), University
Brandenburg, , Germany
Countries
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Central Contacts
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Facility Contacts
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References
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Tabori H, Arnold C, Jaudszus A, Mentzel HJ, Renz DM, Reinsch S, Lorenz M, Michl R, Gerber A, Lehmann T, Mainz JG. Abdominal symptoms in cystic fibrosis and their relation to genotype, history, clinical and laboratory findings. PLoS One. 2017 May 4;12(5):e0174463. doi: 10.1371/journal.pone.0174463. eCollection 2017.
Tabori H, Jaudszus A, Arnold C, Mentzel HJ, Lorenz M, Michl RK, Lehmann T, Renz DM, Mainz JG. Relation of Ultrasound Findings and Abdominal Symptoms obtained with the CFAbd-Score in Cystic Fibrosis Patients. Sci Rep. 2017 Dec 12;7(1):17465. doi: 10.1038/s41598-017-17302-4.
Jaudszus A, Zeman E, Jans T, Pfeifer E, Tabori H, Arnold C, Michl RK, Lorenz M, Beiersdorf N, Mainz JG. Validity and Reliability of a Novel Multimodal Questionnaire for the Assessment of Abdominal Symptoms in People with Cystic Fibrosis (CFAbd-Score). Patient. 2019 Aug;12(4):419-428. doi: 10.1007/s40271-019-00361-2.
Jaudszus A, Pfeifer E, Lorenz M, Beiersdorf N, Hipler UC, Zagoya C, Mainz JG. Abdominal Symptoms Assessed With the CFAbd-Score are Associated With Intestinal Inflammation in Patients With Cystic Fibrosis. J Pediatr Gastroenterol Nutr. 2022 Mar 1;74(3):355-360. doi: 10.1097/MPG.0000000000003357.
Mainz JG, Zagoya C, Polte L, Naehrlich L, Sasse L, Eickmeier O, Smaczny C, Barucha A, Bechinger L, Duckstein F, Kurzidim L, Eschenhagen P, Caley L, Peckham D, Schwarz C. Elexacaftor-Tezacaftor-Ivacaftor Treatment Reduces Abdominal Symptoms in Cystic Fibrosis-Early results Obtained With the CF-Specific CFAbd-Score. Front Pharmacol. 2022 Jun 3;13:877118. doi: 10.3389/fphar.2022.877118. eCollection 2022.
Caley LR, Zagoya C, Duckstein F, White H, Shimmin D, Jones AM, Barrett J, Whitehouse JL, Floto RA, Mainz JG, Peckham DG. Diabetes is associated with increased burden of gastrointestinal symptoms in adults with cystic fibrosis. J Cyst Fibros. 2023 Mar;22(2):275-281. doi: 10.1016/j.jcf.2023.01.010. Epub 2023 Jan 27.
Related Links
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Validity and Reliability of a Novel Multimodal Questionnaire for the Assessment of Abdominal Symptoms in People with Cystic Fibrosis (CFAbd-Score).
Other Identifiers
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CFAbd-Score.kid
Identifier Type: OTHER
Identifier Source: secondary_id
CFAbd-day2day
Identifier Type: OTHER
Identifier Source: secondary_id
CFAbd-Score
Identifier Type: -
Identifier Source: org_study_id
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