Trials / Recruiting
RecruitingNCT03052283
Development and Validation of a Disease Specific PROM to Assess Abdominal Involvement in Patients With CF (CFAbd-Score)
Evaluation and Validation of a New Questionnaire to Identify and Quantify Abdominal Symptoms in Patients With Cystic Fibrosis Following FDA Guidelines: the CF Abd-Score (Primarily Named JenAbdomen-CF Score)
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 2,000 (estimated)
- Sponsor
- Medizinische Hochschule Brandenburg Theodor Fontane · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- Accepted
Summary
Development, validation and evaluation of a new multimodal questionnaire to assess and quantify the abdominal involvement in patients with the inherited life shortening multi-organ disease Cystic fibrosis. 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.
Detailed description
Development of a multimodal questionnaire considering the FDA guidelines for development of a PROM, the CFAbd-Score * 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
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | Questionnaire Patient Reported Outcome Measure (PROM) | non-interventional |
Timeline
- Start date
- 2017-01-26
- Primary completion
- 2026-12-31
- Completion
- 2027-12-31
- First posted
- 2017-02-14
- Last updated
- 2023-04-04
Locations
2 sites across 1 country: Germany
Source: ClinicalTrials.gov record NCT03052283. Inclusion in this directory is not an endorsement.