FaBI: Family burden in Ichthyosis. Translation and psychometric validation of the Family Burden in Ichthyosis (FBI) - questionnaire for parents
Organizational Data
- DRKS-ID:
- DRKS00031444
- Recruitment Status:
- Recruiting planned
- Date of registration in DRKS:
- 2024-02-21
- Last update in DRKS:
- 2024-03-06
- Registration type:
- Prospective
Acronym/abbreviation of the study
FaBI
URL of the study
No Entry
Brief summary in lay language
The purpose of the study is the psychometric validation of the translated German version of the FBI. To date there are no insruments to assess the specific burden of families with a child with congenital Ichthyosis in German language. Linguistically translating and validating existing instruments for this heterogenous disease, provides the short-term opportunity to implement such instruments in clinical settings. Additionally, it facilitates the use in multinational studies.
Brief summary in scientific language
Examination of the psychometric properties of the FBI
Health condition or problem studied
- ICD10:
- Q80.0 - Ichthyosis vulgaris
- Healthy volunteers:
- Yes
Interventions, Observational Groups
- Arm 1:
- one time-point anonymous questionnaire study with parents of patients with congenital Ichthyosis
Endpoints
- Primary outcome:
- psychometric validation of the German "Family Burden in Ichthyosis (FBI)" questionnaire; outcome parameter: factor analysis and validity and reliability tests (e. g. internal consistency and criterion validity)
- Secondary outcome:
- level of psychosocial burden of parents, e. g.: PHQ-9 GAD-7 FDLQI hypotheses: positive association between FaBI-total-score and depressive symptoms (PHQ-9) positive association between FaBI-total-score and anxiety symptoms (GAD-7) positive association between FaBI-total-score and QoL-impairment (FDLQI) positive association between FaBI-total-score and disease severity positive association between FaBI-total-score and maintenance effort positive association between FaBI-total-score and relationship quality (QMI-D) positive association between FaBI-total-score and reduction of working hours reduction of working hours depends on childs age and disease severity compared to fathers a higher proportion of mothers reduces their working hours
Study Design
- Purpose:
- Supportive care
- Retrospective/prospective:
- Retrospective
- Study type:
- Non-interventional
- Longitudinal/cross-sectional:
- Cross-sectional study
- Study type non-interventional:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting planned
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- University medical center Auf der Bult Kinderkrankenhaus Hannover
Recruitment period and number of participants
- Planned study start date:
- 2024-05-02
- Actual study start date:
- No Entry
- Planned study completion date:
- 2024-09-30
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 125
- Final Sample Size:
- No Entry
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- no minimum age
- Maximum Age:
- no maximum age
- Additional Inclusion Criteria:
- child with diagnosis of congenital Ichthyosis
Exclusion Criteria
unsufficient knowledge of German language
Addresses
Primary Sponsor
- Address:
- Kinder- und Jugendkrankenhaus Auf der BultProf. Hagen OttJanusz-Korczak-Allee 1230173 HannoverGermany
- Telephone:
- +49 511 8115-6611
- Fax:
- +49 511 8115-996611
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Medizinische Hochschule HannoverDr. Heike SaßmannCarl-Neuberg-Str. 130625 HannoverGermany
- Telephone:
- +495115324433
- Fax:
- +495115324214
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Contact for Public Queries
- Address:
- Medizinische Hochschule HannoverDr. Heike SaßmannCarl-Neuberg-Str. 130625 HannoverGermany
- Telephone:
- +495115324433
- Fax:
- +495115324214
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Principal Investigator
- Address:
- Medizinische Hochschule HannoverDr. Heike SaßmannCarl-Neuberg-Str. 130625 HannoverGermany
- Telephone:
- +495115324433
- Fax:
- +495115324214
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Sources of Monetary or Material Support
Institutional budget, no external funding (budget of sponsor/PI)
- Address:
- Kinder- und Jugendkrankenhaus Auf der BultJanusz-Korczak-Allee 1230173 HannoverGermany
- Telephone:
- +49 511 8115-6611
- Fax:
- +49 511 8115-996611
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Ethics Committee
Address Ethics Committee
- Address:
- Ethikkommission der Medizinischen Hochschule HannoverCarl-Neuberg-Str. 130625 HannoverGermany
- Telephone:
- +49-511-5323443
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2023-03-09
- Ethics committee number:
- 10835_BO_K_2023
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2023-03-30
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry