Quality of Life and care situation in Tuberous Sclerosis
Organizational Data
- DRKS-ID:
- DRKS00016045
- Recruitment Status:
- Recruiting ongoing
- Date of registration in DRKS:
- 2019-03-01
- Last update in DRKS:
- 2019-03-01
- Registration type:
- Retrospective
Acronym/abbreviation of the study
--
URL of the study
No Entry
Brief summary in lay language
Tuberous sclerosis is a genetic disease that affects numerous organ systems and has considerable effects on the person affected and his or her family. So far, only limited information is available on the effects of the disease on the quality of life and living conditions. Knowledge of the quality of life limitations associated with a disease and the costs and impact on the health care system is of immense importance. For the first time in Germany, comprehensive information on the quality of life and care situation of children and adolescents with tuberous sclerosis will be collected. This is done with the help of questionnaires.
Brief summary in scientific language
Tuberous sclerosis (TSC) is a genetic disease that affects numerous organ systems and has significant effects on the person affected and his or her family. So far, only limited information is available on the effects of the disease on the quality of life and living conditions. For the first time in Germany, comprehensive information on the quality of life and care situation of children and adolescents with tuberous sclerosis will be collected. This is done with the help of questionnaires on disease costs, resource consumption, quality of life and depression symptoms.
Health condition or problem studied
- ICD10:
- Q85.1 - Tuberous sclerosis
- ICD10:
- G40 - Epilepsy
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- Patients with TSC (ICD-10 Q85.1) Use of Patient questionnaires
Endpoints
- Primary outcome:
- Cost of illness (Questionnaires for health care resource utilization over 3 to 12 month period)
- Secondary outcome:
- Quality of Life (KINDL, BDI-II (Beck Depression Inventory), Qolie-31 (Quality of Life in Epilepsy))
Study Design
- Purpose:
- No Entry
- Retrospective/prospective:
- No Entry
- Study type:
- Non-interventional
- Longitudinal/cross-sectional:
- No Entry
- Study type non-interventional:
- Epidemiological study
Recruitment
- Recruitment Status:
- Recruiting ongoing
- Reason if recruiting stopped or withdrawn: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 Epilepsiezentrum Frankfurt Rhein-Main Frankfurt a.M.
Recruitment period and number of participants
- Planned study start date:
- No Entry
- Actual study start date:
- 2019-02-28
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 300
- Final Sample Size:
- No Entry
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- no minimum age
- Maximum Age:
- no maximum age
- Additional Inclusion Criteria:
- ICD-10 diagnosis Q85.1
Exclusion Criteria
None
Addresses
Primary Sponsor
- Address:
- Epilepsiezentrum Frankfurt Rhein-MainProf. Dr. Adam StrzelczykSchleusenweg 2-1665208 Frankfurt am MainGermany
- Telephone:
- +49-69-6301-7466
- Fax:
- +49-69-6301-84466
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.kgu.de
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Epilepsiezentrum Frankfurt Rhein-MainProf. Dr. Adam StrzelczykSchleusenweg 2-1665208 Frankfurt am MainGermany
- Telephone:
- +49-69-6301-7466
- Fax:
- +49-69-6301-84466
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.kgu.de
Contact for Public Queries
- Address:
- Epilepsiezentrum Frankfurt Rhein-MainProf. Dr. Adam StrzelczykSchleusenweg 2-1665208 Frankfurt am MainGermany
- Telephone:
- +49-69-6301-7466
- Fax:
- +49-69-6301-84466
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.kgu.de
Principal Investigator
- Address:
- Epilepsiezentrum Frankfurt Rhein-MainProf. Dr. Adam StrzelczykSchleusenweg 2-1665208 Frankfurt am MainGermany
- Telephone:
- +49-69-6301-7466
- Fax:
- +49-69-6301-84466
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.kgu.de
Sources of Monetary or Material Support
Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)
- Address:
- Landes-Offensive zur Entwicklung Wissenschaftlich-ökonomischer Exzellenz (LOEWE) des Hessischen Ministeriums für Wissenschaft und KunstRheinstraße 23-2565185 WiesbadenGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://wissenschaft.hessen.de/wissenschaft/landesprogramm-loewe
Ethics Committee
Address Ethics Committee
- Address:
- Ethikkommission des Fachbereichs Medizin Universitätsklinikum der Goethe-Universität c/o UniversitätsklinikumTheodor-Stern-Kai 7, Haus 1, 2. OG, Zimmer 207-21160590 Frankfurt/MainGermany
- Telephone:
- +49-69-63017239
- Fax:
- +49-69-630183434
- 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:
- 2018-08-15
- Ethics committee number:
- 324/18
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2019-01-08
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 Entry
- 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