- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04781452
Evaluating the Treatment in the MZEB Aachen (EvalMZEB)
December 29, 2022 updated by: Andrea Maier, RWTH Aachen University
Evaluating the Treatment in the the Center for Disabled People in Aachen (MZEB Aachen) - a Registry on Patients With Severe Disabilities
Evaluation of patient characteristics, involved physicians and therapists as well as therapies in a German University Center for the Treatment of patients with intellectual disabilities and severe multiple disability (MZEB Aachen)
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
In the MZEB Aachen, since 11/2018 patients with intellectual disabilities and/or severe multiple disabilities are diagnosed, treated and accompanied for many years in a multidisciplinary setting with physicians, nurses, physiotherapists, ergo therapists, speech therapists and Support by social workers.
MZEBs are considered to have a pilot function in the health care system, cooperating with therapists and physicians in the surroundings.
This concept is established as a new concept in Germany in order to optimise health care for patients with disabilities.
Thus we want to investigate patient characteristics, diagnoses, involved physicians and therapists as well as proposed therapies and disease progress in this center.
Study Type
Observational
Enrollment (Anticipated)
2000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Andrea Maier, MD
- Phone Number: 0049 241 8089606
- Email: mzeb@ukaachen.de
Study Contact Backup
- Name: Robin Steiner
- Phone Number: 0049 241 8089606
- Email: rsteiner@ukaachen.de
Study Locations
-
-
Nordrhein Westfalen
-
Aachen, Nordrhein Westfalen, Germany, 52074
- Recruiting
- RWTH Aachen University
-
Contact:
- Andrea Maier, MD
- Phone Number: 0049241 8089606
- Email: mzeb@ukaachen.de
-
Contact:
- Robin Steiner
- Phone Number: 0049241 8089606
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Mixed Population of People with intellectual and severe multiple disability who need this care in this center
Description
Inclusion Criteria:
- intellectual disability and/or severe multiple disability (disability degree GdB at least 70 and at least one noticeable sign
- willing to participate
Exclusion Criteria:
- housed in an Institution and/or prison
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
change in number of therapy sessions
Time Frame: baseline and after one year treatment
|
change in the number of therapy sessions per month
|
baseline and after one year treatment
|
Change in diagnoses
Time Frame: baseline and after one year treatment
|
Change in percentage of definite diagnoses
|
baseline and after one year treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Jörg B Schulz, MD, RWTH Aachen University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2019
Primary Completion (Actual)
July 1, 2021
Study Completion (Anticipated)
July 1, 2029
Study Registration Dates
First Submitted
January 9, 2020
First Submitted That Met QC Criteria
March 3, 2021
First Posted (Actual)
March 4, 2021
Study Record Updates
Last Update Posted (Actual)
December 30, 2022
Last Update Submitted That Met QC Criteria
December 29, 2022
Last Verified
December 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19-006
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
IPD Plan Description
All relevant results will be shared
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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