Intellectual DisabilityEvalMZEBNCT04781452
Evaluating the Treatment in the MZEB Aachen
An observational study of Intellectual Disability and Disability Physical, run by RWTH Aachen University at 1 site in Germany.
Trial summary
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) Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Intellectual Disability, Disability Physical
- What is being tested?
- standard treatment
- How many people
- 2,000 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jul 2019to 1 Jul 2029
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Mixed Population of People with intellectual and severe multiple disability who need this care in this center
Who may be able to join
- intellectual disability and/or severe multiple disability (disability degree GdB at least 70 and at least one noticeable sign
- willing to participate
Who cannot join
- housed in an Institution and/or prison
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
RWTH Aachen University
Aachen, North Rhine-Westphalia, 52074
Andrea Maier, MD, 0049241 8089606, mzeb@ukaachen.de
Robin Steiner, 0049241 8089606
About this study
Official title: 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)
Read the 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.
- Conditions
- Intellectual Disability, Disability Physical
- Being tested
- standard treatment
- Medical subject headings
- Intellectual Disability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard treatmentOther
there ist no Intervention but our standart Treatment in the center
What is being measured
The primary outcome is the main question the study is designed to answer.
change in number of therapy sessions
change in the number of therapy sessions per month
Measured: baseline and after one year treatment
Change in diagnoses
Change in percentage of definite diagnoses
Measured: baseline and after one year treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2021
- Study start1 Jul 2019
- Primary completion1 Jul 2029 (estimated)
- Study completion1 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intellectual DisabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Maier, RWTH Aachen University
- Investigators
- Jörg B Schulz, MD, Study chair, RWTH Aachen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04781452
- Sponsor's protocol ID
- 19-006
- Acronym
- EvalMZEB
- Status last verified
- Jun 2024
- First submitted
- 9 Jan 2020
- Last updated
- 24 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: All relevant results will be shared
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Treatment in the the Center for Disabled People in Aachen (MZEB Aachen) - a Registry on Patients With Severe Disabilities
- ClinicalTrials.gov ID
- NCT04781452
- Acronym / sponsor ID
- EvalMZEB / 19-006
- Conditions
- Intellectual Disability, Disability Physical
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 1 Jul 2029 (estimated)
- Study completion
- 1 Jul 2029 (estimated)
- First posted
- 4 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Mixed Population of People with intellectual and severe multiple disability who need this care in this center
Key inclusion criteria (2 listed)
- intellectual disability and/or severe multiple disability (disability degree GdB at least 70 and at least one noticeable sign
- willing to participate
Key exclusion criteria (1 listed)
- housed in an Institution and/or prison
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| standard treatmentthere ist no Intervention but our standart Treatment in the center | Other | – |
Primary outcome
change in number of therapy sessions
Time frame: baseline and after one year treatment
change in the number of therapy sessions per month
Change in diagnoses
Time frame: baseline and after one year treatment
Change in percentage of definite diagnoses
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2024.
- Web Address of the institutionLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. All relevant results will be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jörg B Schulz, MD study chair
RWTH Aachen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intellectual Disability and Disability Physical, run by RWTH Aachen University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrea Maier, MD (0049 241 8089606, mzeb@ukaachen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in number of therapy sessions (time frame: baseline and after one year treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2024; AzTrials last refreshed its copy on 6 Nov 2026.