NCT04781452

Brief 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)

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
37mo left

Started Jul 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress70%
Jul 2019Jul 2029

Study Start

First participant enrolled

July 1, 2019

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 9, 2020

Completed
1.2 years until next milestone

First Posted

Study publicly available on registry

March 4, 2021

Completed
8.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2029

Last Updated

June 24, 2024

Status Verified

June 1, 2024

Enrollment Period

10 years

First QC Date

January 9, 2020

Last Update Submit

June 21, 2024

Conditions

Intellectual DisabilityDisability Physical

Outcome Measures

Primary Outcomes (2)

  • change in number of therapy sessions

    change in the number of therapy sessions per month

    baseline and after one year treatment

  • Change in diagnoses

    Change in percentage of definite diagnoses

    baseline and after one year treatment

Interventions

standard treatmentOTHER

there ist no Intervention but our standart Treatment in the center

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Mixed Population of People with intellectual and severe multiple disability who need this care in this center

You may qualify if:

  • intellectual disability and/or severe multiple disability (disability degree GdB at least 70 and at least one noticeable sign
  • willing to participate

You may not qualify if:

  • housed in an Institution and/or prison

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

RWTH Aachen University

Aachen, North Rhine-Westphalia, 52074, Germany

RECRUITING

Related Links

MeSH Terms

Conditions

Intellectual Disability

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental Disorders

Study Officials

  • Jörg B Schulz, MD

    RWTH Aachen University

    STUDY CHAIR

Central Study Contacts

Andrea Maier, MD

CONTACT

0049 241 8089606mzeb@ukaachen.de

Robin Steiner

CONTACT

0049 241 8089606rsteiner@ukaachen.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 9, 2020

First Posted

March 4, 2021

Study Start

July 1, 2019

Primary Completion (Estimated)

July 1, 2029

Study Completion (Estimated)

July 1, 2029

Last Updated

June 24, 2024

Record last verified: 2024-06

Locations

DE(1)