Evaluating the Treatment in the MZEB Aachen | NCT04781452

Studies
Evaluating the Treatment in the MZEB Aachen

NCT04781452

Sponsor

RWTH Aachen University

Status

Recruiting

Last Update Posted

Jun 24, 2024Actual

Enrollment

2,000Estimated

Phase

Not provided

Conditions

Intellectual Disability
Disability Physical

Interventions

standard treatment

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2019Actual

Primary Completion Date

Jul 1, 2029Estimated

Completion Date

Jul 1, 2029Estimated

First Submitted Date

Jan 9, 2020

First Submission Date that Met QC Criteria

Mar 3, 2021

First Posted Date

Mar 4, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 21, 2024

Last Update Posted Date

Jun 24, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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)

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

10 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,000Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
standard treatment	Other	there ist no Intervention but our standart Treatment in the center

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Andrea Maier, MD	Contact	0049 241 8089606		mzeb@ukaachen.de
Robin Steiner	Contact	0049 241 8089606		rsteiner@ukaachen.de

Overall Officials

Name	Affiliation	Role
Jörg B Schulz, MD	RWTH Aachen University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
RWTH Aachen University	Recruiting	Aachen	North Rhine-Westphalia	52074	Germany

Label	URL
Web Address of the institution	View source

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

All relevant results will be shared

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D008607	Intellectual Disability

Ancestor Terms

ID	Term
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases
D012816	Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided