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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01695395
Other study ID # BMBF-01GY1134
Secondary ID
Status Completed
Phase N/A
First received September 26, 2012
Last updated February 10, 2015
Start date February 2012
Est. completion date July 2014

Study information

Verified date February 2015
Source Technische Universität Dresden
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Ministry of Education and Research
Study type Observational

Clinical Trial Summary

Quality of mental health services provision for adults with intellectual disability and comorbid mental disorder is considered inadequate and therefore in need of further improvement. However, empirical findings on this topic are rather scarce. The MEMENTA-study therefore aims to compare mild and moderate intellectual disabled adults with a comorbid mental disorder to mild and moderate intellectual disabled adults who do not have a comorbid mental disorder with respect to clinical parameters. The MEMENTA-study is an observational, epidemiological, cross-sectional study. A representative sample of the target population is realised by the assessment of approximately n=600 intellectual disabled adults working at specialized facilities (sheltered workshops). A cluster sampling with probability proportional to institution and size (n of overall employed persons) will be followed by a simple random sampling of persons of these clustered facilities. A number of parameters such as severity of mental health impairment, needs for care, quality of life (QoL), caregiver burden, health services utilization, and costs for care will be assessed by using a set of well-established standardised instruments. Quality of mental health care will be assessed and examined by open questions to intellectual disabled adults with a comorbid mental disorder as well as informal caregivers and staff of caring institutions.


Recruitment information / eligibility

Status Completed
Enrollment 371
Est. completion date July 2014
Est. primary completion date April 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- mild or moderate intellectual disability

- adults aged between 18-65 years

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional


Locations

Country Name City State
Germany Psychiatric Health Service Research Group, Department of Psychiatry and Psychotherapy, Carl Gustav Carus University Hospital Dresden Saxony
Germany Central Institute of Mental Health Mannheim
Germany Mental Health Services RU, Department of Psychiatry II, Ulm University Ulm

Sponsors (2)

Lead Sponsor Collaborator
Technische Universität Dresden German Federal Ministry of Education and Research

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mental Health status baseline No
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