Fragility Assessment in Adults With ADHD and Mental Retardation

Autism Spectrum Disorder Clinical Trial

— EFAAR  

Official title:

Fragility Assessment in Adults With ADHD and Mental Retardation, Advancing Age

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02791321
• Other study ID #: 9691
• Status: Completed
• Phase: N/A
• Start date: September 23, 2016
• Est. completion date: May 16, 2023

Study information

• Verified date: April 2024
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Frailty is a age dependent physiological state of vulnerability. Frailty is screened by the phenotypic model (5 clinical criteria) or the cumulative model (various clinical and biological criteria). Currently, aging with autism spectrum disorder and mental retardation (ADS-MR) is poor described. Nevertheless many data indicate that people with ADS-MR may present an early aging.

Principal aim of this study is to determine if frailty in people with ADS-MR aged over 20 years depend on age. Secondary aims are to evaluate frailty prevalence, to describe with details health according to age, and to verify the frailty index validity for predicting falls, hospitalisation and death, in this population of ADS-MR patients aged over 20 years.

This monocentric and prospective study will include 60 ADS-MR patients aged over 20 years and living in Languedoc-Roussillon's medico-social care homes. Patients are evaluated at the time of inclusion. Frailty index is calculated from 104 clinical and biological criteria. Furthermore the investigator staff collect data about ADS severity (CARS), adaptative and intellectual functionning (Vineland), and psychiatric and somatic comorbidities (Reiss scale, DSQIID and CIRS). Falls, hospitalisations or death occurrence is then collected every year during 5 years.

The connection between frailty index and age will be studied using linear regression. The frailty index validity will be analysed using ROC curves. Modelisation of the falls, hospitalisations or death risk in the 5 years after the initial evaluation will help in identification of the more frailty predictive criteria.

Description:

Calendar :

This study will take place during 60 months. 4 first months will be devoted at the ethic and administrative issues. Inclusion will take place during 26 months. Follow-up will take 5 years. Last months will be used for data analysis and articles submission.

Perspectives :

This study will be the first describing frailty evolution during aging in patients suffering from ADS-MR. It will be useful for creating a new, simple and pragmatical frailty screening tool specific for ADS-MR patients in order to detect earlier which patient are the most frail.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: May 16, 2023
• Est. primary completion date: May 16, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 95 Years

Eligibility

Inclusion Criteria:

• ADS diagnosis using DSM-5 or CIM-10 criteria, associated to mental retardation

• Age over 20 years

• Patient living in Languedoc-Roussillon's medico-social care home

• Patient benefiting from social security

• Patient or legal representative consent collected

Exclusion criteria:

• Patient or legal representative disagreement to participate at the sudy

• Pregnant woman or nursong mother

• Patient with Down syndrom

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Intellectual Disability
• Mental Retardation

Intervention

Other:
• ADS severity
Evaluation of the ADS severity with the CARS scale
• Adaptative and intellectual functioning
Evaluation with IQ and Vineland II scale
• Psychiatric and somatic comorbidities
Evaluation with the Reiss, DSQIID and CIRS Scales

Locations

Country	Name	City	State
France	CHU Montpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frailty index	this correspond to the frailty cumulative model : 104 clinical and biological criteria are collected. IF = patient criteria (quoted +1 or 0) sum / evaluated criteria total sum	1 day