Fragility Assessment in Adults With ADHD and Mental Retardation (EFAAR)
Fragility Assessment in Adults With ADHD and Mental Retardation, Advancing Age
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.
Study Overview
Status
Conditions
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Montpellier, France, 34000
- CHU Montpellier
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Other: Patients with ADS-MR
Patients presenting Autism Spectrum Disorder and mental retardation who are evaluated for their ADS severity, their adaptative and intellectual functioning, psychiatric and somatic comorbidities
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Evaluation of the ADS severity with the CARS scale
Evaluation with IQ and Vineland II scale
Evaluation with the Reiss, DSQIID and CIRS Scales
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Frailty index
Time Frame: 1 day
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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
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1 day
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Amaria BAGHDADLI, PU-PH, CRA Peyre Plantade - La Colombière - CHU Montpellier
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 9691
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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