Fragility Assessment in Adults With ADHD and Mental Retardation (EFAAR)
Primary Purpose
Autism Spectrum Disorder, Mental Retardation
Status
Active
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
ADS severity
Adaptative and intellectual functioning
Psychiatric and somatic comorbidities
Sponsored by
About this trial
This is an interventional diagnostic trial for Autism Spectrum Disorder
Eligibility Criteria
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
Sites / Locations
- CHU Montpellier
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Patients with ADS-MR
Arm Description
Patients presenting Autism Spectrum Disorder and mental retardation who are evaluated for their ADS severity, their adaptative and intellectual functioning, psychiatric and somatic comorbidities
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT02791321
First Posted
June 1, 2016
Last Updated
December 27, 2021
Sponsor
University Hospital, Montpellier
1. Study Identification
Unique Protocol Identification Number
NCT02791321
Brief Title
Fragility Assessment in Adults With ADHD and Mental Retardation
Acronym
EFAAR
Official Title
Fragility Assessment in Adults With ADHD and Mental Retardation, Advancing Age
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 23, 2016 (Actual)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
May 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder, Mental Retardation
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
63 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients with ADS-MR
Arm Type
Other
Arm Description
Patients presenting Autism Spectrum Disorder and mental retardation who are evaluated for their ADS severity, their adaptative and intellectual functioning, psychiatric and somatic comorbidities
Intervention Type
Other
Intervention Name(s)
ADS severity
Intervention Description
Evaluation of the ADS severity with the CARS scale
Intervention Type
Other
Intervention Name(s)
Adaptative and intellectual functioning
Intervention Description
Evaluation with IQ and Vineland II scale
Intervention Type
Other
Intervention Name(s)
Psychiatric and somatic comorbidities
Intervention Description
Evaluation with the Reiss, DSQIID and CIRS Scales
Primary Outcome Measure Information:
Title
Frailty index
Description
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
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amaria BAGHDADLI, PU-PH
Organizational Affiliation
CRA Peyre Plantade - La Colombière - CHU Montpellier
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Montpellier
City
Montpellier
ZIP/Postal Code
34000
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Fragility Assessment in Adults With ADHD and Mental Retardation
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