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NCT Number: NCT02791321

Fragility Assessment in Adults With ADHD and Mental Retardation

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ADS severity

Other

Evaluation of the ADS severity with the CARS scale

Adaptative and intellectual functioning

Other

Evaluation with IQ and Vineland II scale

Psychiatric and somatic comorbidities

Other

Evaluation with the Reiss, DSQIID and CIRS Scales

Primary outcomes

  1. Frailty index

    Time frame: 1 day

    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

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

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

Acronym: EFAAR

Important dates

Study start
2016
Primary completion
2023
Study completion
2023
First posted
Jun 6, 2016
Registry last updated
Apr 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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