Fragility Assessment in Adults With ADHD and Mental Retardation
NCT ID: NCT02791321
Last Updated: 2024-04-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
63 participants
INTERVENTIONAL
2016-09-23
2023-05-16
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Aging Stereotypes and Prodromal Alzheimer's Disease
NCT03138018
Assessing Frailty in Older Adults With Functional Mental Illness
NCT03018951
Screening of the Frailty Degree in the Emergency Department Short Stay Unit
NCT04812834
Multidomain Intervention to Prevent Disability in Elders
NCT02082171
Screening of Psycho-cognitive Troubles in Elderly Patients
NCT00831805
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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
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
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* Pregnant woman or nursong mother
* Patient with Down syndrom
20 Years
95 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University Hospital, Montpellier
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Amaria BAGHDADLI, PU-PH
Role: PRINCIPAL_INVESTIGATOR
CRA Peyre Plantade - La Colombière - CHU Montpellier
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
CHU Montpellier
Montpellier, , France
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
9691
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.