Search for Fragility Indicators Among People Aged 50+ With Chronic HIV Infection (Visage 3)

April 6, 2023 updated by: Assistance Publique Hopitaux De Marseille

The frailty and frail elderly was defined in 2001 by Fried as a physiological state of heightened vulnerability to external shocks. 5 criteria for classifying the elderly in 3 categories: frail, pre-frail and not frail. The prevalence of frailty in the general population was estimated to be 7%, 10% and 20% for over 65 years and 45% for over 85 years. This concept is explored in some chronic diseases, in order to prevent the loss of autonomy and tailor the treatment. In the carrier population of HIV, a North American retrospective study showed the frailty syndrome manifested as early as 10 years before, than in the general population. Furthermore various studies show in this specific population, increased incidence of diseases linked to age, suggesting an accelerated and premature aging.

objectives: The objective of this study is to determine the prevalence of frailty defined Fried syndrome in a population of subjects aged 50 and over Holders of chronic HIV infection.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

510

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Marseille, France, 13354
        • Assistance Publique Hôpitaux de Marseille

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient with HIV and followed in the southeastern France area

Exclusion Criteria:

  • In patient HIV infected patient
  • HIV patient disabled (spastic)
  • HIV infected for less than a year

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HIV Patient population over 50 years old
Behavioral: Fried scale for frailty assessement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of frailed patient among the HIV population folloxed in southeastern France area
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique Hopitaux De Marseille

Investigators

  • Study Director: Ureielle DESALBRES, Assistance Publique Hôpitaux de Marseille
  • Study Director: Nathalie PETIT, MD, Assistance Publique Hôpitaux de Marseille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 26, 2012

Primary Completion (Actual)

June 10, 2014

Study Completion (Actual)

April 6, 2023

Study Registration Dates

First Submitted

August 17, 2016

First Submitted That Met QC Criteria

August 17, 2016

First Posted (Estimate)

August 22, 2016

Study Record Updates

Last Update Posted (Actual)

April 7, 2023

Last Update Submitted That Met QC Criteria

April 6, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 2011-41
  • 2011-A01679-32 (Other Identifier: Ansm)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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