A Pilot Project for PLWH Aged 65-75: Preventing the Development of Frailty (Frailty)

In ageing populations, the main risk is the development of a syndrome of frailty, characterized by the addition of polymorbidity, polymedication, psychosocial difficulties, cognitive disorders, ... This functional decline is linked to a reduction in the person's functional reserves, and will lead to an increase in health problems, hospitalizations and, ultimately, mortality. People living with HIV (PLWH) over 50 develop the same kind of comorbidities as HIV-uninfected people over 75 years-old.

In Belgium, the care of PLWH< 75 years with frailty syndrome is not reimbursed by healthcare insurance, and geriatric assessment and management is therefore not possible in this age group, despite the very real need.

Goals of this project are:

  1. Determine the proportion and characterize the population of PLWH aged 65 and over who screen positive using the Fried scale
  2. Validate the application of the Fried scale in a population of PLWH
  3. Offer a care pathway model to prevent the onset of frailty in people screened as at-risk and who do not benefit from routine screening or care pathway reimbursement.

Projets proposal:

  • Systematic screening of all PLWH aged 65-74 at the MIA Center, by the nurse prior to physician consultation, using the Fried scale.
  • Send all PLWH aged 65-74 who screen positive to Geriatric One Day for an ergo-geriatric consultation to confirm the risk of frailty and set up a preventive care pathway
  • After treatment, perform a patient satisfaction questionnaire + a new Fried scale at one year

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

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

  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

all PLWH followed at the MIA center between 65 and 74 years included

Description

Inclusion Criteria:

  • living with HIV
  • between 65-74 years

Exclusion Criteria:

  • none

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of PLWH between 65 and 74 years with frailty
Time Frame: Baseline

Using Fried scale and complete geriatic assesment The Fried scale is a widely recognized assessment tool designed to evaluate frailty in older adults, particularly those aged 65 and above. It helps identify individuals at increased risk of adverse health outcomes, such as falls, hospitalization, disability, and mortality. The assessment is based on five key criteria: unintentional weight loss, exhaustion, low physical activity, slowness, and weakness, with each positive criterion scoring one point.

Scores of 0 indicate a robust individual, 1-2 suggest a state of pre-frailty, and ≥3 confirm frailty.

Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of PLWH with a Fried test detecting frailty
Time Frame: Baseline
Fried scale
Baseline
Number of PLWH with Fried scale detecting pre-frailty condition
Time Frame: Baseline
Fried scale
Baseline
Results of Fried scale at one year
Time Frame: one year after the first Fried scale performed at baseline
Fried scale performed one year after the first Fried scale in those with a abnormal Fried scale at baseline ( >/=2)
one year after the first Fried scale performed at baseline

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Validate the application of the Fried scale in a population of PLWH
Time Frame: This analyse will be done at the end of the study when all patients will have complete the evaluation at one year.
compared the number of the PLWH with an Fried scale of a score >/= 2 and the number of PLWH with frailty assessed by a complete geriatrician estimation
This analyse will be done at the end of the study when all patients will have complete the evaluation at one year.

Collaborators and Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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)

August 28, 2025

Primary Completion (Estimated)

July 1, 2028

Study Completion (Estimated)

July 1, 2028

Study Registration Dates

First Submitted

January 14, 2026

First Submitted That Met QC Criteria

March 18, 2026

First Posted (Actual)

March 20, 2026

Study Record Updates

Last Update Posted (Actual)

March 20, 2026

Last Update Submitted That Met QC Criteria

March 18, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • B0762025250403

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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.

Subscribe