- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07486661
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:
- Determine the proportion and characterize the population of PLWH aged 65 and over who screen positive using the Fried scale
- Validate the application of the Fried scale in a population of PLWH
- 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
Conditions
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Agnes Libois, MD
- Phone Number: +3225354130
- Email: maladiesinfectieuses@stpierre-bru.be
Study Contact Backup
- Name: Charlotte Martin, MD, PHD
- Phone Number: +3225354130
- Email: maladiesinfectieusess@stpierre-bru.be
Study Locations
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-
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Brussels, Belgium, 1000
- Recruiting
- CHU Saint-Pierre, centre MIA
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Contact:
- Agnes Libois, MD
- Phone Number: +3225354130
- Email: maladiesinfectieuses@stpierre-bru.be
-
Principal Investigator:
- Agnes Libois, MD
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- living with HIV
- between 65-74 years
Exclusion Criteria:
- none
Study Plan
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
|
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Number of PLWH with Fried scale detecting pre-frailty condition
Time Frame: Baseline
|
Fried scale
|
Baseline
|
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Results of Fried scale at one year
Time Frame: one year after the first Fried scale performed at baseline
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Fried scale performed one year after the first Fried scale in those with a abnormal Fried scale at baseline ( >/=2)
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one year after the first Fried scale performed at baseline
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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.
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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
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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
Publications and helpful links
General Publications
- Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. doi: 10.1093/gerona/56.3.m146.
- Rockwood K,Song X,MacKnight C,Bergman H,Hogan DB,McDowell I,Mitnitski A
- Yamada Y,Kobayashi T,Condo A,Sangarlangkarn A,Ko F,Taniguchi Y,Kojima G
- Jones HT, Levett T, Barber TJ. Frailty in people living with HIV: an update. Curr Opin Infect Dis. 2022 Feb 1;35(1):21-30. doi: 10.1097/QCO.0000000000000798.
- Allavena C, Blain H, Abulizi X, Slama L, Katlama C, Delobel P, Rio V, Cagnot C, Raho-Moussa M, Makinson A, Meyer L. Prevalence and risk factors of frailty among adults living with HIV aged 70 years or older. AIDS. 2023 Jan 1;37(1):183-189. doi: 10.1097/QAD.0000000000003403. Epub 2022 Oct 11.
- Wing EJ. HIV and aging. Int J Infect Dis. 2016 Dec;53:61-68. doi: 10.1016/j.ijid.2016.10.004. Epub 2016 Oct 15.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- B0762025250403
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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