Frailty in Older HIV-infected Individuals | NCT03413683

Studies
Frailty in Older HIV-infected Individuals

NCT03413683

Sponsor

Chinese University of Hong Kong

Status

Recruiting

Last Update Posted

Aug 30, 2023Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

HIV Infections

Interventions

Not provided

Countries

Hong Kong

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2023

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2018Actual

Primary Completion Date

Jan 2028Estimated

Completion Date

Jan 2028Estimated

First Submitted Date

Jan 23, 2018

First Submission Date that Met QC Criteria

Jan 23, 2018

First Posted Date

Jan 29, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 28, 2023

Last Update Posted Date

Aug 30, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Grace Lui, Clinical Assistant Professor, Chinese University of Hong KongPrincipal Investigator

Lead Sponsor

Chinese University of Hong KongOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Frailty has been proposed as a measure of biological (as opposed to chronological) aging. In this study the investigators plan to: (1) measure frailty in a cohort of older HIV-infected individuals in Hong Kong, and its association with mortality and quality of life; (2) identify risk factors predictive of development of frailty in HIV-infected individuals in Hong Kong; and (3) determine the outcomes of HIV-infected individuals in Hong Kong with and without frailty.

The following assessment will be done:

Physical examination including measuring height, weight, hip and waist circumference.
Grip strength, chair stand test, gait speed test, balance tests, and neurocognitive tests
Geriatric syndromes, screening for depression, disability and quality of life.
Blood tests during fasting state to measure metabolic parameters.

This is a prospective longitudinal observational study that lasts for 10 years.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

100Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Frailty	Frailty defined by frailty phenotype measurement, according to Fried (Fried et al., 2011) definition.	10 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

HIV infection with positive anti-HIV antibody
Age ≥50 years

Exclusion Criteria:

Refuses to consent

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

HIV-positive patients who attend Infectious Diseases clinic at Prince of Wales Hospital

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Rity Wong	Contact	+85235053376		ritywong@cuhk.edu.hk
Grace Lui	Contact	+85235051464		gracelui@cuhk.edu.hk

Overall Officials

Name	Affiliation	Role
Grace Lui	CUHK	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Prince of Wales Hospital	Recruiting	Shatin			Hong Kong

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
11253156	Background	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.

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D015229	Sexually Transmitted Diseases, Viral