Functional Decline and QoL in People Aging With HIV in Asia

Frailty Clinical Trial

Official title:

Functional Decline and Quality of Life in People Aging With HIV in Asia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04212884
• Other study ID #: Geri_HIV_protocol_v4_26Nov2019
• Status: Recruiting
• Start date: May 1, 2020
• Est. completion date: August 2024

Study information

• Verified date: August 2023
• Source: Chinese University of Hong Kong
• Contact: Catherine Cheung, MPhil
• Phone: +85222528842
• Email: catherinecheung[@]cuhk.edu.hk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a multi-center prospective cross-sectional study to determine the burden of decline in intrinsic capacity and functional ability, and the prevalence of geriatric syndromes, such as frailty, and disability in adult people living with HIV (PLWH) in Asia.

Description:

This research project is expected to have the following clinical impact

1. To understand the impact of impaired functional status in PLWH in Asia would be important to determine the long-term health burden needs in this aging population in this part of the world.

2. The identification of risk factors associated with impaired functional status would be important to guide clinical decisions in patient management, such as the choice of anti-retroviral regimen, and screening of and early intervention for modifiable risk factors. These are of paramount importance in the promotion of healthy aging in this population.

3. This proposed cross-sectional study lays the foundation for the establishment of a longitudinal cohort for long-term follow up of people aging with HIV in Asia, with the objectives of evaluating the long-term impact of aging on clinical outcomes and functional status in PLWH in this region.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years and older

Eligibility

Inclusion Criteria:

• HIV antibody positive

• Age 35 years or above

• Asian ethnicity, including but not limited to Chinese, Malay and Indian

Exclusion Criteria:

• Inability or refusal to consent

• Active infections requiring in-hospital treatment

Related Conditions & MeSH terms

• Disability Physical
• Frailty
• HIV/AIDS

Locations

Country	Name	City	State
Hong Kong	Prince of Wales Hospital	Hong Kong
Hong Kong	Prince of Wales Hospital	Sha Tin

Sponsors (5)

Lead Sponsor	Collaborator
Chinese University of Hong Kong	Chongqing Public Health Medical Center, National Taiwan University, Tan Tock Seng Hospital, University of Malaya

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional disability	Functional disability is defined as any difficulty in any of the six areas of functioning in daily life as assessed by WHO DAS II questionnaire	24 months
Secondary	Composite score for intrinsic capacity	The score is based on (i) self-reported questions assessing the subjects' eight health domains, including mobility, self-care, cognition, interpersonal activities, vision, pain and discomfort, sleep and energy, and affect, and (ii) measures of grip strength, short physical performance battery and cognitive function	24 months
Secondary	Physical performance	Physical performance is measured by six-metre usual gait speed. Low physical performance is defined as usual gait speed =0.8 m/s	24 months
Secondary	Cognitive decline	Cognitive decline is defined as presence of HIV-associated neurocognitive disorder (HAND) according to "Frascati Criteria". Asymptomatic neurocognitive impairment (ANI) involves impairment of cognitive functioning in at least two ability domains, in the absence of interference in everyday functioning. Mild neurocognitive disorder (MND) also involves impairment in at least two ability domains, with at least mild interference in daily functioning. HIV-associated dementia (HAD) requires marked impairment in cognitive functioning in at least two ability domains, in the presence of marked impairment in day-to-day functioning	24 months
Secondary	Frailty	Frailty is measured using the frailty index	24 months
Secondary	Sarcopenia	Sarcopenia is defined as height-adjusted skeletal muscle mass <7.0 kg/m2 in men and 5.7 kg/m2 in women using BIA	24 months
Secondary	Health-related quality of life	Health-related quality of life will be assessed as measured by WHO HIV BREF QOL.	24 months