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临床试验/NCT04311554
NCT04311554Unknown不适用

Aging With Dignity, Health, Optimism and Community

Mazonson & Santas Inc.1 个研究点 分布在 1 个国家目标入组 1,049 人开始时间: 2017年10月20日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
1,049
试验地点
1
主要终点
Change in loneliness

研究概览

简要总结

ADHOC is an observational study of people living with HIV over the age of 50. Data from this study will be used to research the interaction between HIV and aging.

详细描述

ADHOC is an observational study that collects data on PLWH over the age of 50 using an online questionnaire. The questionnaire includes information on sociodemographic factors, activities and interests, HIV diagnosis and status, health care use and satisfaction, antiretroviral therapy, comorbid medical conditions, health and well-being, substance use, and sexual practices.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
50 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Change in loneliness

时间窗: Through study completion, an average of 1 year

Measured using the Three-Item Loneliness Scale. This scale is comprised of 3 questions that measure three dimensions of loneliness: relational connectedness, social connectedness and self-perceived isolation.

Loneliness at baseline

时间窗: Baseline

Measured using the Three-Item Loneliness Scale. This scale is comprised of 3 questions that measure three dimensions of loneliness: relational connectedness, social connectedness and self-perceived isolation.

Change in quality of life

时间窗: Through study completion, an average of 1 year

Measured using the PozQoL. PozQoL is a short 13-question scale assessing quality of life among people living with HIV. The scale includes four subscales: health concerns, psychological, social and functional.

Quality of life at baseline

时间窗: Baseline

Measured using the PozQoL. PozQoL is a short 13-question scale assessing quality of life among people living with HIV. The scale includes four subscales: health concerns, psychological, social and functional.

Change in cognitive function

时间窗: Through study completion, an average of 1 year

Measured using the Functional Assessment of HIV Infection (FAHI Cognition). The FAHI Cognition subscale will be used to create a standardized score to assess outcome.

Cognitive function at baseline

时间窗: Baseline

Measured using the Functional Assessment of HIV Infection (FAHI). The FAHI Cognition subscale will be used to create a standardized score to assess outcome.

Change in social well-being

时间窗: Through study completion, an average of 1 year

Measured using the Functional Assessment of HIV Infection (FAHI). The FAHI Social Well-being subscale will be used to create a standardized score to assess outcome.

Social well-being at baseline

时间窗: Baseline

Measured using the Functional Assessment of HIV Infection (FAHI). The FAHI Social Well-being subscale will be used to create a standardized score to assess outcome.

Change in depression

时间窗: Through study completion, an average of 1 year

Measured using the Patient Health Questionnaire - 4 (PHQ-4). PHQ-4 is a brief self-report questionnaire that consists of a 2-item depression scale (PHQ-2) and a 2-item anxiety scale (GAD-2).

Anxiety at baseline

时间窗: Baseline

Measured using the Patient Health Questionnaire - 4 (PHQ-4). PHQ-4 is a brief self-report questionnaire that consists of a 2-item depression scale (PHQ-2) and a 2-item anxiety scale (GAD-2).

Alcohol use at baseline

时间窗: Baseline

Measured using the Alcohol Use Disorder Identification Test (AUDIT-C). The AUDIT-C is a 3-item screening survey that can help identify persons who are hazardous drinkers or have active alcohol use disorders (including alcohol abuse or dependence).

Lipodystrophy at baseline

时间窗: Baseline

Measured using the Assessment of Body Change and Distress (ABCD). The ABCD assesses subjective report of bodily changes and body dissatisfaction, and it includes 20 items on the impact of bodily changes on psychosocial variables, quality of life, and HIV self-care behaviors.

Resilience at baseline

时间窗: Baseline

Measured using the Connor-Davidson Resilience Scale (CD-RISC 2). The CD-RISC contains two items and was developed as a measure of "bounce-back" and adaptability.

Interpersonal support at baseline

时间窗: Baseline

Measured using the Interpersonal Support Evaluation Checklist - 6 (ISEL-6). ISEL-6 is derived from the long form of the ISEL and contains 6 items that assess the perceived availability of social support.

Frailty at baseline

时间窗: Baseline

Measured using the Frailty Index Elders (FIFE). FIFE is a 10-item instrument with scores ranging from 0-10. A score of 0 indicates no frailty; a score of 1-3 indicates frailty risk; and a score of 4 or greater indicates frailty.

Depression at baseline

时间窗: Baseline

Measured using the Patient Health Questionnaire - 4 (PHQ-4). PHQ-4 is a brief self-report questionnaire that consists of a 2-item depression scale (PHQ-2) and a 2-item anxiety scale (GAD-2).

Change in anxiety

时间窗: Through study completion, an average of 1 year

Measured using the Patient Health Questionnaire - 4 (PHQ-4). PHQ-4 is a brief self-report questionnaire that consists of a 2-item depression scale (PHQ-2) and a 2-item anxiety scale (GAD-2).

Change in sleep quality

时间窗: Through study completion, an average of 1 year

Measured using The Medical Outcomes Study Sleep Scale (MOS-SS). MOS-SS includes 12 items assessing sleep disturbance, sleep adequacy, somnolence, quantity of sleep, snoring, and awakening short of breath or with a headache.

Sleep quality at baseline

时间窗: Baseline

Measured using The Medical Outcomes Study Sleep Scale (MOS-SS). MOS-SS includes 12 items assessing sleep disturbance, sleep adequacy, somnolence, quantity of sleep, snoring, and awakening short of breath or with a headache.

Change in alcohol use

时间窗: Through study completion, an average of 1 year

Measured using the Alcohol Use Disorder Identification Test (AUDIT-C). The AUDIT-C is a 3-item screening survey that can help identify persons who are hazardous drinkers or have active alcohol use disorders (including alcohol abuse or dependence).

Change in self-perceived stigma

时间窗: Through study completion, an average of 1 year

Measured using the Internalized AIDS-Related Stigma scale (IAS). IAS is a six-item scale designed to measure the construct of internalized stigma.

Self-perceived stigma at baseline

时间窗: Baseline

Measured using the Internalized AIDS-Related Stigma scale (IAS). IAS is a six-item scale designed to measure the construct of internalized stigma.

Change in lipodystrophy

时间窗: Through study completion, an average of 1 year

Measured using the Assessment of Body Change and Distress (ABCD). The ABCD assesses subjective report of bodily changes and body dissatisfaction, and it includes 20 items on the impact of bodily changes on psychosocial variables, quality of life, and HIV self-care behaviors.

Change in resilience

时间窗: Through study completion, an average of 1 year

Measured using the Connor-Davidson Resilience Scale (CD-RISC 2). The CD-RISC contains two items and was developed as a measure of "bounce-back" and adaptability.

Change in interpersonal support

时间窗: Through study completion, an average of 1 year

Measured using the Interpersonal Support Evaluation Checklist - 6 (ISEL-6). ISEL-6 is derived from the long form of the ISEL and contains 6 items that assess the perceived availability of social support.

Change in anti-HIV medication adherence

时间窗: Through study completion, an average of 1 year

Measured using the brief adherence self-report questionnaire. This questionnaire asks participants how much of their anti-HIV medications they have taken over the past month (0 to 100%).

Anti-HIV medication adherence at baseline

时间窗: Baseline

Measured using the brief adherence self-report questionnaire. This questionnaire asks participants how much of their anti-HIV medications they have taken over the past month (0 to 100%).

Change in frailty

时间窗: Through study completion, an average of 1 year

Measured using the Frailty Index Elders (FIFE). FIFE is a 10-item instrument with scores ranging from 0-10. A score of 0 indicates no frailty; a score of 1-3 indicates frailty risk; and a score of 4 or greater indicates frailty.

次要结局

  • Demographic characteristics(Baseline, and once a year through study completion.)

研究者

发起方
Mazonson & Santas Inc.
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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