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临床试验/NCT00619567
NCT00619567已完成1 期

Pilot Study of an Internet-Based Cognitive Stimulation Program in AIDS

University of Pittsburgh1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2007年9月1日最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
已完成
入组人数
60
试验地点
1
主要终点
Global Impairment Rating from battery of neuropsychological tests.

研究概览

简要总结

There has been little success in treating the cognitive (thinking) problems associated with HIV/AIDS using medications. The purpose of this study is to determine whether an internet-based cognitive "stimulation" program might help HIV-infected individuals think more clearly. If this is true, then it means that people with mild forms of cognitive impairment may be able to help themselves to get better.

详细描述

The neurocognitive manifestations of HIV/AIDS have long been recognized as important for the management, survival, and quality of life of affected patients and their families. Following the advent of Highly active anti-retroviral therapy (HAART) the incidence of HIV-associated dementia (HAD) has fallen, but the prevalence of the milder forms of HIV-related cognitive disorders has risen. This is important because alterations in cognitive function can have significant impact on work and social activities, mood, and perceived quality of life. To date, pharmacological management of HIV-associated cognitive disorders - apart from HAART - have met with limited success (e.g., Peptide T, Ritalin). Therefore, it appears reasonable to ask whether the use of non-pharmacological tools might help alleviate or ameliorate the symptoms of the milder forms of cognitive impairment, and thus improve mood and activities of daily living. The purpose of this application is to request funds to allow us to complete a feasibility/pilot study of the merits of using an internet-based cognitive stimulation program (CSP) to improve the cognitive functions and quality of life of individuals with HIV/AIDS, and, secondarily, to detect such changes using a computerized assessment tool designed for use in a health care practitioner's office (Computer-Based Assessment of Mild Cognitive Impairment (CAMCI)).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
40 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Access to the Internet (either from home or public access)
  • •Native language is English
  • •HIV infected
  • •Exclusion Crieria:
  • •Active drug/alcohol abuse or dependence
  • •Current major depression
  • •History of neurological disease, Central Nervous System Opportunistic Infections, tumors, or stroke
  • •History of learning disability or Attention Deficit/Hyperactivity Disorder (by subject report).

排除标准

  • 未提供

研究组 & 干预措施

Cognitive Stimulation

Experimental

Subjects will be given Internet access to the Smartbrain cognitive stimulation program. They will complete exercises for ~30 minutes, at least three times per week, for a period of 24 weeks.

干预措施: Smartbrain (Behavioral)

Control

No Intervention

These individuals will receive "usual care" during the 24 week follow-up period.

结局指标

主要结局

Global Impairment Rating from battery of neuropsychological tests.

时间窗: 24 weeks

次要结局

  • Change in perceived quality of life using MOS/HIV(24 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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