CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 109 enrolled
Drug / intervention
Individualized Cognitive Training +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03122288
NCT03122288N/ACompleted

Individualized-Targeted Cognitive Training in Older Adults With HAND

University of Alabama at Birmingham·interventional·Posted Apr 20, 2017·Updated Oct 19, 2021

In Brief

A clinical study evaluating Individualized Cognitive Training and No-Contact Control for HIV-Associated Cognitive Motor Complex and 7 related conditions. Completed, enrolled 109 participants across 1 site.

Detailed Summary

Over 50% of adults with HIV have some form of HIV-Associated Neurocognitive Disorder (HAND) which represents a significant symptom that interferes with everyday functioning and quality of life. As adults age with HIV, they are more likely to develop comorbidities such as cardiovascular disease, hypertension, and insulin resistance which will further contribute to poorer cognitive functioning and HAND. Based upon the Frascati criteria, HAND is diagnosed when a person performs less than 1 to 2 SD below their normative mean (education \& age) on measures of two or more cognitive domains (e.g., attention, speed of processing, verbal memory, executive functioning). Yet, from the cognitive literature and prior studies, administering certain computerized cognitive training programs may improve specific cognitive domains in older adults and those with HIV. Such cognitive training programs may be effective in older adults with HIV and therefore investigators may be able to change the diagnosis of HAND in such cognitively vulnerable adults. In this pre-post experimental study, 146 older adults (50+) with HAND will be randomized to be in either: 1) the Individualied-Targeted Cognitive Training, or 2) a no-contact control group. The investigators will focus on those cognitive domains in which participants express an impairment and train them with the corresponding cognitive program. Such an Individualized-Targeted Cognitive Training approach using standard cognitive training programs may offer hope and symptom relief to those individuals diagnosed with HAND. Furthermore, these changes may result in improved everyday functioning (e.g., IADLs) and quality of life. This approach represents a paradigm shift in possibly changing the way HAND is examined. Specific Aim 1: Compare adults who do receive Individualized-Targeted Cognitive Training to those who do not in order to determine whether a change in HAND prevalence and severity occurs between groups. Exploratory Aim 1: Compare adults who do receive individualized-targeted cognitive training to those who do not in order to determine whether this improves everyday functioning (e.g., IADLs). Exploratory Aim 2: Determine whether improvements in HAND and/or everyday functioning over time mediate improvements in quality of life.

Study Details

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedApr 20, 2017
Enrollment StartJul 27, 2017
Primary CompletionFeb 27, 2019
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 9.2 years ago

Interventions

Individualized Cognitive Trainingbehavioral

These are specific computerized exercises that are designed to improve performance in particular cognitive domains (e.g., attention, speed of processing, verbal learning/memory).

No-Contact Controlother

This is simply a no-contact control group. Participants in this group will receive no additional contact with the study beyond the baseline and posttest assessments.