Clinical trial NCT03122288: Individualized Cognitive Training in HIV
Official title: Individualized-Targeted Cognitive Training in Older Adults With HAND
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV-Associated Cognitive Motor Complex
Aging
Cognitive Impairment
Cognitive Decline
Attention Impaired
Processing, Visual Spatial
Cognitive Deficit in Attention
Cognitive Disorder in Remission
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2017-04-20
Enrollment: 109
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A pre-post two-group experimental design will be used.
Primary purpose: TREATMENT

Brief 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.

Detailed description: This research directly meets the goals of the NIH Cognitive and Emotional Health Project and the Healthy Brain Initiative which seek to "maintain or improve the cognitive performance of all adults," especially for "populations experiencing the greatest disparities and risks in cognitive health."

Significance: Using the Frascati criteria, 52% - 59% of people with HIV experience some form of HIV-Associated Neurocognitive Disorder (HAND) which affects medication adherence, instrumental activities of daily living (IADLs), and even mood maintenance and quality of life. By 2020, 70% of adults with HIV in the United States will be 50 and older; thus, cognitive aging in this group represents a major concern. In a prior study (R03MH076642-01A2) conducted in the HAART era, when comparing cognitive functioning between older and younger HIV-positive and HIV-negative adults, older adults with HIV performed the worst. In the HAART era, these cognitive impairments continue to be observed in several cognitive domains including memory, learning, executive functioning, and speed of processing.

Regrettably, few behavioral interventions aimed at improving cognition in this pharmacologically-burdened population have been attempted. Pharmacological interventions have short-lived effects, if any, and can produce adverse side effects in a population prone to multiple comorbidities. Fortunately, computerized cognitive training interventions have been shown to improve cognition without adverse side-effects. Yet, only two types of computerized cognitive training interventions have been studied in adults with HIV. Becker and colleagues partially randomized 60 adults with HIV and without HIV to engage in 14 computerized targeted modules (e.g., knowledge, memory) over 24 weeks. No significant effects were found; however, adherence was poor. In a prior study, investigators randomized 46 adults to either a speed of processing training (10 hrs of training) group or a no-contact control group. Adherence was excellent and improvements were observed on this cognitive domain which transferred to an everyday functioning task.

Despite this lack of cognitive training studies in HIV, studies in older adults have shown their efficacy in improving specific cognitive abilities, some as much as 1-1.5 standard deviations (SD) above baseline performance or age/education-based norms. Using Frascati criteria, HAND is diagnosed when a person performs at least 1 to 2 SD below their normative mean on measures of two or more cognitive domains (e.g., verbal memory, speed of processing, executive functioning); yet many individuals may be only a fraction of a SD below the cut off. A meta-analysis of 52 cognitive training studies indicated the average cognitive improvement following cognitive training was 0.22 SD. Although this seems to be a small to moderate effect size, such cognitive training programs can change the diagnosis of HAND for some by improving cognitive performance to within acceptable performance norms. In this study, older adults (50+) with HAND will be enrolled to determine which cognitive domains are attributable to their diagnosis. Then those cognitive domains in which they have impairments will be targeted for training with the corresponding cognitive program. Such a tailored approach to 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 and quality of life. This approach also represents a paradigm shift in changing the way clinicians and researchers look at HAND in that this is not a static "progressive" diagnosis; Antinori et al. observed a 20% fluctuation of HAND over as little as 1 year, with some improving or declining in their cognitive performance. Such fluctuations, at least partially, reflect positive neuroplasticity that can be manipulated with cognitive training to improve cognition which can improve medication adherence and other IADLs. This study will use a basic two group pre-post experimental design of 146 adults with HAND.

Eligibility criteria: Inclusion Criteria:

* Must be 40+ years
* English speaking
* Have HIV-Associated Neurocognitive Disorder (HAND)

Exclusion Criteria:

* Because the study requires several weeks, participants not living in stable housing (e.g., halfway house) will be excluded.
* Participants with significant neuromedical co-morbidities (e.g., schizophrenia, epilepsy, bipolar disorder, multiple sclerosis, Alzheimer's disease or related dementias, mental retardation)
* Currently undergoing radiation or chemotherapy
* A history of brain trauma with a loss of consciousness greater than 30 minutes
* Legally blind or deaf

Primary outcomes:
measure: Prevalence and Severity of HIV-Associated Neurocognitive Disorder (HAND) as Measured by Neurocognitive Tests Interpreted by the Frascati Criteria
timeFrame: Per participants, approximately 10-12 weeks
Secondary outcomes:
measure: Improvement on Everyday Functioning as Measured by the Timed Instrumental Activities of Daily Living Test
timeFrame: Per participants, approximately 10-12 weeks
measure: Improvement on Everyday Functioning as Measured by the Medication Adherence Scale
timeFrame: Per participants, approximately 10-12 weeks
measure: Improvement in Quality of Life as Measured by Depression
timeFrame: Per participants, approximately 10-12 weeks
measure: Improvement in Quality of Life as Measured by Internal Locus of Control
timeFrame: Per participants, approximately 10-12 weeks
measure: Improvement in Quality of Life as Measured by Health-Related Quality of Life
timeFrame: Per participants, approximately 10-12 weeks
measure: Improvement in Quality of Life as Measured by Self-Rated Health
timeFrame: Per participants, approximately 10-12 weeks
measure: Improvement in Quality of Life as Measured by Cognitive Complaints
timeFrame: Per participants, approximately 10-12 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
References:
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citation: Vance DE, Fazeli PL, Moneyham L, Keltner NL, Raper JL. Assessing and treating forgetfulness and cognitive problems in adults with HIV. J Assoc Nurses AIDS Care. 2013 Jan-Feb;24(1 Suppl):S40-60. doi: 10.1016/j.jana.2012.03.006.
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citation: Byun JY, Azuero A, Fazeli PL, Li W, Chapman Lambert C, Del Bene VA, Triebel K, Jacob A, Vance DE. Perceived Improvement and Satisfaction With Training After Individualized-Targeted Computerized Cognitive Training in Adults With HIV-Associated Neurocognitive Disorder Living in Alabama: A Descriptive Cross-sectional Study. J Assoc Nurses AIDS Care. 2022 Sep-Oct 01;33(5):581-586. doi: 10.1097/JNC.0000000000000333. Epub 2022 Apr 1. No abstract available.
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citation: Vance DE, Cody SL, Nicholson WC, Cheatwood J, Morrison S, Fazeli PL. The Association Between Olfactory Function and Cognition in Aging African American and Caucasian Men With HIV: A Pilot Study. J Assoc Nurses AIDS Care. 2019 Sep-Oct;30(5):e144-e155. doi: 10.1097/JNC.0000000000000086.
citation: Vance DE, Lee L, Munoz-Moreno JA, Morrison S, Overton T, Willig A, Fazeli PL. Cognitive Reserve Over the Lifespan: Neurocognitive Implications for Aging With HIV. J Assoc Nurses AIDS Care. 2019 Sep-Oct;30(5):e109-e121. doi: 10.1097/JNC.0000000000000071.
citation: Vance DE, Cody SL, Nicholson C, Cheatwood J, Morrison S, Fazeli PL. Olfactory Dysfunction in Aging African American and Caucasian Men With HIV: A Pilot Study. J Assoc Nurses AIDS Care. 2022 May-Jun 01;33(3):e19-e30. doi: 10.1097/JNC.0000000000000061.
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