Individualized Cognitive Training in HIV (TOPS)
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|ClinicalTrials.gov Identifier: NCT03122288|
Recruitment Status : Recruiting
First Posted : April 20, 2017
Last Update Posted : November 16, 2018
|Condition or disease||Intervention/treatment||Phase|
|HIV-Associated Cognitive Motor Complex Aging Cognitive Impairment Cognitive Decline Attention Impaired Processing, Visual Spatial Cognitive Deficit in Attention Cognitive Disorder in Remission||Behavioral: Individualized Cognitive Training Other: No-Contact Control||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||146 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||A pre-post two-group experimental design will be used.|
|Masking:||None (Open Label)|
|Official Title:||Individualized-Targeted Cognitive Training in Older Adults With HAND|
|Actual Study Start Date :||July 27, 2017|
|Estimated Primary Completion Date :||December 30, 2018|
|Estimated Study Completion Date :||April 30, 2019|
Experimental: Individualized Cognitive Training
Participants randomized to this arm will receive 20 hours of computerized cognitive training in the two predominate cognitive domains in which they experience deficits that contribute to their HIV-Associated Neurocognitive Disorder diagnosis.
Behavioral: Individualized Cognitive Training
These are specific computerized exercises that are designed to improve performance in particular cognitive domains (e.g., attention, speed of processing, verbal learning/memory).
Other Name: Insight Software
Participants in this arm will not receive any experimental or sham contact. They will only participate in the Baseline and Posttest assessments.
Other: No-Contact Control
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.
Other Name: Control Group
- Prevalence and Severity of HIV-Associated Neurocognitive Disorder (HAND) as Measured by Neurocognitive Tests Interpreted by the Frascati Criteria [ Time Frame: Per participants, approximately 10-12 weeks ]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. A battery of neurocognitive tests (e.g., Trails Making Test A, Trails Making Test B, etc.) of different domains (e.g., speed of processing, verbal memory, etc.) are used which are normed by age/education which are then use with the Frascati Criteria (a neurological algorithm to classify cognitive impairment) to determine HIV-Associated Neurocognitive Disorder, both presence and severity (i.e., Global Severity Rating). This is administered at baseline and posttest.
- Improvement on Everyday Functioning as Measured by the Timed Instrumental Activities of Daily Living Test [ Time Frame: Per participants, approximately 10-12 weeks ]The Timed Instrumental Activities of Daily Living Test -- This test measures the accuracy and time it takes to perform 5 IADLs (e.g., counting out correct change, reading ingredients on a can of food). Slower speed of processing is associated with longer times to complete these tasks, even after adjusting for age, education level, depression, and general health. The time from each of the 5 IADLs is added together to form a composite score. Test-retest reliability is 0.64. This test is administered at baseline and posttest.
- Improvement on Everyday Functioning as Measured by the Medication Adherence Scale [ Time Frame: Per participants, approximately 10-12 weeks ]Medication Adherence - This IADL is measured by the Simplified Medication Adherence Questionnaire (as well as virological control). It consists of sixl items that ask about how consistently one takes his/her medications; the items can be summed to form a composite score. This measure is validated with virological outcomes and has good internal consistency (α = 0.75) and inter-observer agreement (88.2%). This questionnaire is administered at baseline and posttest.
- Improvement in Quality of Life as Measured by Depression [ Time Frame: Per participants, approximately 10-12 weeks ]Centers for Epidemiological Studies - Depression Scale (CES-D) - This depression scale measures how often (not at all - extremely) participants acknowledge 20 verbal symptoms of depression; score are tallied to form a composite score; higher scores indicate greater self-reported depressive symptomatology. Cronbach's α is very good at 0.88. This scale is administered at baseline and posttest.
- Improvement in Quality of Life as Measured by Internal Locus of Control [ Time Frame: Per participants, approximately 10-12 weeks ]Internal Locus of Control - This six (6-point Likert-type) item measure assesses the degree to which participants perceive that they can exert influence over their life. The items are summed to form a composite score; higher scores indicate more internal locus of control. Cronbach's α's range from 0.62 to 0.79. This measure is administered at baseline and posttest.
- Improvement in Quality of Life as Measured by Health-Related Quality of Life [ Time Frame: Per participants, approximately 10-12 weeks ]Medical Outcomes Study Short Form (SF-36)/Health-Related Quality of Life - SF-36 assesses health-related quality of life which is a subscale of this measure. The item of this subscale are summed to form a composite score. In the ACTIVE Study, improvement on this variable was observed in the speed of processing training group. Cronbach's α is greater than 0.85. This subscale is administered at baseline and posttest.
- Improvement in Quality of Life as Measured by Self-Rated Health [ Time Frame: Per participants, approximately 10-12 weeks ]Medical Outcomes Study Short Form (SF-36)/Self-Rated Health - SF-36 assesses self-rated health on only 1 item which is a Likert type scale (In general, I would say that my health is: Excellent, Very Good, Good, Fair, Poor). In the ACTIVE Study, improvement on self-rated health was observed in the speed of processing training group. This item is administered at baseline and posttest.
- Improvement in Quality of Life as Measured by Cognitive Complaints [ Time Frame: Per participants, approximately 10-12 weeks ]Cognitive Failures Questionnaire (CFQ) - CFQ assesses common everyday cognitive complaints one may have such as in memory (e.g., "Do you forget where you put something like a newspaper or book?"). All of the 25 items on this measure are summed to form an overall composite score; higher scores are indicative of greater subjective cognitive complaints. This questionnaire is administered at baseline and posttest.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03122288
|Contact: David E Vance, PhDfirstname.lastname@example.org|
|United States, Alabama|
|University of Alabama at Birmingham||Recruiting|
|Birmingham, Alabama, United States, 35222|
|Contact: David E Vance, PhD 205-934-7589 email@example.com|
|Contact: Michael Jensen, BS 205-934-6174 firstname.lastname@example.org|