HIV Clinical Trial
— SOPOfficial title:
An RCT of Speed of Processing Training in Middle-Aged and Older Adults With HIV
Verified date | June 2021 |
Source | University of Alabama at Birmingham |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
As people age with HIV, the synergistic effects with normal age-related cognitive declines will accentuate and/or accelerate declines in cognitive functioning which can be detected as early in one's 40s. Although interventions are needed to protect/improve cognitive functioning, one intervention already exists to improve speed of processing. NINR/NIA (January 14, 2014) announced that Speed of Processing Training used in the ACTIVE Study (N = 2,802 community-dwelling older adults) has the ability to enable "older people to maintain their cognitive abilities as they age" even 10 years after training. As shown in the ACTIVE Study, this intervention uniquely improves driving, instrumental activities of daily living (IADL), health-related quality of life, self-rated health, internal locus of control, and protects one from depression; these represent areas of needed intervention for adults with HIV as well. In adults with HIV, previous pilot studies likewise indicate speed of processing declines are associated with poorer driving simulator performance and more self-reported at-fault automobile crashes; such speed of processing declines on driving alone represent a significant public health concern. These studies also demonstrated that Speed of Processing Training improved this cognitive ability and translated into improved performance on a timed measure of IADLs. Based on prior research, this RCT proposal consists of a pre-post two-year longitudinal experimental design whereby 264 adults with HIV, 40+ years and diagnosed with HIV-Associated Neurocognitive Disorder, will be randomly assigned to one of three training conditions: 1) 10 hours of laboratory-based Speed of Processing Training, 2) 20 hours of laboratory-based Speed of Processing Training, or 3) 10 hours of a standardized computer-contact control (sham) condition. AIM 1: Determine whether 10 vs 20 hours of speed of processing training will improve this cognitive ability at post-test, year 1, and year 2 after baseline. AIM 2: Determine whether 10 vs 20 hours of speed of processing training will improve everyday functioning at post-test, year 1, and year 2 after baseline. Exploratory AIM: Determine whether improvement in speed in speed of processing and/or everyday functioning over time mediate improvement quality of life (e.g., depression, health related quality of life).
Status | Completed |
Enrollment | 217 |
Est. completion date | March 11, 2020 |
Est. primary completion date | March 11, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years and older |
Eligibility | Inclusion Criteria: - Since driving-related factors are being examined as one of the outcomes of the intervention, participants must be licensed drivers when entering the study. - Men and/or women - Must be 40+ years - English speaking - Have HIV-Associated Neurocognitive Disorder (HAND) or borderline HAND (defined using Frascati criteria). Exclusion Criteria: - Because this study is longitudinal, participants not living in stable housing (e.g., halfway house) will be excluded. - Potential participants will be excluded if they indicate that they are planning to move outside of the Birmingham metropolitan area within the next 2 years. - Participants with significant neuromedical co-morbidities (e.g., schizophrenia, epilepsy, bipolar disorder, multiple sclerosis, Alzheimer's disease or related dementias, mental retardation) - Legally blind or deaf (vision confirmed at baseline) - Currently undergoing radiation or chemotherapy - A history of brain trauma with a loss of consciousness greater than 30 minutes - Those who have participated in our pilot studies and were randomized to the Speed of Processing Training will be excluded. |
Country | Name | City | State |
---|---|---|---|
United States | University of Alabama at Birmingham | Birmingham | Alabama |
Lead Sponsor | Collaborator |
---|---|
University of Alabama at Birmingham |
United States,
Fazeli PL, Ross LA, Vance DE, Ball K. The relationship between computer experience and computerized cognitive test performance among older adults. J Gerontol B Psychol Sci Soc Sci. 2013 May;68(3):337-46. doi: 10.1093/geronb/gbs071. Epub 2012 Aug 28. — View Citation
Kaur J, Dodson JE, Steadman L, Vance DE. Predictors of improvement following speed of processing training in middle-aged and older adults with HIV: a pilot study. J Neurosci Nurs. 2014 Feb;46(1):23-33. doi: 10.1097/JNN.0000000000000034. — View Citation
Lin F, Chen DG, Vance D, Mapstone M. Trajectories of combined laboratory- and real world-based speed of processing in community-dwelling older adults. J Gerontol B Psychol Sci Soc Sci. 2013 May;68(3):364-73. doi: 10.1093/geronb/gbs075. Epub 2012 Sep 11. — View 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. — View Citation
Vance DE, Fazeli PL, Ross LA, Wadley VG, Ball KK. Speed of processing training with middle-age and older adults with HIV: a pilot study. J Assoc Nurses AIDS Care. 2012 Nov-Dec;23(6):500-10. doi: 10.1016/j.jana.2012.01.005. Epub 2012 May 11. — View Citation
Vance DE. Prevention, Rehabilitation, and Mitigation Strategies of Cognitive Deficits in Aging with HIV: Implications for Practice and Research. ISRN Nurs. 2013;2013:297173. doi: 10.1155/2013/297173. Epub 2013 Feb 3. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Centers for Epidemiological Studies Depression Scale (a quality of life measure) | This is a questionnaire that assesses how much participants identify to 20 verbal symptoms of depression. | Baseline (first visit), Posttest (approximately 10-12 weeks after Baseline), Year 1 (1 year after Baseline), Year 2 (2 years after Baseline) | |
Other | Internal Locus of Control (a quality of life measure) | This is a questionnaire that assesses the degree to which participants can exert influence over one's life. | Baseline (first visit), Posttest (approximately 10-12 weeks after Baseline), Year 1 (1 year after Baseline), Year 2 (2 years after Baseline) | |
Other | Medical Outcomes Study Short Form (a quality of life measure) | This is a questionnaire that assesses the participants' self-rated health and quality of life. | Baseline (first visit), Posttest (approximately 10-12 weeks after Baseline), Year 1 (1 year after Baseline), Year 2 (2 years after Baseline) | |
Other | Cognitive Failures Questionnaire (a quality of life measure) | This is a questionnaire that assesses what type of cognitive cognitive complaints (e.g., Do you forget where you put something like a newspaper or book?") participants experience.. | Baseline (first visit), Posttest (approximately 10-12 weeks after Baseline), Year 1 (1 year after Baseline), Year 2 (2 years after Baseline) | |
Primary | Mean Speed of Processing Measures at baseline | Cognitive measures of speed of processing (i.e., Useful Field of View) will be used to determine whether the training was effective. | at baseline | |
Primary | Mean Speed of Processing Measures at 10 - 12 weeks after baseline | Cognitive measures of speed of processing (i.e., Useful Field of View) will be used to determine whether the training was effective. | at 10-12 weeks after baseline | |
Primary | Mean Speed of Processing Measures at 1 year after baseline | Cognitive measures of speed of processing (i.e., Useful Field of View) will be used to determine whether the training was effective. | at 1 year after baseline | |
Primary | Mean Speed of Processing Measures at 2 years after baseline | Cognitive measures of speed of processing (i.e., Useful Field of View) will be used to determine whether the training was effective. | at 2 years after baseline | |
Secondary | Driving Simulation (a measure of everyday functioning) | This driving simulator generates several outcome variables including number of crashes, number of pedestrians hit, gross reaction time, and other related driving outcomes data. | Baseline (first visit), Posttest (approximately 10-12 weeks after Baseline), Year 1 (1 year after Baseline), Year 2 (2 years after Baseline) | |
Secondary | Number of vehicular crashes identified in State Crash Records for the 5 years prior to enrollment | Driving records for participants will be pull retrospectively for the past 5 years before starting the study, and then prospectively approximately 2.5 years after Baseline (first visit) and approximately 5 years after Baseline (first visit).Documented actual at-fault crashes of the participants will be determined by pulling state driving records from the Alabama Department of Motor Vehicles. | from baseline to 5 years prior to baseline | |
Secondary | Driving Habits Questionnaire (a measure of everyday functioning) | This questionnaire measures self-reported data on the participants' perceived ability to drive. | from baseline to 5 years prior to baseline | |
Secondary | Timed Instrument Activities of Daily Living (a measure of everyday functioning) | This test measures the time required and the accuracy in which 5 instrumental activities of daily living (e.g., counting change) are done. | Baseline (first visit), Posttest (approximately 10-12 weeks after Baseline), Year 1 (1 year after Baseline), Year 2 (2 years after Baseline) | |
Secondary | Medication Adherence (a measure of everyday functioning) | This is a questionnaire that assesses how well participants take their medication as prescribed. | Baseline (first visit), Posttest (approximately 10-12 weeks after Baseline), Year 1 (1 year after Baseline), Year 2 (2 years after Baseline) | |
Secondary | Number of vehicular crashes identified in State Crash Records at 2.5 years after enrollment | Driving records for participants will be pull retrospectively for the past 5 years before starting the study, and then prospectively approximately 2.5 years after Baseline (first visit) and approximately 5 years after Baseline (first visit).Documented actual at-fault crashes of the participants will be determined by pulling state driving records from the Alabama Department of Motor Vehicles. | from baseline to 2.5 years after baseline | |
Secondary | Number of vehicular crashes identified in State Crash Records at 5 years after enrollment | Driving records for participants will be pull retrospectively for the past 5 years before starting the study, and then prospectively approximately 2.5 years after Baseline (first visit) and approximately 5 years after Baseline (first visit).Documented actual at-fault crashes of the participants will be determined by pulling state driving records from the Alabama Department of Motor Vehicles. | from baseline to 5 years after baseline |
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