Feasibility and Usefulness of a Neuropsychological Telerehabilitation Program in Asymptomatic HIV Patients: Pilot Randomized Controlled Trial
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- STATUS
- Recruiting
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- End date
- Jun 30, 2024
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- participants needed
- 24
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- sponsor
- Universidad Nacional Autonoma de Mexico
Summary
Currently 37.9 million people are living with human immunodeficiency virus (HIV) around the world (UNAIDS, 2018). Even with antiretroviral treatment (ART), the virus enters the central nervous system and can affect the following structures: amygdala, hippocampus, thalamus, parietal, frontal, temporal regions, orbitofrontal, cingulate, motor and sensory cortex; generating cognitive, behavioral and motor alterations, up to HIV-associated neurocognitive disorder (HAND) and occasionally HIV-associated dementia (HAD).
Few clinical studies have been conducted using computerized cognitive rehabilitation programs to counteract neuropsychological alterations. The aim of this project is to explore the feasibility of a cognitive stimulation program (CSP) developed to strengthen cognitive domains identified as impaired through a neuropsychological assessment in asymptomatic HIV+ patients adherent to ART, with the purpose of improving their quality of life and mood disorder.
Description
A pilot randomized controlled trial (RCT) will be conducted with a study group and a control group in waiting list. This design will be used because it allows to evaluate the feasibility of a teleneuropsychological intervention (N&C NeuroChange) and to identify a preliminary effect as a first approach in a given population, provides greater experimental control over the study variables and allows pre-intervention, post-intervention and follow-up comparisons.
Lancaster et al. (2004) state that n=30 is acceptable for a pilot study, while (Julious, 2005) suggest a minimum sample of n=12 per group. Therefore, 24 participants will be recruited for this study. This has already been implemented in other pilot studies that sought to identify the efficacy of an intervention using samples of 20 (Berrymam et al., 2020) and 13 participants (Delaney, 2018) in total. Although the size of the sample may be a methodological limitation, it will be considered in the discussion of the results; in addition to being a preliminary study to carry out a more rigorous study with an RCT. Participants will be eligible if they are between 20 and 45 years old because 77.5% of the reported cases are in this age range in Mexico (CENSIDA, 2022) .
The procedure will be as follows: All participants will be explained what the study consists of, the intervention and will be given informed consent. Patients will be recruited from the Specialized Clinic Condesa Iztapalapa that serves people living with HIV. A brief medical history will begin with an interview to collect medical history (HIV pathological and infectious history such as time of evolution, viral load, CD4 level, ART regimen, as well as substance abuse and cognitive complaints) and then a neuropsychological assessment will be performed. With those candidates who meet the inclusion criteria and wish to participate, will be randomly assigned in a 1:1 ratio to the intervention group or waiting list control arm. The intervention will begin first with the study group, and a subsequent evaluation will be carried out and then the intervention will be applied to the control group on the waiting list, which will also undergo a subsequent evaluation. Both groups will undergo a third follow-up evaluation three months later to identify whether the changes were maintained over time. Main outcomes of interest include evaluation of the achievement of intervention objectives, usability and acceptability of the CSP. Baseline and follow up measures include assessment of attention, memory, visuospatial skills, working memory, processing speed, verbal fluency, planning, abstraction, depressive and anxiety symptomatology, and daily functionality.
Details
| Condition | Telerehabilitation, Neuropsychology, HIV Dementia |
|---|---|
| Treatment | Cognitive stimulation program |
| Clinical Study Identifier | NCT05571761 |
| Sponsor | Universidad Nacional Autonoma de Mexico |
| Last Modified on | 28 October 2022 |
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