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Executive Functioning Training for Cognitive Impairment in Aging Adults with HIV (EFT Trial)
Phase 2
Recruiting
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 2 years
Awards & highlights
EFT Trial Summary
This trial will study how cognitive training can reduce HIV-Associated Neurocognitive Disorder (HAND) in older people with HIV, improving functioning & quality of life. It will also identify how to target executive functioning to improve global cognitive ability & reduce cognitive IIV.
Who is the study for?
This trial is for English-speaking adults over 40 with HIV-Associated Neurocognitive Disorder (HAND) who can meet in person and commit to a ~12-week program. It's not for those with major health issues like schizophrenia, significant brain trauma, or recent COVID-19 infection; those undergoing intense treatments like chemo; or individuals living far from the center or in unstable housing.Check my eligibility
What is being tested?
The study tests if Executive Functioning Training over 20 hours improves cognitive abilities in aging adults with HAND compared to no training. Participants are split into two groups: one receives the training and the other doesn't, allowing researchers to see if there's an improvement in cognitive functioning.See study design
What are the potential side effects?
Since this is a non-medical intervention focusing on cognitive training, traditional physical side effects associated with medications are not expected. However, participants may experience fatigue or mental strain due to the intensity of the exercises.
EFT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adherence Rates (after study data collection)
Attrition Rates (after study data collection)
Baseline Assessment of Cognitive Training
+2 moreSecondary outcome measures
BRACE+ (BrainBaseline Assessment of Cognition and Everyday Functioning)
EFT Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Executive Functioning TrainingExperimental Treatment1 Intervention
BrainHQ (POSIT Science Inc.) computerized cognitive training modules will be used as in our other studies; but these will focus on executive functioning training. These programs have gaming components that encourage adherence. BrainHQ cognitive training products are tested and endorsed by the scientific community. A meta-analysis of computerized cognitive training in older adults found optimal therapeutic effects occurred when training sessions last at most 60 minutes and are administered 1-3 times per week - dosage parameters already incorporated in our study. This self-administered program uses touch-screen technology with tablets which allows computer novices to engage with the training exercises.
Group II: No-Contact Control GroupActive Control1 Intervention
These participants will not receive any intervention.
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Who is running the clinical trial?
University of Alabama at BirminghamLead Sponsor
1,590 Previous Clinical Trials
2,281,542 Total Patients Enrolled
16 Trials studying Aging
1,427 Patients Enrolled for Aging
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 40 years old or older.I do not have conditions affecting my thinking or senses, nor am I currently undergoing major treatments.I live more than 60 miles away from the treatment center.I am willing to attend in-person meetings.
Research Study Groups:
This trial has the following groups:- Group 1: Executive Functioning Training
- Group 2: No-Contact Control Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does the FDA approve of Executive Functioning Training as a therapeutic solution?
"Based on its Phase 2 standing, Executive Functioning Training has been evaluated as a 2 in terms of safety. Although there is some evidence to suggest that it can be trusted, no data currently exists to support the efficacy of this intervention."
Answered by AI
Is enrolment currently available for this experiment?
"Affirmative. Clinicaltrials.gov provides evidence that the medical exploration, which was advertised on June 13th of 2021, is currently recruiting participants. 150 individuals are needed across a single location for this research effort."
Answered by AI
What is the ceiling for participants included in this experiment?
"Affirmative. According to clinicaltrials.gov, this medical trial is actively looking for volunteers. It was first published on June 13th 2023 and has since been updated on July 19th 2023; 150 individuals from a single centre are needed as participants in the study."
Answered by AI
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