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Cognitive Training for TBI (TeleGOALS Trial)
N/A
Recruiting
Led By Erica S. Kornblith, PhD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Veterans aged 65 or older with history of chronic TBI (>6 months post-injury) sustained either during military service including in combat or as a civilian
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, after 5 week delay repeat baseline, and after 5 week intervention
Awards & highlights
TeleGOALS Trial Summary
This trial will use technology to deliver effective treatment for cognitive problems associated with TBI to Veterans at home.
Who is the study for?
This trial is for aging Veterans, 65 or older, with a history of chronic TBI. They must have cognitive complaints affecting daily life and be comfortable with technology or have someone to assist them. It's not for those with severe cognitive impairment, unstable conditions that hinder participation, drug/alcohol abuse, active psychosis, or poor English comprehension.Check my eligibility
What is being tested?
The study tests GOALS Cognitive Training delivered in two ways: directly in-person and via telehealth at home. The goal is to see if this treatment can improve daily functioning and healthcare access for Veterans with TBI by using technology.See study design
What are the potential side effects?
Since the interventions involve non-medical treatments like cognitive training exercises delivered either in person or through telehealth platforms, there are no direct medical side effects associated with typical drugs or surgical procedures.
TeleGOALS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a veteran over 65 with a long-term brain injury from my service or civilian life.
TeleGOALS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, after 5 week delay repeat baseline, and after 5 week intervention
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, after 5 week delay repeat baseline, and after 5 week intervention
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Mayo-Portland Adaptability Inventory Total Score Change
Overall Attention and Executive Function Change
Profile of Mood States (POMS) Total Mood Disturbance Change
TeleGOALS Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Home-based telehealth GOALSExperimental Treatment1 Intervention
Participants in this arm will receive the GOALS intervention via in-home video telehealth.
Group II: In-person GOALSActive Control1 Intervention
Participants in this arm will receive the GOALS intervention in the traditional in-person format.
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Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,610 Previous Clinical Trials
3,305,148 Total Patients Enrolled
Erica S. Kornblith, PhDPrincipal InvestigatorSan Francisco VA Medical Center, San Francisco, CA
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have significant memory or thinking problems affecting my daily life.I am a veteran over 65 with a long-term brain injury from my service or civilian life.I am not comfortable with technology but have someone who can help me with it for the study.I am unable or unwilling to follow the study procedures.
Research Study Groups:
This trial has the following groups:- Group 1: Home-based telehealth GOALS
- Group 2: In-person GOALS
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.
Are there any current opportunities for individuals to join this research program?
"Affirmative. According to the clinicaltrials.gov website, this trial is actively seeking participants with a first post date of September 9th 2020 and most recent update on January 19th 2022. It requires 36 volunteers at 1 medical centre."
Answered by AI
What is the cap on participation in this clinical trial?
"This is accurate. According to clinicaltrials.gov, the trial was first advertised on September 9th 2020 and has been actively seeking participants ever since; notably, they are looking for 36 people at a single site."
Answered by AI
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