CompletedNot Applicable

GOALS Cognitive Training Delivered to Aging Veterans in Person or Via Telehealth

United States29 participantsStarted 2020-09-09

Plain-language summary

This study will use technology to deliver effective treatment for cognitive problems associated with TBI to Veterans at home, which may result in improved daily functioning and increased access to health care for the growing population of aging Veterans with history of TBI. The successful completion of this project may also increase older Veterans' ability to participate in research through increased understanding of the effect of in-home research opportunities on recruitment and retention. Additionally, the evidence gathered from this study may be used in future research studying home-based cognitive rehabilitation treatments for Veterans using telehealth technology.

Who can participate

Age range

65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 * Self-reported cognitive complaints \[1 moderate or severe cognitive symptom(s) on the Neurobehavioral Symptom Inventory (NSI \[58\]) that interfere(s) with daily function\] * Endorsement of comfort and familiarity with technology and/or the possession of a personal computer, or other HBT-compatible device * i.e., tablet, or smartphone * Per the investigators' preliminary patient survey, approximately 75% of the target population has access to a personal computer * Participants who do not endorse comfort/familiarity with technology may be eligible to participate if they can identify a family member or other caregiver who is consistently present and willing to assist with connecting to study sessions * A limited number of VA-issued tablets will be available for use by participants who do not have access to a personal computer or other HBT-compatible device Exclusion Criteria: Moderate-severe objective cognitive impairment, as measured by score \<20 on the Montreal Cognitive Assessment (MoCA \[59-61\]), that interferes with daily functioning (i.e., Major Neurocognitive Disorder) * Unstable medical, neurologic, or psychiatric conditions precluding participation in research activities * Other reasons for being unable or unwilling to participate in study procedures * Ongoing illicit…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Overall Attention and Executive Function Change

Timeframe: Baseline, after 5 week delay repeat baseline, and after 5 week intervention

Profile of Mood States (POMS) Total Mood Disturbance Change

Timeframe: Baseline, after 5 week delay repeat baseline, and after 5 week intervention

Mayo-Portland Adaptability Inventory Total Score Change

Timeframe: Baseline, after 5 week delay repeat baseline, and after 5 week intervention

Trial details

NCT IDNCT04111549

SponsorVA Office of Research and Development

Sponsor typeFED

Study typeINTERVENTIONAL

Primary completion2025-09-30

View on ClinicalTrials.gov More Brain Injuries, Traumatic trials

Plain-language summary

Who can participate

Age range

65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Overall Attention and Executive Function Change

Timeframe: Baseline, after 5 week delay repeat baseline, and after 5 week intervention

Profile of Mood States (POMS) Total Mood Disturbance Change

Timeframe: Baseline, after 5 week delay repeat baseline, and after 5 week intervention

Mayo-Portland Adaptability Inventory Total Score Change

Timeframe: Baseline, after 5 week delay repeat baseline, and after 5 week intervention