NCT05048966|RecruitingDMC
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Sponsor study identifier
interventional
360
1 country
1
Study Start
December 8, 2022
Actual (reported)Primary Completion
September 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
September 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Approximately 5.3 million people live with a long-term disability resulting from a traumatic brain injury (TBI) and between 5-8% of those older than 60 suffer from Alzheimer's disease or other forms of dementia (ADRD). Consequences of these conditions can result in dramatic and persistent changes in functioning, impacting not only the patients, but also loved ones who become informal support persons. Many existing services help the family in the moment, but do not address long-term wellness. Thus, the purpose of this research study is to compare the effect of two different types of group wellness treatments for individuals with chronic mild TBI, moderate to severe TBI, and ADRD and their support persons.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 26, 2021
Actual (reported)September 17, 2021
Actual (reported)December 8, 2022
Actual (reported)September 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
September 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Change on Self-Efficacy Questionnaire (SEQ)
self-report instrument that assesses an individual's and support person's self-efficacy as it relates to their ability to manage the effects of the neurologic conditions on their daily functioning
12 weeks (between pre- and post-testing) and 6 months (between post-testing and 6 month follow-up)
Change on Satisfaction with Life Scale (SWLS)
self-report measure that examines life satisfaction component of subjective well-being and quality of life
12 weeks (between pre- and post-testing) and 6 months (between post-testing and 6 month follow-up)
Twelve weekly online group wellness sessions for individuals with the disability and their support person. Each class will last for approximately 2 hours.
Twelve weekly online group wellness sessions for individuals with the disability and their support person. Each class will last for approximately 2 hours.
Kessler Foundation
East Hanover, New Jersey, 07936, United States
First Submitted
August 26, 2021
First Posted
September 17, 2021
Study Start
December 8, 2022
Actual (reported)Primary Completion
September 2027
The Environment's Impact on Thinking When Added to Leg Cycling in People With TBI: VITAL
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
September 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
September 21, 2026
Record last verified: 2026-08
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Source: ClinicalTrials.gov.
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