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Comparison of Two Group Wellness Interventions for Individuals With Neurologic Conditions and Their Support Persons

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Primary and study completion dates: Sep 2025 to Sep 2027
    • Eligibility criteria revised
    • Collaborators revised (4)
    • Study description shortened, about 2 words
    v3
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Sep 2021 to Dec 8, 2022
    • Study sites: 0 to 1
    v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Kessler Foundation
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See 2 trials at risk
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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.
Trial Details
NCT Number NCT05048966
Lead Sponsor Kessler Foundation
Collaborators: University of Michigan, Rehabilitation Hospital of Indiana, University of California, San Diego, Indiana University
Conditions
(from sponsor)		 Traumatic Brain Injury, Mild Traumatic Brain Injury, Alzheimer's Disease, Brain Injury Traumatic Moderate, Brain Injury Traumatic Severe, Dementia
Related terms Alzheimer Disease, Brain Concussion, Brain Injuries, Traumatic, Dementia
Enrollment 360 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov