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| Name | Class |
|---|---|
| University of Michigan | OTHER |
| Franciscan Health | UNKNOWN |
| Rehabilitation Hospital of Indiana | OTHER |
| University of California, San Diego |
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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.
The study will involve three sites, with a different clinical population targeted at each site. Kessler Foundation will serve as the Coordinating Center and will enroll individuals with moderate/severe TBI. Franciscan Health in Indiana and University of Michigan will serve as partnering sites and will enroll individuals with chronic mild TBI and ADRD respectively. The research protocols at each site will be unique to the patient population, but harmonized through unified project goals: 1) to evaluate the efficacy of two different online group wellness treatments designed to improve self-efficacy and quality of life, and 2) to determine whether patient neurobehavioral functioning moderates the relationship between treatment outcomes and burden in caregivers, and 3) to determine the neural, behavioral, and blood biomarkers that best predict treatment efficacy. It is expected that findings generated from this study will lead to improved holistic approaches for brain injury and dementia systems of care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group Wellness Class 1 | Experimental |
| |
| Group Wellness Class 2 | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Group Wellness Class 1 | Behavioral | Twelve weekly online group wellness sessions for individuals with the disability and their support person. Each class will last for approximately 2 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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For individuals with moderate/severe TBI:
Inclusion Criteria:
Exclusion Criteria:
For individuals with chronic mild TBI:
Inclusion Criteria:
Exclusion Criteria:
For Individuals with Alzheimer's Disease Related Dementias (ADRD)
Inclusion Criteria:
Exclusion Criteria:
For Support Persons:
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Brionna Robinson, B.S. | Contact | 9733248420 | brobinson@kesslerfoundation.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kessler Foundation | Recruiting | East Hanover | New Jersey | 07936 | United States |
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| OTHER |
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| Group Wellness Class 2 | Behavioral | Twelve weekly online group wellness sessions for individuals with the disability and their support person. Each class will last for approximately 2 hours. |
|
| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D001924 | Brain Concussion |
| D000544 | Alzheimer Disease |
| D003704 | Dementia |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D016489 | Head Injuries, Closed |
| D014949 | Wounds, Nonpenetrating |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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