Alzheimer's Disease, Brain Injury Traumatic Moderate, Brain Injury Traumatic Severe, Dementia, Mild Traumatic Brain Injury, Traumatic Brain Injury
Conditions
Keywords
Traumatic Brain Injury, Mild Traumatic Brain Injury, Alzheimer's Disease, Caregivers, Moderate Traumatic Brain Injury, Severe Traumatic Brain Injury, Alzheimer's disease related dementia, Support Persons
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALGroup Wellness Class 1
Twelve weekly online group wellness sessions for individuals with the disability and their support person. Each class will last for approximately 2 hours.
BEHAVIORALGroup Wellness Class 2
Twelve weekly online group wellness sessions for individuals with the disability and their support person. Each class will last for approximately 2 hours.
Sponsors
University of Michigan
Franciscan Health
Rehabilitation Hospital of Indiana
University of California, San Diego
Kessler Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
For individuals with moderate/severe TBI: Inclusion Criteria: * age 18-64 * at least one year post injury * can read and speak English fluently * has a support person who is willing to participate in the study
Exclusion criteria
* has had a prior stroke or neurological disease other than TBI * has unstable or uncontrolled seizures * has been hospitalized due to a significant psychiatric illness (for example, bipolar disorder, schizophrenia, or psychosis) in the past three months * current alcohol and/or drug use that interferes with ability to carry out common everyday functions For individuals with chronic mild TBI: Inclusion Criteria: * age 18-64 * at least 3 months post-injury * can read and speak English fluently * has a support person who is willing to participate in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change on Self-Efficacy Questionnaire (SEQ) | 12 weeks (between pre- and post-testing) and 6 months (between post-testing and 6 month follow-up) | 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 |
| Change on Satisfaction with Life Scale (SWLS) | 12 weeks (between pre- and post-testing) and 6 months (between post-testing and 6 month follow-up) | self-report measure that examines life satisfaction component of subjective well-being and quality of life |
Countries
United States
Contacts
Primary ContactBrionna Robinson, B.S.
Outcome results
None listed