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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05048966
Recruitment Status : Not yet recruiting
First Posted : September 17, 2021
Last Update Posted : September 17, 2021
Sponsor:
Collaborators:
University of Michigan
Franciscan Health
Rehabilitation Hospital of Indiana
University of California, San Diego
Information provided by (Responsible Party):
Denise Krch, Kessler Foundation

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.

Condition or disease Intervention/treatment Phase
Traumatic Brain Injury Mild Traumatic Brain Injury Alzheimer's Disease Brain Injury Traumatic Moderate Brain Injury Traumatic Severe Dementia Behavioral: Group Wellness Class 1 Behavioral: Group Wellness Class 2 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Two Group Wellness Interventions for Individuals With Neurologic Conditions and Their Support Persons: A Randomized Clinical Trial
Estimated Study Start Date : September 2021
Estimated Primary Completion Date : September 2025
Estimated Study Completion Date : September 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group Wellness Class 1 Behavioral: Group 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.

Active Comparator: Group Wellness Class 2 Behavioral: Group 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.




Primary Outcome Measures :
  1. Change on Self-Efficacy Questionnaire (SEQ) [ Time Frame: 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

  2. Change on Satisfaction with Life Scale (SWLS) [ Time Frame: 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Exclusion Criteria:

  • has had a prior stroke or neurological disease other than mild 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 Alzheimer's Disease Related Dementias (ADRD)

Inclusion Criteria:

  • age 65 and older
  • at least one-year post-diagnosis
  • can read and speak English fluently
  • has a support person who is willing to participate in this study

Exclusion Criteria:

  • has had a prior stroke or neurological disease other than ADRD
  • 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 Support Persons:

Inclusion Criteria:

  • is the support person of an individual with moderate/severe TBI, chronic mild TBI or ADRD who is willing to participate in the study
  • can read and speak English fluently

Exclusion Criteria:

  • has a significant neurological history (e.g. stroke or multiple sclerosis)
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05048966


Contacts
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Contact: Angela Smith 9733248448 asmith@kesslerfoundation.org

Sponsors and Collaborators
Kessler Foundation
University of Michigan
Franciscan Health
Rehabilitation Hospital of Indiana
University of California, San Diego
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Responsible Party: Denise Krch, Senior Research Scientist, Kessler Foundation
ClinicalTrials.gov Identifier: NCT05048966    
Other Study ID Numbers: R-1157-21
First Posted: September 17, 2021    Key Record Dates
Last Update Posted: September 17, 2021
Last Verified: September 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Denise Krch, Kessler Foundation:
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
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Injuries
Brain Injuries, Traumatic
Brain Concussion
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Craniocerebral Trauma
Trauma, Nervous System
Head Injuries, Closed
Wounds, Nonpenetrating