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

Primary Purpose

Traumatic Brain Injury, Mild Traumatic Brain Injury, Alzheimer's Disease

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Group Wellness Class 1
Group Wellness Class 2
Sponsored by
Kessler Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Traumatic Brain Injury focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kessler FoundationRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group Wellness Class 1

Group Wellness Class 2

Arm Description

Outcomes

Primary Outcome Measures

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
Change on Satisfaction with Life Scale (SWLS)
self-report measure that examines life satisfaction component of subjective well-being and quality of life

Secondary Outcome Measures

Full Information

First Posted
August 26, 2021
Last Updated
December 14, 2022
Sponsor
Kessler Foundation
Collaborators
University of Michigan, Franciscan Health, Rehabilitation Hospital of Indiana, University of California, San Diego
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1. Study Identification

Unique Protocol Identification Number
NCT05048966
Brief Title
Comparison of Two Group Wellness Interventions for Individuals With Neurologic Conditions and Their Support Persons
Official Title
Comparison of Two Group Wellness Interventions for Individuals With Neurologic Conditions and Their Support Persons: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 8, 2022 (Actual)
Primary Completion Date
September 2025 (Anticipated)
Study Completion Date
September 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kessler Foundation
Collaborators
University of Michigan, Franciscan Health, Rehabilitation Hospital of Indiana, University of California, San Diego

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury, Mild Traumatic Brain Injury, Alzheimer's Disease, Brain Injury Traumatic Moderate, Brain Injury Traumatic Severe, Dementia
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
360 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group Wellness Class 1
Arm Type
Experimental
Arm Title
Group Wellness Class 2
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Group Wellness Class 1
Intervention Description
Twelve weekly online group wellness sessions for individuals with the disability and their support person. Each class will last for approximately 2 hours.
Intervention Type
Behavioral
Intervention Name(s)
Group Wellness Class 2
Intervention Description
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 Measure Information:
Title
Change on Self-Efficacy Questionnaire (SEQ)
Description
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
Time Frame
12 weeks (between pre- and post-testing) and 6 months (between post-testing and 6 month follow-up)
Title
Change on Satisfaction with Life Scale (SWLS)
Description
self-report measure that examines life satisfaction component of subjective well-being and quality of life
Time Frame
12 weeks (between pre- and post-testing) and 6 months (between post-testing and 6 month follow-up)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Brionna Robinson, B.S.
Phone
9733248420
Email
brobinson@kesslerfoundation.org
Facility Information:
Facility Name
Kessler Foundation
City
East Hanover
State/Province
New Jersey
ZIP/Postal Code
07936
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthew Weiner
Phone
973-324-3515
Email
mweiner@kesslerfoundation.org

12. IPD Sharing Statement

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

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