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

NCT ID: NCT05048966

Last Updated: 2022-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

360 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-08

Study Completion Date

2025-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Traumatic Brain Injury Mild Traumatic Brain Injury Alzheimer's Disease Brain Injury Traumatic Moderate Brain Injury Traumatic Severe Dementia

Keywords

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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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Group Wellness Class 1

Group Type EXPERIMENTAL

Group Wellness Class 1

Intervention Type BEHAVIORAL

Twelve weekly online group wellness sessions for individuals with the disability and their support person. Each class will last for approximately 2 hours.

Group Wellness Class 2

Group Type ACTIVE_COMPARATOR

Group Wellness Class 2

Intervention Type BEHAVIORAL

Twelve weekly online group wellness sessions for individuals with the disability and their support person. Each class will last for approximately 2 hours.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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


* 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


* 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


* 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 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:


* 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)


* 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:


* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Michigan

OTHER

Sponsor Role collaborator

Franciscan Health

UNKNOWN

Sponsor Role collaborator

Rehabilitation Hospital of Indiana

OTHER

Sponsor Role collaborator

University of California, San Diego

OTHER

Sponsor Role collaborator

Kessler Foundation

OTHER

Sponsor Role lead

Responsible Party

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Denise Krch

Senior Research Scientist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Kessler Foundation

East Hanover, New Jersey, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Brionna Robinson, B.S.

Role: CONTACT

Phone: 9733248420

Email: [email protected]

Facility Contacts

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Matthew Weiner

Role: primary

Other Identifiers

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R-1157-21

Identifier Type: -

Identifier Source: org_study_id