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

December 14, 2022 updated by: Denise Krch, Kessler Foundation

Comparison of Two Group Wellness Interventions for Individuals With Neurologic Conditions and Their Support Persons: A Randomized Clinical Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
360

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • New Jersey
      • East Hanover, New Jersey, United States, 07936
        • Recruiting
        • Kessler Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
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)
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
12 weeks (between pre- and post-testing) and 6 months (between post-testing and 6 month follow-up)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kessler Foundation

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of California, San Diego
University of Michigan
Rehabilitation Hospital of Indiana
Franciscan Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 8, 2022

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2025

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 26, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 16, 2021

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 17, 2021

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 16, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 14, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • R-1157-21

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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