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

Part of paid clinical trials in East Hanover, New Jersey.

Sponsor
Kessler Foundation
Study ID
NCT05048966
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Group Wellness Class 1 — 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 — BEHAVIORAL
    Twelve weekly online group wellness sessions for individuals with the disability and their support person. Each class will last for approximately 2 hours.

Study Details

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.

Key Dates

First listed
Sep 17, 2021
Start date
Dec 8, 2022
Status verified
Aug 2026
Primary completion
Sep 30, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
360 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Group Wellness Class 1
  • Active Comparator: Group Wellness Class 2

Primary Outcome Measure

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) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Kessler FoundationEast HanoverNew Jersey07936
Matthew Weiner
[email protected]
973-324-3515

Find similar trials in East Hanover, NJ

Nationwide
Alzheimer's disease trialsNeurology trialsDementia care trialsBrain disorders trialsGeriatrics trials
By condition
Alzheimer's disease
By specialty
NeurologyDementia careBrain disordersGeriatrics
By research site
Kessler Foundation· East Hanover, NJ

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