Viewing Study NCT04386655



Ignite Creation Date: 2024-05-06 @ 2:40 PM
Last Modification Date: 2024-10-26 @ 1:35 PM
Study NCT ID: NCT04386655
Status: COMPLETED
Last Update Posted: 2021-06-11
First Post: 2019-08-08

Brief Title: Brain Injury Coping Skills - Telemedicine Phase II
Sponsor: Devan Parrott
Organization: Rehabilitation Hospital of Indiana

Study Overview

Official Title: Telemedicine Brain Injury Coping Skills BICS-T Support Group for Brain Injury Survivors and Caregivers
Status: COMPLETED
Status Verified Date: 2021-06
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: BICS-T-2
Brief Summary: For phase II the objective is to compare the effectiveness of BICS-T with the well-established BICS in-person group Information gained from phase I the feasibility study was used to make necessary changes to the BICS-T protocol

The purpose of this study is to provide survivors of brain injury and caregivers greater support and teach adaptive coping strategies through a designed and studied a coping skills group specifically for brain injury survivors and their caregivers at the Rehabilitation Hospital of Indiana RHI called the Brain Injury Coping Skills group BICS
Detailed Description: Brain injury can be devastating for both patients and family members and can result in chronic difficulties in vocational social financial as well as physical functioning The occurrence of emotional and neurobehavioral challenges in individuals with brain injury is also common with research consistently showing links between these challenges and a persons overall rehabilitation outcome Additionally family functioning and caregiver well-being has been shown to influence rehabilitation outcome for a survivor after brain injury In fact individuals with families and caregivers who receive support and services as well as learn adaptive coping strategies are less likely to exhibit these marked levels of psychological distress

In order to provide patients and caregivers greater support and teach adaptive coping strategies the authors of this grant designed and studied a coping skills group specifically for brain injury survivors and their caregivers at the Rehabilitation Hospital of Indiana RHI called the Brain Injury Coping Skills group BICS BICS is a 12 session one session per week manualized cognitive-behavioral treatment group designed to provide support coping skills and psychoeducation aimed to improve perceived self-efficacy PSE and emotional functioning Perceived self-efficacy is the belief or confidence in ones ability to deal with the challenges related to a specific situation eg brain injury PSE has been found to be strongly linked to social participation increased positive regard toward the caregiving role and was found to be the greatest contributing factor to predicting life satisfaction Cicerone and Azulay found that the greatest contribution to predicting life satisfaction was the persons PSE for managing their cognitive challenges

Telemedicine is one possible option for rural patients With increases in the availability of internet and electronic communication patients now have immediate access to experts and treatment providers who specialize in brain injury In fact results from a needs assessment from Ricker and colleagues in 2002 identified telemedicine as a desired need of the brain injury community To date several studies have used telemedicine as an avenue to address brain injury rehabilitation for rural patients and caregivers

For phase II the objective is to compare the effectiveness of BICS-T with the well-established BICS in-person group Information gained from phase I the feasibility study was used to make necessary changes to the BICS-T protocol

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None