Ignite Creation Date:
2024-05-06 @ 2:37 PM
Last Modification Date:
2024-10-26 @ 1:34 PM
Study NCT ID:
NCT04371211
Status:
COMPLETED
Last Update Posted:
2020-05-01
First Post:
2019-08-07
Brief Title:
Telemedicine Brain Injury Coping Skills BICS-T Support Group for Brain Injury Survivors and Their Caregivers
Sponsor:
Rehabilitation Hospital of Indiana
Organization:
Rehabilitation Hospital of Indiana
Study Overview
Official Title:
Telemedicine Brain Injury Coping Skills BICS-T Support Group for Brain Injury Survivors and Their Caregivers A Feasibility Study
Status:
COMPLETED
Status Verified Date:
2020-04
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 I
Brief Summary:
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 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
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 functioningThe 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 injuryIn 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
Fourteen participants will be recruited Participants with brain injury or caregivers of brain injury survivors who meet inclusionexclusion criteria will be recruited by the research associate At baseline participants will be asked to come to the Rehabilitation Hospital of Indianas Neuro Rehabilitation Center RHI NRC to collect study equipment and complete baseline data collection First participants will be provided an IPad and training on using the IPad and study software Specifically participants will be trained on turning on the IPad finding the app for the study groups signing into the app and using the app to participate in the group sessions A simulation session will also be provided to ensure participants can login access the software and interact during a session After training participants will be provided take home instructions and contact information for the research assistant for at home troubleshooting if needed Also after training the research assistant will ask participants to provide feedback on the training The research assistant will also ask participants to complete some questionnaires during this visit including a survey including demographics as well as primary and secondary outcome measures The visit is expected to take between one and two hours and this portion of the study will be completed face to face Participants will then be asked to participate in BICS-T BICS-T is a group intervention that will take place over telemedicine software on the IPad provided to participants Sessions will occur once a week for 12 weeks Each session will last two hours This portion of the study is completed 100 on the IPad and will not require any transportation to NRC After BICS-T is over after all 12 sessions 12 weeks participants will be asked to return to RHI NRC to complete post-test surveys and return the equipment that participants receive after participants have completed the program This final session is expected to take approximately two hours
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
Fourteen participants will be recruited Participants with brain injury or caregivers of brain injury survivors who meet inclusionexclusion criteria will be recruited by the research associate At baseline participants will be asked to come to the Rehabilitation Hospital of Indianas Neuro Rehabilitation Center RHI NRC to collect study equipment and complete baseline data collection First participants will be provided an IPad and training on using the IPad and study software Specifically participants will be trained on turning on the IPad finding the app for the study groups signing into the app and using the app to participate in the group sessions A simulation session will also be provided to ensure participants can login access the software and interact during a session After training participants will be provided take home instructions and contact information for the research assistant for at home troubleshooting if needed Also after training the research assistant will ask participants to provide feedback on the training The research assistant will also ask participants to complete some questionnaires during this visit including a survey including demographics as well as primary and secondary outcome measures The visit is expected to take between one and two hours and this portion of the study will be completed face to face Participants will then be asked to participate in BICS-T BICS-T is a group intervention that will take place over telemedicine software on the IPad provided to participants Sessions will occur once a week for 12 weeks Each session will last two hours This portion of the study is completed 100 on the IPad and will not require any transportation to NRC After BICS-T is over after all 12 sessions 12 weeks participants will be asked to return to RHI NRC to complete post-test surveys and return the equipment that participants receive after participants have completed the program This final session is expected to take approximately two hours
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