Brain Injury Coping Skills - Telemedicine: Phase II (BICS-T-2)
Primary Purpose
Traumatic Brain Injury, Coping Skills, Caregivers
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Brain Injur Coping Skills - Telemedicine
Sponsored by
About this trial
This is an interventional treatment trial for Traumatic Brain Injury
Eligibility Criteria
Inclusion Criteria:
- Participants enrolled in the study will be (1) persons with a history of brain injury (e.g., Traumatic Brain Injury; TBI) or acquired BI (e.g., stroke, hypoxia, ruptured aneurysm, or metabolic encephalopathy) OR a caregiver of a brain injury survivor; (2) 18 years of age and older; and (3) at least six months post-injury. Since there is no reason to believe that treatment effectiveness varies with chronicity, no maximum has been set for time post-injury.
Exclusion Criteria:
- Participants will not be included in the study if they present with the following: (1) at imminent risk of psychiatric breakdown, or in imminent danger of hurting themselves or others; (2) active psychosis; (3) aphasia that limits group participation; or (4) significant neurobehavioral difficulties that would be deemed disruptive to group participation.
Sites / Locations
- Rehabilitation Hospital of Indiana
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Telemedicine Group
In-Person Group
Arm Description
BICS-T is the intervention that will take place over telemedicine software on the iPad provided to participants
Participants a part of the in-person BICS group will then come to the NRC for the following BICS sessions. This group is the traditional, in-person, BICS group
Outcomes
Primary Outcome Measures
Brain Injury Self-Efficacy Scale (BICS-Q)
This measure assesses perceived self-efficacy regarding a person's brain injury. Participants respond to each item using a scale from 0 (Not at all) to 4 (Extremely). Items are totaled and higher scores suggest greater perceived self-efficacy.
Secondary Outcome Measures
The Group Climate Questionnaire (GCQ)
the most commonly used group process instrument. It is a self-report, 12-item questionnaire that assesses the person's perceptions of the group's therapeutic environment. Items are scored on a 7-point Likert scale ranging from "Not at all" to "Extremely." The three subscales includes Engagement (the level of positive working group atmosphere), Conflict (the level of anger and tension in the group), and Avoidance (the level of behaviors indicating avoidance of personal responsibility of group work by the members).
Group Session Rating Scale (GSRS)
This is a 4-item questionnaire that assesses a person's feelings and perceptions towards the group content and relationships. Items are measured on an analog scale, ranging from 1-10. The four items measure four different aspects of the group environment including: Relationship, Goals, Acceptability, and Overall Fit.
Patient-reported outcome measurement information system (PROMIS): General Self-Efficacy
This measures a person's confidence in managing daily activities, emotions, medications/treatments, social interactions, and symptoms. Participants respond to each item using a scale from 1 (I am not at all confident) to 5 (I am very confident). Higher scores suggest higher perceived self-efficacy.
Quality of Life After Brain Injury (TBIQOL)
This is a quality of life measure designed specifically for patients with brain injury. Participants respond to how satisfied they feel about each item using the following scale: 1 (Not at all), 2 (Slightly), 3 (Moderately), 4 (Quite), 5 (Very). Item scores are added and higher scores suggest higher perceived quality of life after brain injury.
Patient-reported outcome measurement information system (PROMIS): Health-Related Quality of Life (HRQL) Physical Function
This is a part of an evaluation on a person's overall quality of life based on physical limitations and ability to participate socially. Participants rate each statement from 1 (unable to do) to 5 (without any difficulty). Higher scores suggest greater physical functioning ability.
Patient-reported outcome measurement information system (PROMIS): Health-Related Quality of Life (HRQL) Anxiety scale
This is a part of an evaluation on a person's overall quality of life based on physical limitations and ability to participate socially. Participants rate each statement from 1 (Never) to 5 (Always). Higher scores suggest greater anxiety.
Patient-reported outcome measurement information system (PROMIS): Health-Related Quality of Life (HRQL) Depression scale
This is a part of an evaluation on a person's overall quality of life based on physical limitations and ability to participate socially. Participants rate each statement from 1 (Never) to 5 (Always). Higher scores suggest greater depressive symptoms.
Patient-reported outcome measurement information system (PROMIS): Health-Related Quality of Life (HRQL) Fatigue scale
This is a part of an evaluation on a person's overall quality of life based on physical limitations and ability to participate socially. Participants rate each statement from 1 (Not at all) to 5 (Very much). Higher scores suggest greater fatigue.
Patient-reported outcome measurement information system (PROMIS): Health-Related Quality of Life (HRQL) Sleep Disturbance scale
This is a part of an evaluation on a person's overall quality of life based on physical limitations and ability to participate socially. Participants rate each statement from 1 (Not at all) to 5 (Very much). Higher scores suggest greater sleep disturbance (worse sleep).
Patient-reported outcome measurement information system (PROMIS): Health-Related Quality of Life (HRQL) Ability to Participate in Social Roles and Activities scale
This is a part of an evaluation on a person's overall quality of life based on physical limitations and ability to participate socially. Participants rate each statement from 1 (Always) to 5 (Never). Higher scores suggest greater ability to participate in social roles and activities.
Patient-reported outcome measurement information system (PROMIS): Health-Related Quality of Life (HRQL) Pain Interference scale
This is a part of an evaluation on a person's overall quality of life based on physical limitations and ability to participate socially. Participants rate each statement from 1 (Not at all) to 5 (Very much). Higher scores suggest greater likelihood that pain is interfering with the participant's every functioning.
Patient-reported outcome measurement information system (PROMIS): Health-Related Quality of Life (HRQL) Pain Intensity scale
This is a part of an evaluation on a person's overall quality of life based on physical limitations and ability to participate socially. Participants rate their pain on a 0 to 10 scale (0 = no pain, 10 = worse pain imaginable).
Therapeutic Factors Inventory (TFI)
This a 7-point Likert scale for group settings. It measures one's feeling of acceptance in a group setting, as well as sense of belonging, working together, trust, and caring. The scale ranges from 1 (Strongly Disagree) to 7 (Strongly Agree). Higher scores suggest greater positivity about group acceptance, trust, caring, and working together.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04386655
Brief Title
Brain Injury Coping Skills - Telemedicine: Phase II
Acronym
BICS-T-2
Official Title
Telemedicine Brain Injury Coping Skills (BICS-T) Support Group for Brain Injury Survivors and Caregivers
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
March 28, 2019 (Actual)
Primary Completion Date
August 1, 2020 (Actual)
Study Completion Date
August 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Devan Parrott
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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 person's 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 one's ability to deal with the challenges related to a specific situation (e.g., 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 person's 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury, Coping Skills, Caregivers
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Control Trial Approximately 50 survivors with brain injury who meet inclusion/exclusion criteria and their caregivers will be recruited. There will be 3 waves within one year. Each wave will be split into 2 groups. Half of the participants in each wave will attend a regular BICS program (in-person), while the other half will participate in a BICS-T program.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
49 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Telemedicine Group
Arm Type
Experimental
Arm Description
BICS-T is the intervention that will take place over telemedicine software on the iPad provided to participants
Arm Title
In-Person Group
Arm Type
Active Comparator
Arm Description
Participants a part of the in-person BICS group will then come to the NRC for the following BICS sessions. This group is the traditional, in-person, BICS group
Intervention Type
Behavioral
Intervention Name(s)
Brain Injur Coping Skills - Telemedicine
Intervention Description
BICS sessions (both in-person and telemedicine) will occur once a week for 12 weeks. Each session will last two hours.
Modules of BICS include: Introduction to Brain Injury, Expectations for Recovery, Tips on Managing Challenging Problems, Learning about Depression after the Brain Injury, The 4 R's of Stress Management, Communicating Effectively with Professionals
Primary Outcome Measure Information:
Title
Brain Injury Self-Efficacy Scale (BICS-Q)
Description
This measure assesses perceived self-efficacy regarding a person's brain injury. Participants respond to each item using a scale from 0 (Not at all) to 4 (Extremely). Items are totaled and higher scores suggest greater perceived self-efficacy.
Time Frame
Through study completion, up to 5 months
Secondary Outcome Measure Information:
Title
The Group Climate Questionnaire (GCQ)
Description
the most commonly used group process instrument. It is a self-report, 12-item questionnaire that assesses the person's perceptions of the group's therapeutic environment. Items are scored on a 7-point Likert scale ranging from "Not at all" to "Extremely." The three subscales includes Engagement (the level of positive working group atmosphere), Conflict (the level of anger and tension in the group), and Avoidance (the level of behaviors indicating avoidance of personal responsibility of group work by the members).
Time Frame
3 months
Title
Group Session Rating Scale (GSRS)
Description
This is a 4-item questionnaire that assesses a person's feelings and perceptions towards the group content and relationships. Items are measured on an analog scale, ranging from 1-10. The four items measure four different aspects of the group environment including: Relationship, Goals, Acceptability, and Overall Fit.
Time Frame
3 months
Title
Patient-reported outcome measurement information system (PROMIS): General Self-Efficacy
Description
This measures a person's confidence in managing daily activities, emotions, medications/treatments, social interactions, and symptoms. Participants respond to each item using a scale from 1 (I am not at all confident) to 5 (I am very confident). Higher scores suggest higher perceived self-efficacy.
Time Frame
Through study completion, up to 5 months
Title
Quality of Life After Brain Injury (TBIQOL)
Description
This is a quality of life measure designed specifically for patients with brain injury. Participants respond to how satisfied they feel about each item using the following scale: 1 (Not at all), 2 (Slightly), 3 (Moderately), 4 (Quite), 5 (Very). Item scores are added and higher scores suggest higher perceived quality of life after brain injury.
Time Frame
Through study completion, up to 5 months
Title
Patient-reported outcome measurement information system (PROMIS): Health-Related Quality of Life (HRQL) Physical Function
Description
This is a part of an evaluation on a person's overall quality of life based on physical limitations and ability to participate socially. Participants rate each statement from 1 (unable to do) to 5 (without any difficulty). Higher scores suggest greater physical functioning ability.
Time Frame
Through study completion, up to 5 months
Title
Patient-reported outcome measurement information system (PROMIS): Health-Related Quality of Life (HRQL) Anxiety scale
Description
This is a part of an evaluation on a person's overall quality of life based on physical limitations and ability to participate socially. Participants rate each statement from 1 (Never) to 5 (Always). Higher scores suggest greater anxiety.
Time Frame
Through study completion, up to 5 months
Title
Patient-reported outcome measurement information system (PROMIS): Health-Related Quality of Life (HRQL) Depression scale
Description
This is a part of an evaluation on a person's overall quality of life based on physical limitations and ability to participate socially. Participants rate each statement from 1 (Never) to 5 (Always). Higher scores suggest greater depressive symptoms.
Time Frame
Through study completion, up to 5 months
Title
Patient-reported outcome measurement information system (PROMIS): Health-Related Quality of Life (HRQL) Fatigue scale
Description
This is a part of an evaluation on a person's overall quality of life based on physical limitations and ability to participate socially. Participants rate each statement from 1 (Not at all) to 5 (Very much). Higher scores suggest greater fatigue.
Time Frame
Through study completion, up to 5 months
Title
Patient-reported outcome measurement information system (PROMIS): Health-Related Quality of Life (HRQL) Sleep Disturbance scale
Description
This is a part of an evaluation on a person's overall quality of life based on physical limitations and ability to participate socially. Participants rate each statement from 1 (Not at all) to 5 (Very much). Higher scores suggest greater sleep disturbance (worse sleep).
Time Frame
Through study completion, up to 5 months
Title
Patient-reported outcome measurement information system (PROMIS): Health-Related Quality of Life (HRQL) Ability to Participate in Social Roles and Activities scale
Description
This is a part of an evaluation on a person's overall quality of life based on physical limitations and ability to participate socially. Participants rate each statement from 1 (Always) to 5 (Never). Higher scores suggest greater ability to participate in social roles and activities.
Time Frame
Through study completion, up to 5 months
Title
Patient-reported outcome measurement information system (PROMIS): Health-Related Quality of Life (HRQL) Pain Interference scale
Description
This is a part of an evaluation on a person's overall quality of life based on physical limitations and ability to participate socially. Participants rate each statement from 1 (Not at all) to 5 (Very much). Higher scores suggest greater likelihood that pain is interfering with the participant's every functioning.
Time Frame
Through study completion, up to 5 months
Title
Patient-reported outcome measurement information system (PROMIS): Health-Related Quality of Life (HRQL) Pain Intensity scale
Description
This is a part of an evaluation on a person's overall quality of life based on physical limitations and ability to participate socially. Participants rate their pain on a 0 to 10 scale (0 = no pain, 10 = worse pain imaginable).
Time Frame
Through study completion, up to 5 months
Title
Therapeutic Factors Inventory (TFI)
Description
This a 7-point Likert scale for group settings. It measures one's feeling of acceptance in a group setting, as well as sense of belonging, working together, trust, and caring. The scale ranges from 1 (Strongly Disagree) to 7 (Strongly Agree). Higher scores suggest greater positivity about group acceptance, trust, caring, and working together.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Participants enrolled in the study will be (1) persons with a history of brain injury (e.g., Traumatic Brain Injury; TBI) or acquired BI (e.g., stroke, hypoxia, ruptured aneurysm, or metabolic encephalopathy) OR a caregiver of a brain injury survivor; (2) 18 years of age and older; and (3) at least six months post-injury. Since there is no reason to believe that treatment effectiveness varies with chronicity, no maximum has been set for time post-injury.
Exclusion Criteria:
Participants will not be included in the study if they present with the following: (1) at imminent risk of psychiatric breakdown, or in imminent danger of hurting themselves or others; (2) active psychosis; (3) aphasia that limits group participation; or (4) significant neurobehavioral difficulties that would be deemed disruptive to group participation.
Facility Information:
Facility Name
Rehabilitation Hospital of Indiana
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46268
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Brain Injury Coping Skills - Telemedicine: Phase II
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