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Self-Advocacy for Independent Life (SAIL) After TBI

Primary Purpose

TBI (Traumatic Brain Injury)

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Self-Advocacy for Independent Life (SAIL)
Sponsored by
Craig Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for TBI (Traumatic Brain Injury) focused on measuring traumatic brain injury, advocacy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Documented TBI due to an external mechanical force
  • Received inpatient or outpatient rehabilitation for TBI
  • At least 9 months post TBI
  • Able to travel independently in the community
  • Able to attend intervention sessions

Exclusion Criteria:

  • Unable to read or speak English well enouth to complete assessments and actively participate in study intervention
  • Currently in inpatient TBI rehabilitation
  • Previously participated in a SAIL program
  • Participating in another research trial
  • Unable to perform neuropsychological baseline assessment
  • Score of 30 or above on GSES

Sites / Locations

  • Craig Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Self-Advocacy for Independent Life (SAIL)

Control

Arm Description

10 week treatment program to improve self-advocacy skills. Includes 4 in-person group sessions (3 hours per session) and two supportive phone calls; workbook and home assignments.

SAIL workbook provided at the conclusion of the study.

Outcomes

Primary Outcome Measures

Self-Advocacy Scale (SAS)
The Self-Advocacy Scale (SAS) is an eight-item 1-4 Likert rating scale (1 = not confident to 4 = very confident), conceptualized as a domain specific self-efficacy scale. The SAS is designed to measure an individual's current beliefs about his or her ability to produce desired self-advocacy outcomes. Scores range from 8 to 32 with higher scores indicative of better self-advocacy skills.
Self-Advocacy Scale (SAS)
The Self-Advocacy Scale (SAS) is an eight-item 1-4 Likert rating scale (1 = not confident to 4 = very confident), conceptualized as a domain specific self-efficacy scale. The SAS is designed to measure an individual's current beliefs about his or her ability to produce desired self-advocacy outcomes. Scores range from 8 to 32 with higher scores indicative of better self-advocacy skills.
Self-Advocacy Scale (SAS)
The Self-Advocacy Scale (SAS) is an eight-item 1-4 Likert rating scale (1 = not confident to 4 = very confident), conceptualized as a domain specific self-efficacy scale. The SAS is designed to measure an individual's current beliefs about his or her ability to produce desired self-advocacy outcomes. Scores range from 8 to 32 with higher scores indicative of better self-advocacy skills.

Secondary Outcome Measures

Personal Advocacy Activity Scale (PAAS)
The Personal Advocacy Activity Scale (PAAS) is a 12-item self-rating of personal advocacy behaviors. Participants respond to each item by indicating how frequently they perform each activity, "Not at all", "1 - 4 times", or "5 or more times". Scores range from 12 to 36 with higher scores indicating more personal advocacy behavior.
Personal Advocacy Activity Scale (PAAS)
The Personal Advocacy Activity Scale (PAAS) is a 12-item self-rating of personal advocacy behaviors. Participants respond to each item by indicating how frequently they perform each activity, "Not at all", "1 - 4 times", or "5 or more times". Scores range from 12 to 36 with higher scores indicating more personal advocacy behavior.
Personal Advocacy Activity Scale (PAAS)
The Personal Advocacy Activity Scale (PAAS) is a 12-item self-rating of personal advocacy behaviors. Participants respond to each item by indicating how frequently they perform each activity, "Not at all", "1 - 4 times", or "5 or more times". Scores range from 12 to 36 with higher scores indicating more personal advocacy behavior.
General Self Efficacy Scale (GSES)
General Self Efficacy Scale (GSES) is a 10-item Likert rating scale assessing beliefs about one's ability to cope with various demands in life, a core component of self-advocacy.The GSES produces a single score ranging from 10 to 40, with higher scores indicating greater general self-efficacy.
General Self Efficacy Scale (GSES)
General Self Efficacy Scale (GSES) is a 10-item Likert rating scale assessing beliefs about one's ability to cope with various demands in life, a core component of self-advocacy.The GSES produces a single score ranging from 10 to 40, with higher scores indicating greater general self-efficacy.
General Self Efficacy Scale (GSES)
General Self Efficacy Scale (GSES) is a 10-item Likert rating scale assessing beliefs about one's ability to cope with various demands in life, a core component of self-advocacy.The GSES produces a single score ranging from 10 to 40, with higher scores indicating greater general self-efficacy.
Satisfaction With Life Scale (SWLS)
The Satisfaction with Life Scale (SWLS) is a subjective, five-item 1-7 Likert rating scale measuring global life satisfaction - a cognitive self-assessment of quality of life. Scores range from 5 to 35 with higher scores indicative of greater life satisfaction
Satisfaction With Life Scale (SWLS)
The Satisfaction with Life Scale (SWLS) is a subjective, five-item 1-7 Likert rating scale measuring global life satisfaction - a cognitive self-assessment of quality of life. Scores range from 5 to 35 with higher scores indicative of greater life satisfaction
Satisfaction With Life Scale (SWLS)
The Satisfaction with Life Scale (SWLS) is a subjective, five-item 1-7 Likert rating scale measuring global life satisfaction - a cognitive self-assessment of quality of life. Scores range from 5 to 35 with higher scores indicative of greater life satisfaction
Flourishing Scale (FS)
The Flourishing Scale (FS) is a brief eight-item, self-rated, 1-7 point Likert scale measure of self-perceived success in areas such as social relationships, self-esteem, and purpose in life. Scores range from 5 to 35 with higher scores indicating better self-perceived success.
Flourishing Scale (FS)
The Flourishing Scale (FS) is a brief eight-item, self-rated, 1-7 point Likert scale measure of self-perceived success in areas such as social relationships, self-esteem, and purpose in life. Scores range from 5 to 35 with higher scores indicating better self-perceived success.
Flourishing Scale (FS)
The Flourishing Scale (FS) is a brief eight-item, self-rated, 1-7 point Likert scale measure of self-perceived success in areas such as social relationships, self-esteem, and purpose in life. Scores range from 5 to 35 with higher scores indicating better self-perceived success.
Participation Assessment with Recombined Tools-Objective (PART-O)
Objective measure of participation in society
Participation Assessment with Recombined Tools-Objective (PART-O)
Objective measure of participation in society
Participation Assessment with Recombined Tools-Objective (PART-O)
Objective measure of participation in society

Full Information

First Posted
December 19, 2017
Last Updated
July 7, 2020
Sponsor
Craig Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03385824
Brief Title
Self-Advocacy for Independent Life (SAIL) After TBI
Official Title
Self-Advocacy for Independent Life (SAIL) After Traumatic Brain Injury
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
February 1, 2018 (Actual)
Primary Completion Date
March 31, 2020 (Actual)
Study Completion Date
March 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Craig Hospital

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
Traumatic brain injury (TBI) has been conceptualized as a chronic health condition, warranting self-advocacy for health management services across the lifespan. Successful self-advocacy requires a combination of cognitive and communication skills (problem solving, organization, negotiation, etc), which may be impaired following TBI. This project focuses on developing and testing the efficacy of an intervention to enhance self-advocacy skills in individuals who have sustained TBI. This two-arm, randomized controlled trial will include approximately 74 participants, recruited in 4 waves of approximately 18-20 per wave, with each wave recruited from a different geographic area of the state. The primary hypothesis states that participants receiving the treatment intervention will demonstrate significantly greater improvements in self-advocacy beliefs (SAS) from baseline to post-intervention as compared to participants in the control group. Treatment will consist of interactive 4-session workshops along with 2 booster phone calls. Control participants will receive a copy of a self-advocacy workbook after all assessments are completed. Baseline, post-treatment and two follow-up assessments will take place.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
TBI (Traumatic Brain Injury)
Keywords
traumatic brain injury, advocacy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
76 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Self-Advocacy for Independent Life (SAIL)
Arm Type
Experimental
Arm Description
10 week treatment program to improve self-advocacy skills. Includes 4 in-person group sessions (3 hours per session) and two supportive phone calls; workbook and home assignments.
Arm Title
Control
Arm Type
No Intervention
Arm Description
SAIL workbook provided at the conclusion of the study.
Intervention Type
Behavioral
Intervention Name(s)
Self-Advocacy for Independent Life (SAIL)
Intervention Description
SAIL program is based on an interactive workshop model. In -person sessions will focus on: enhancement of self-efficacy beliefs; enhancement of knowledge of TBI self-advocacy information; group process to instill hope and universality; and practice of self-advocacy behaviors in a supportive neuro-rehabilitation structured group environment.
Primary Outcome Measure Information:
Title
Self-Advocacy Scale (SAS)
Description
The Self-Advocacy Scale (SAS) is an eight-item 1-4 Likert rating scale (1 = not confident to 4 = very confident), conceptualized as a domain specific self-efficacy scale. The SAS is designed to measure an individual's current beliefs about his or her ability to produce desired self-advocacy outcomes. Scores range from 8 to 32 with higher scores indicative of better self-advocacy skills.
Time Frame
Change in SAS score from Baseline to 11 weeks (immediately post-tx)
Title
Self-Advocacy Scale (SAS)
Description
The Self-Advocacy Scale (SAS) is an eight-item 1-4 Likert rating scale (1 = not confident to 4 = very confident), conceptualized as a domain specific self-efficacy scale. The SAS is designed to measure an individual's current beliefs about his or her ability to produce desired self-advocacy outcomes. Scores range from 8 to 32 with higher scores indicative of better self-advocacy skills.
Time Frame
Change in SAS score from Baseline to 17 weeks (6 weeks post-tx)
Title
Self-Advocacy Scale (SAS)
Description
The Self-Advocacy Scale (SAS) is an eight-item 1-4 Likert rating scale (1 = not confident to 4 = very confident), conceptualized as a domain specific self-efficacy scale. The SAS is designed to measure an individual's current beliefs about his or her ability to produce desired self-advocacy outcomes. Scores range from 8 to 32 with higher scores indicative of better self-advocacy skills.
Time Frame
Change in SAS score from Baseline to 23 weeks (12 weeks post-tx)
Secondary Outcome Measure Information:
Title
Personal Advocacy Activity Scale (PAAS)
Description
The Personal Advocacy Activity Scale (PAAS) is a 12-item self-rating of personal advocacy behaviors. Participants respond to each item by indicating how frequently they perform each activity, "Not at all", "1 - 4 times", or "5 or more times". Scores range from 12 to 36 with higher scores indicating more personal advocacy behavior.
Time Frame
Change in PAAS score from Baseline to 11 weeks (immediately post-tx)
Title
Personal Advocacy Activity Scale (PAAS)
Description
The Personal Advocacy Activity Scale (PAAS) is a 12-item self-rating of personal advocacy behaviors. Participants respond to each item by indicating how frequently they perform each activity, "Not at all", "1 - 4 times", or "5 or more times". Scores range from 12 to 36 with higher scores indicating more personal advocacy behavior.
Time Frame
Change in PAAS score from Baseline to 17 weeks (6 weeks post-tx)
Title
Personal Advocacy Activity Scale (PAAS)
Description
The Personal Advocacy Activity Scale (PAAS) is a 12-item self-rating of personal advocacy behaviors. Participants respond to each item by indicating how frequently they perform each activity, "Not at all", "1 - 4 times", or "5 or more times". Scores range from 12 to 36 with higher scores indicating more personal advocacy behavior.
Time Frame
Change in PAAS score from Baseline to 23 weeks (12 weeks post-tx)
Title
General Self Efficacy Scale (GSES)
Description
General Self Efficacy Scale (GSES) is a 10-item Likert rating scale assessing beliefs about one's ability to cope with various demands in life, a core component of self-advocacy.The GSES produces a single score ranging from 10 to 40, with higher scores indicating greater general self-efficacy.
Time Frame
Change in GSES score from Baseline to 11 weeks (immediately post-tx)
Title
General Self Efficacy Scale (GSES)
Description
General Self Efficacy Scale (GSES) is a 10-item Likert rating scale assessing beliefs about one's ability to cope with various demands in life, a core component of self-advocacy.The GSES produces a single score ranging from 10 to 40, with higher scores indicating greater general self-efficacy.
Time Frame
Change in GSES score from Baseline to 17 weeks (6 weeks post-tx)
Title
General Self Efficacy Scale (GSES)
Description
General Self Efficacy Scale (GSES) is a 10-item Likert rating scale assessing beliefs about one's ability to cope with various demands in life, a core component of self-advocacy.The GSES produces a single score ranging from 10 to 40, with higher scores indicating greater general self-efficacy.
Time Frame
Change in GSES score from Baseline to 23 weeks (12 weeks post-tx)
Title
Satisfaction With Life Scale (SWLS)
Description
The Satisfaction with Life Scale (SWLS) is a subjective, five-item 1-7 Likert rating scale measuring global life satisfaction - a cognitive self-assessment of quality of life. Scores range from 5 to 35 with higher scores indicative of greater life satisfaction
Time Frame
Change in SWLS score from Baseline to 11 weeks (immediately post-tx)
Title
Satisfaction With Life Scale (SWLS)
Description
The Satisfaction with Life Scale (SWLS) is a subjective, five-item 1-7 Likert rating scale measuring global life satisfaction - a cognitive self-assessment of quality of life. Scores range from 5 to 35 with higher scores indicative of greater life satisfaction
Time Frame
Change in SWLS score from Baseline to 17 weeks (6 weeks post-tx)
Title
Satisfaction With Life Scale (SWLS)
Description
The Satisfaction with Life Scale (SWLS) is a subjective, five-item 1-7 Likert rating scale measuring global life satisfaction - a cognitive self-assessment of quality of life. Scores range from 5 to 35 with higher scores indicative of greater life satisfaction
Time Frame
Change in SWLS score from Baseline to 23 weeks (12 weeks post-tx)
Title
Flourishing Scale (FS)
Description
The Flourishing Scale (FS) is a brief eight-item, self-rated, 1-7 point Likert scale measure of self-perceived success in areas such as social relationships, self-esteem, and purpose in life. Scores range from 5 to 35 with higher scores indicating better self-perceived success.
Time Frame
Change in total Flourishing Scale score from Baseline to 11 weeks (immediately post-tx)
Title
Flourishing Scale (FS)
Description
The Flourishing Scale (FS) is a brief eight-item, self-rated, 1-7 point Likert scale measure of self-perceived success in areas such as social relationships, self-esteem, and purpose in life. Scores range from 5 to 35 with higher scores indicating better self-perceived success.
Time Frame
Change in total Flourishing Scale from Baseline to 17 weeks (6 weeks post-tx)
Title
Flourishing Scale (FS)
Description
The Flourishing Scale (FS) is a brief eight-item, self-rated, 1-7 point Likert scale measure of self-perceived success in areas such as social relationships, self-esteem, and purpose in life. Scores range from 5 to 35 with higher scores indicating better self-perceived success.
Time Frame
Change in total Flourishing Scale score from Baseline to 23 weeks (12 weeks post-tx)
Title
Participation Assessment with Recombined Tools-Objective (PART-O)
Description
Objective measure of participation in society
Time Frame
Change in PART-O score from Baseline to 11 weeks (immediately post-tx)
Title
Participation Assessment with Recombined Tools-Objective (PART-O)
Description
Objective measure of participation in society
Time Frame
Change in PART-O score from Baseline to 17 weeks (6 weeks post-tx)
Title
Participation Assessment with Recombined Tools-Objective (PART-O)
Description
Objective measure of participation in society
Time Frame
Change in PART-O score from Baseline to 23 weeks (12 weeks post-tx)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Documented TBI due to an external mechanical force Received inpatient or outpatient rehabilitation for TBI At least 9 months post TBI Able to travel independently in the community Able to attend intervention sessions Exclusion Criteria: Unable to read or speak English well enouth to complete assessments and actively participate in study intervention Currently in inpatient TBI rehabilitation Previously participated in a SAIL program Participating in another research trial Unable to perform neuropsychological baseline assessment Score of 30 or above on GSES
Facility Information:
Facility Name
Craig Hospital
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Self-Advocacy for Independent Life (SAIL) After TBI

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