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Self-Advocacy for Independent Life (SAIL) After TBI

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ClinicalTrials.gov Identifier: NCT03385824
Recruitment Status : Recruiting
First Posted : December 29, 2017
Last Update Posted : August 2, 2018
Sponsor:
Information provided by (Responsible Party):
Lenore Hawley, Craig Hospital

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.

Condition or disease Intervention/treatment Phase
TBI (Traumatic Brain Injury) Behavioral: Self-Advocacy for Independent Life (SAIL) Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Self-Advocacy for Independent Life (SAIL) After Traumatic Brain Injury
Actual Study Start Date : February 1, 2018
Estimated Primary Completion Date : January 31, 2020
Estimated Study Completion Date : January 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Self-Advocacy for Independent Life (SAIL)
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.
Behavioral: Self-Advocacy for Independent Life (SAIL)
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.

No Intervention: Control
SAIL workbook provided at the conclusion of the study.



Primary Outcome Measures :
  1. Self-Advocacy Scale (SAS) [ Time Frame: Change in SAS score from Baseline to 11 weeks (immediately post-tx) ]
    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.

  2. Self-Advocacy Scale (SAS) [ Time Frame: Change in SAS score from Baseline to 17 weeks (6 weeks post-tx) ]
    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.

  3. Self-Advocacy Scale (SAS) [ Time Frame: Change in SAS score from Baseline to 23 weeks (12 weeks post-tx) ]
    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 :
  1. Personal Advocacy Activity Scale (PAAS) [ Time Frame: Change in PAAS score from Baseline to 11 weeks (immediately post-tx) ]
    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.

  2. Personal Advocacy Activity Scale (PAAS) [ Time Frame: Change in PAAS score from Baseline to 17 weeks (6 weeks post-tx) ]
    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.

  3. Personal Advocacy Activity Scale (PAAS) [ Time Frame: Change in PAAS score from Baseline to 23 weeks (12 weeks post-tx) ]
    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.

  4. General Self Efficacy Scale (GSES) [ Time Frame: Change in GSES score from Baseline to 11 weeks (immediately post-tx) ]
    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.

  5. General Self Efficacy Scale (GSES) [ Time Frame: Change in GSES score from Baseline to 17 weeks (6 weeks post-tx) ]
    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.

  6. General Self Efficacy Scale (GSES) [ Time Frame: Change in GSES score from Baseline to 23 weeks (12 weeks post-tx) ]
    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.

  7. Satisfaction With Life Scale (SWLS) [ Time Frame: Change in SWLS score from Baseline to 11 weeks (immediately post-tx) ]
    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

  8. Satisfaction With Life Scale (SWLS) [ Time Frame: Change in SWLS score from Baseline to 17 weeks (6 weeks post-tx) ]
    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

  9. Satisfaction With Life Scale (SWLS) [ Time Frame: Change in SWLS score from Baseline to 23 weeks (12 weeks post-tx) ]
    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

  10. Flourishing Scale (FS) [ Time Frame: Change in total Flourishing Scale score from Baseline to 11 weeks (immediately post-tx) ]
    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.

  11. Flourishing Scale (FS) [ Time Frame: Change in total Flourishing Scale from Baseline to 17 weeks (6 weeks post-tx) ]
    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.

  12. Flourishing Scale (FS) [ Time Frame: Change in total Flourishing Scale score from Baseline to 23 weeks (12 weeks post-tx) ]
    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.

  13. Participation Assessment with Recombined Tools-Objective (PART-O) [ Time Frame: Change in PART-O score from Baseline to 11 weeks (immediately post-tx) ]
    Objective measure of participation in society

  14. Participation Assessment with Recombined Tools-Objective (PART-O) [ Time Frame: Change in PART-O score from Baseline to 17 weeks (6 weeks post-tx) ]
    Objective measure of participation in society

  15. Participation Assessment with Recombined Tools-Objective (PART-O) [ Time Frame: Change in PART-O score from Baseline to 23 weeks (12 weeks post-tx) ]
    Objective measure of participation in society



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03385824


Contacts
Contact: Clare Morey, MA 303-789-8621 cmorey@craighospital.org
Contact: Lenore Hawley, MSSW 303-789-8570 lhawley@craighospital.org

Locations
United States, Colorado
Craig Hospital Recruiting
Englewood, Colorado, United States, 80113
Contact: Clare Morey, MA    303-789-8621    cmorey@craighospital.org   
Sponsors and Collaborators
Craig Hospital

Responsible Party: Lenore Hawley, Principal Investigator, Craig Hospital
ClinicalTrials.gov Identifier: NCT03385824     History of Changes
Other Study ID Numbers: NIDILRR SAIL 2017
First Posted: December 29, 2017    Key Record Dates
Last Update Posted: August 2, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Lenore Hawley, Craig Hospital:
traumatic brain injury
advocacy

Additional relevant MeSH terms:
Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries