TBI (Traumatic Brain Injury)NCT03385824
Self-Advocacy for Independent Life (SAIL) After TBI
A study testing Self-Advocacy for Independent Life (SAIL) in people with TBI (Traumatic Brain Injury), run by Craig Hospital at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- TBI (Traumatic Brain Injury)
- What is being tested?
- Self-Advocacy for Independent Life (SAIL)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2018to 31 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Self-Advocacy for Independent Life (SAIL) After Traumatic Brain Injury
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.
- Conditions
- TBI (Traumatic Brain Injury)
- Being tested
- Self-Advocacy for Independent Life (SAIL)
- Keywords
- traumatic brain injury, advocacy
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-Advocacy for Independent Life (SAIL)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Self-Advocacy for Independent Life (SAIL) | Experimental | 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. Receives: Behavioral: Self-Advocacy for Independent Life (SAIL) |
| Control | No intervention | SAIL workbook provided at the conclusion of the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change in SAS score from Baseline to 11 weeks (immediately post-tx)
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.
Measured: Change in SAS score from Baseline to 17 weeks (6 weeks post-tx)
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.
Measured: Change in SAS score from Baseline to 23 weeks (12 weeks post-tx)
Secondary outcomes (15)
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.
Measured: Change in PAAS score from Baseline to 11 weeks (immediately post-tx)
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.
Measured: Change in PAAS score from Baseline to 17 weeks (6 weeks post-tx)
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.
Measured: Change in PAAS score from Baseline to 23 weeks (12 weeks post-tx)
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.
Measured: Change in GSES score from Baseline to 11 weeks (immediately post-tx)
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.
Measured: Change in GSES score from Baseline to 17 weeks (6 weeks post-tx)
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.
Measured: Change in GSES score from Baseline to 23 weeks (12 weeks post-tx)
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
Measured: Change in SWLS score from Baseline to 11 weeks (immediately post-tx)
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
Measured: Change in SWLS score from Baseline to 17 weeks (6 weeks post-tx)
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
Measured: Change in SWLS score from Baseline to 23 weeks (12 weeks post-tx)
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.
Measured: Change in total Flourishing Scale score from Baseline to 11 weeks (immediately post-tx)
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.
Measured: Change in total Flourishing Scale from Baseline to 17 weeks (6 weeks post-tx)
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.
Measured: Change in total Flourishing Scale score from Baseline to 23 weeks (12 weeks post-tx)
Participation Assessment with Recombined Tools-Objective (PART-O)
Objective measure of participation in society
Measured: Change in PART-O score from Baseline to 11 weeks (immediately post-tx)
Participation Assessment with Recombined Tools-Objective (PART-O)
Objective measure of participation in society
Measured: Change in PART-O score from Baseline to 17 weeks (6 weeks post-tx)
Participation Assessment with Recombined Tools-Objective (PART-O)
Objective measure of participation in society
Measured: Change in PART-O score from Baseline to 23 weeks (12 weeks post-tx)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2017
- Study start1 Feb 2018
- Primary completion31 Mar 2020
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TBI (Traumatic Brain Injury)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Craig Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lenore Hawley, Craig Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03385824
- Sponsor's protocol ID
- NIDILRR SAIL 2017
- Status last verified
- Jul 2020
- First submitted
- 19 Dec 2017
- Last updated
- 8 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-Advocacy for Independent Life (SAIL) After Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT03385824
- Acronym / sponsor ID
- NIDILRR SAIL 2017
- Conditions
- TBI (Traumatic Brain Injury)
- Keywords
- traumatic brain injury, advocacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Craig HospitalUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 29 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self-Advocacy for Independent Life (SAIL) | Experimental | Behavioral: 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. |
| Control | No intervention | –SAIL workbook provided at the conclusion of the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Self-Advocacy for Independent Life (SAIL) |
Primary outcome
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.
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.
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.
15 secondary outcomes
Personal Advocacy Activity Scale (PAAS)
Time frame: Change in PAAS score from Baseline to 11 weeks (immediately post-tx)
Personal Advocacy Activity Scale (PAAS)
Time frame: Change in PAAS score from Baseline to 17 weeks (6 weeks post-tx)
Personal Advocacy Activity Scale (PAAS)
Time frame: Change in PAAS score from Baseline to 23 weeks (12 weeks post-tx)
General Self Efficacy Scale (GSES)
Time frame: Change in GSES score from Baseline to 11 weeks (immediately post-tx)
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)
Time frame: Change in GSES score from Baseline to 23 weeks (12 weeks post-tx)
Satisfaction With Life Scale (SWLS)
Time frame: Change in SWLS score from Baseline to 11 weeks (immediately post-tx)
Satisfaction With Life Scale (SWLS)
Time frame: Change in SWLS score from Baseline to 17 weeks (6 weeks post-tx)
Satisfaction With Life Scale (SWLS)
Time frame: Change in SWLS score from Baseline to 23 weeks (12 weeks post-tx)
Flourishing Scale (FS)
Time frame: Change in total Flourishing Scale score from Baseline to 11 weeks (immediately post-tx)
Flourishing Scale (FS)
Time frame: Change in total Flourishing Scale from Baseline to 17 weeks (6 weeks post-tx)
Flourishing Scale (FS)
Time frame: Change in total Flourishing Scale score from Baseline to 23 weeks (12 weeks post-tx)
Participation Assessment with Recombined Tools-Objective (PART-O)
Time frame: Change in PART-O score from Baseline to 11 weeks (immediately post-tx)
Participation Assessment with Recombined Tools-Objective (PART-O)
Time frame: Change in PART-O score from Baseline to 17 weeks (6 weeks post-tx)
Participation Assessment with Recombined Tools-Objective (PART-O)
Time frame: Change in PART-O score from Baseline to 23 weeks (12 weeks post-tx)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-Advocacy for Independent Life (SAIL) in people with TBI (Traumatic Brain Injury), run by Craig Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-Advocacy Scale (SAS) (time frame: Change in SAS score from Baseline to 11 weeks (immediately post-tx)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2020.