Clinical trial NCT01002677: Behavioral Trial Studying Programmed Training to Improve Advocacy Skills for Individuals With Traumatic Brain Injury
Official title: Midwest Advocacy Project: A Community-based Randomized Practical Behavioral Trial of Programmed Advocacy Training for Individuals With Traumatic Brain Injury and Their Significant Others
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Brain Injuries
Keywords: brain injury
traumatic brain injury
training
teaching
curriculum
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2009-10-27
Enrollment: 234
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The Midwest Advocacy Project (MAP) is a community-based multiple-site randomized practical behavioral trial of advocacy skill training for individuals with traumatic brain injury (TBI), their families, and significant others. The purpose is to evaluate the efficacy of a 4-session advocacy training program to improve behavioral advocacy skills compared to self-directed advocacy training of the same session frequency. Groups will be randomly assigned to either a programmed group or a self-directed group in collaboration with the Brain Injury Associations of Minnesota, Iowa, and Wisconsin each year over the 5 year study period. The primary outcome is pre-post measures of written and verbal advocacy skill measured by the Advocacy Behavior Rating Scale.

It is hypothesized that subjects who receive programmed advocacy training will show greater positive change on pre-post measures of advocacy skill measures than subjects receiving self-directed training.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* moderate-severe TBI as indicated by one of the following:
* post traumatic amnesia (PTA) \> 24 hours
* or loss of consciousness \> 30 minutes
* or neuroimaging evidence of trauma-related intracranial abnormality
* Or the family/significant other of an individual with TBI meeting the above criteria
* 1 or more years post-injury
* Functional English speaker
* Signed consent to participate

Exclusion Criteria:

* Severe cognitive impairment as indicated by one or more of the following:
* Disorientation to person or year
* Unable to complete pre-program interview because of severe communication limitations
* Unable to remember important information given in the course of the pre-program interview, such as, time and place of program, number of sessions, and contact person
* Unable to complete the pre-program interview because of loss of emotional control, such as, extended tearfulness, sustained anger, verbal attack on interviewer

Primary outcomes:
measure: Score on the Advocacy Behavior Rating Scale
timeFrame: Written and verbal (video) advocacy statements are obtained twice from each subject and rated by blinded investigators: once after consenting and before beginning the group's advocacy activity, and; after the last advocacy activity session 4 weeks later.
Secondary outcomes:
measure: Score on Advocacy Activity Scale
timeFrame: The Advocacy Activity Scale score is obtained twice from each subject: once after consenting and before beginning the group's advocacy activity, and; after the last advocacy activity session 4 weeks later.
measure: Score on the Perceived Control Scale for Brain Injury
timeFrame: The Perceived Control Scale for Brain Injury score is obtained twice from each subject: once after consenting and before beginning the group's advocacy activity, and; after the last advocacy activity session 4 weeks later.
measure: The Craig Hospital Inventory of Environmental Factors-Short Form
timeFrame: The Craig Hospital Inventory of Environmental Factors-Short Form score is obtained twice from each subject: once after consenting and before beginning the group's advocacy activity, and; after the last advocacy activity session 4 weeks later.
measure: The Satisfaction with Life Scale
timeFrame: The Satisfaction with Life Scale is obtained twice from each subject: once after consenting and before beginning the group's advocacy activity, and; after the last advocacy activity session 4 weeks later.
measure: The SF-12
timeFrame: The SF-12 score is obtained twice from each subject: once after consenting and before beginning the group's advocacy activity, and; after the last advocacy activity session 4 weeks later.
measure: Advocacy Activity Scale
timeFrame: Every 6 months after intervention until the end of the 5-year study period
Other outcomes:
Locations:
city: Urbandale
country: United States
facility: Brain Injury Association of Iowa
state: Iowa
city: Minneapolis
country: United States
facility: Brain Injury Association of Minnesota
state: Minnesota
city: Pewaukee
country: United States
facility: Brain Injury Association of Wisconsin
state: Wisconsin
Study officials:
affiliation: Mayo Clinic
name: Allen W Brown, MD
role: PRINCIPAL_INVESTIGATOR
References: