Behavioral Trial Studying Programmed Training to Improve Advocacy Skills for Individuals With Traumatic Brain Injury (MAP)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allen Brown, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01002677
First received: October 22, 2009
Last updated: January 16, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Brain Injuries
Behavioral: Advocacy training curriculum
Behavioral: Self-directed
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
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

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Score on the Advocacy Behavior Rating Scale [ Time Frame: 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Score on Advocacy Activity Scale [ Time Frame: 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. ] [ Designated as safety issue: No ]
  • Score on the Perceived Control Scale for Brain Injury [ Time Frame: 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. ] [ Designated as safety issue: No ]
  • The Craig Hospital Inventory of Environmental Factors-Short Form [ Time Frame: 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. ] [ Designated as safety issue: No ]
  • The Satisfaction with Life Scale [ Time Frame: 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. ] [ Designated as safety issue: No ]
  • The SF-12 [ Time Frame: 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. ] [ Designated as safety issue: No ]
  • Advocacy Activity Scale [ Time Frame: Every 6 months after intervention until the end of the 5-year study period ] [ Designated as safety issue: No ]

Enrollment: 234
Study Start Date: August 2007
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Curriculum Behavioral: Advocacy training curriculum
Day-long presentation of an advocacy training curriculum by the state's Brain Injury Association staff: One session per month for 4 consecutive months.
Active Comparator: Self-directed Behavioral: Self-directed
Day-long group-based self-directed advocacy training activity: One session per month for 4 consecutive months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01002677

Locations
United States, Iowa
Brain Injury Association of Iowa
Urbandale, Iowa, United States, 50322
United States, Minnesota
Brain Injury Association of Minnesota
Minneapolis, Minnesota, United States, 55413
United States, Wisconsin
Brain Injury Association of Wisconsin
Pewaukee, Wisconsin, United States, 53072
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Allen W Brown, MD Mayo Clinic
  More Information

No publications provided

Responsible Party: Allen Brown, Director, Brain Rehabilitation Research, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01002677     History of Changes
Other Study ID Numbers: 08-000981, H133A070013-09
Study First Received: October 22, 2009
Last Updated: January 16, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
brain injury
traumatic brain injury
training
teaching
curriculum

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

ClinicalTrials.gov processed this record on September 16, 2014