Managing Dysexecutive Syndrome (DS): CIHR 2011-2014

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Baycrest
Sponsor:
Information provided by (Responsible Party):
Deirdre Dawson, Baycrest
ClinicalTrials.gov Identifier:
NCT01414348
First received: August 10, 2011
Last updated: January 8, 2014
Last verified: January 2014
  Purpose

Successful community participation following acquired brain injury (ABI) continues to be an elusive goal for patients, clinicians and researchers. Our pilot work shows that community dwelling survivors of ABI can significantly improve performance on self-identified real- world performance problems and that they can transfer this learning to improve goals not trained in the treatment sessions. We will compare two types of rehabilitation intervention using a randomized controlled trial. We will also interview survivors, their significant others and clinicians regarding their experiences with each intervention to help us discover what works best.


Condition Intervention
Traumatic Brain Injury
Cerebrovascular Accident (CVA)
Acquired Brain Injury
Behavioral: Conventional rehabilitation.
Behavioral: Novel rehabilitation approach

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Managing the Dysexecutive Syndrome Following Traumatic Brain Injury: An Ecologically Valid Rehabilitation Approach

Resource links provided by NLM:


Further study details as provided by Baycrest:

Primary Outcome Measures:
  • Change in performance on COPM [ Time Frame: pre, post, 3 month follow-up ] [ Designated as safety issue: No ]
    Canadian Occupational Performance Measure: standardized interview


Secondary Outcome Measures:
  • DEX, IADL profile [ Time Frame: pre, post, 3 month follow-up ] [ Designated as safety issue: No ]
    Perceived and observed impact of dysexecutive syndrome in everyday life


Estimated Enrollment: 120
Study Start Date: March 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Conventional rehabilitation
In-home work on problems in daily living.
Behavioral: Conventional rehabilitation.
1 hour / 2x / week for up to 15 sessions
Experimental: Novel rehabilitation approach Behavioral: Novel rehabilitation approach
1 hr, 2x/week for up to 15 sessions

Detailed Description:

Executive dysfunction is endemic after severe acquired brain injuries (ABIs) and is highly associated with long-lasting psychosocial distress, problems in a multiplicity of everyday activities and overall reduced quality of life. There is increasing evidence to suggest that a novel behavioral intervention is a treatment of choice for executive dysfunction. However few studies have addressed ecological relevance: failing to take into account the significant impact of the complex settings of real life on executive function. More data are desperately needed in this area given the devastating consequences of ABI. We propose to investigate the benefits of two community- based interventions.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • fluent in written and spoken English,
  • have sustained (1) a moderate to severe TBI as defined by a 6-hour GCS of 12 or less OR (2) complicated mild TBI with GCS 13-15 and associated abnormal findings on CT or MRI scan OR (3) other form of acquired brain injury (ABI) that is not related to a congenital, developmental or degenerative disorder but which occurred through a medical problem or disease process including stroke,

Exclusion Criteria: other significant neurological or psychiatric history such as multiple sclerosis or psychiatric illness requiring hospitalization, concurrent moderate to severe depression.

  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: NCT01414348

Contacts
Contact: Yael Y Bar, MSW 416-785-2500 ext 3377 ybar@research.baycrest.org

Locations
Canada, Ontario
Baycrest Centre for Geriatric Care Recruiting
Toronto, Ontario, Canada, M6A2E1
Contact: Deirdre D Dawson, PhD    416-785-2500 ext 2136    ddawson@research.baycrest.org   
Sponsors and Collaborators
Baycrest
Investigators
Principal Investigator: Deirdre D Dawson, PhD Baycrest centre
  More Information

No publications provided by Baycrest

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Deirdre Dawson, Dr. Deirdre Dawson, Senior Scientist Rotman Research Institute, Baycrest
ClinicalTrials.gov Identifier: NCT01414348     History of Changes
Other Study ID Numbers: REB1120
Study First Received: August 10, 2011
Last Updated: January 8, 2014
Health Authority: Canada: Ethics Review Committee
Canada: Canadian Institutes of Health Research

Keywords provided by Baycrest:
participation
activities of daily living
brain injuries
executive function

Additional relevant MeSH terms:
Cerebral Infarction
Stroke
Brain Injuries
Wounds and Injuries
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Craniocerebral Trauma
Trauma, Nervous System

ClinicalTrials.gov processed this record on July 31, 2014