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

August 10, 2011
January 8, 2014
March 2012
August 2014   (final data collection date for primary outcome measure)
Change in performance on COPM [ Time Frame: pre, post, 3 month follow-up ] [ Designated as safety issue: No ]
Canadian Occupational Performance Measure: standardized interview
Same as current
Complete list of historical versions of study NCT01414348 on ClinicalTrials.gov Archive Site
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
DEX, MET [ Time Frame: pre, post, 3 month follow-up ] [ Designated as safety issue: No ]
Perceived and observed impact of dysexecutive syndrome in everyday life
Not Provided
Not Provided
 
Managing Dysexecutive Syndrome (DS): CIHR 2011-2014
Managing the Dysexecutive Syndrome Following Traumatic Brain Injury: An Ecologically Valid Rehabilitation Approach

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
  • Traumatic Brain Injury
  • Cerebrovascular Accident (CVA)
  • Acquired Brain Injury
  • Behavioral: Conventional rehabilitation.
    1 hour / 2x / week for up to 15 sessions
  • Behavioral: Novel rehabilitation approach
    1 hr, 2x/week for up to 15 sessions
  • Active Comparator: Conventional rehabilitation
    In-home work on problems in daily living.
    Intervention: Behavioral: Conventional rehabilitation.
  • Experimental: Novel rehabilitation approach
    Intervention: Behavioral: Novel rehabilitation approach
Dawson DR, Anderson ND, Binns MA, Bottari C, Damianakis T, Hunt A, Polatajko HJ, Zwarenstein M. Managing executive dysfunction following acquired brain injury and stroke using an ecologically valid rehabilitation approach: a study protocol for a randomized, controlled trial. Trials. 2013 Sep 22;14:306. doi: 10.1186/1745-6215-14-306.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
December 2014
August 2014   (final data collection date for primary outcome measure)

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.

Both
18 Years and older
No
Contact: Yael Y Bar, MSW 416-785-2500 ext 3377 ybar@research.baycrest.org
Canada
 
NCT01414348
REB1120
Yes
Deirdre Dawson, Baycrest
Baycrest
Not Provided
Principal Investigator: Deirdre D Dawson, PhD Baycrest centre
Baycrest
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP