Managing Dysexecutive Syndrome (DS): CIHR 2011-2014

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

95 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2014-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Traumatic Brain Injury Cerebrovascular Accident (CVA) Acquired Brain Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Conventional rehabilitation

In-home work on problems in daily living.

Group Type ACTIVE_COMPARATOR

Conventional rehabilitation.

Intervention Type BEHAVIORAL

1 hour / 2x / week for up to 15 sessions

Novel rehabilitation approach

Group Type EXPERIMENTAL

Novel rehabilitation approach

Intervention Type BEHAVIORAL

1 hr, 2x/week for up to 15 sessions

Interventions

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Conventional rehabilitation.

1 hour / 2x / week for up to 15 sessions

Intervention Type BEHAVIORAL

Novel rehabilitation approach

1 hr, 2x/week for up to 15 sessions

Intervention Type BEHAVIORAL

Eligibility Criteria

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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,

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No