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Maintaining Autonomy as we Age. Strategy Training for Age-related Executive Dysfunction.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Deirdre Dawson, Baycrest
ClinicalTrials.gov Identifier:
NCT01163279
First received: July 14, 2010
Last updated: November 17, 2016
Last verified: November 2016

July 14, 2010
November 17, 2016
August 2010
October 2011   (final data collection date for primary outcome measure)
Total Number of Goals Improved to Criterion on the Canadian Occupational Performance Measure (COPM) [ Time Frame: Immediately post intervention (2 months) and 3 months later ] [ Designated as safety issue: No ]
COPM is a standardized semi-structure interview in which participants identify goals related to everyday life activities. Goals considered improved to criterion are those that had 2 or more points increase on COPM ratings.
Changes in performance on Canadian Occupational Performance Measure (COPM) [ Time Frame: One year ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01163279 on ClinicalTrials.gov Archive Site
  • General Self Efficacy Scale (GSE) [ Time Frame: Baseline, Immediately post intervention (2 months) and 3 months later ] [ Designated as safety issue: No ]
    GSE is a self efficacy scale with a minimum score of 10 and a maximum score of 40. Higher scores indicate higher self efficacy
  • Stanford Patient Education Research Center- General Health Subscale [ Time Frame: Baseline, Immediately post intervention (2 months) and 3 months later ] [ Designated as safety issue: No ]
    Stanford Patient Education Research Center has different measures of health related behaviors. General Health is one of the subscales. scores range 1-5 and higher score indicate better general health
  • Stanford Patient Education Research Center- Health Distress Subscale [ Time Frame: Baseline, Immediately post intervention (2 months) and 3 months later ] [ Designated as safety issue: No ]
    Stanford Patient Education Research Center has different measures of health related behaviors. Health distress is one of the subscales. Scores range 0-20 and higher score indicates more distress.
  • Stanford Patient Education Research Center- Physical Activity Subscale [ Time Frame: Baseline, Immediately post intervention (2 months) and 3 months later ] [ Designated as safety issue: No ]
    Stanford Patient Education Research Center has different measures of health related behaviors. Physical activity is one of the subscales. Scores indicate number of hours of physical activity per week
  • Stanford Patient Education Research Center- Communication With Physicians Subscale [ Time Frame: Baseline, Immediately post intervention (2 months) and 3 months later ] [ Designated as safety issue: No ]
    Stanford Patient Education Research Center has different measures of health related behaviors. communication with physicians is one of the subscales. Scores range 1-15 and higher score indicates more preparation for visits and greater ability to ask questions
  • Stanford Patient Education Research Center- Visits to Physician and Emergency Department in the Past Six Months Subscale [ Time Frame: Baseline, Immediately post intervention (2 months) and 3 months later ] [ Designated as safety issue: No ]
    Stanford Patient Education Research Center has different measures of health related behaviors. Visits to physician and emergency department in the past six months subscale is one of the subscales.
  • Delis Kaplan Executive Function System (DKEFS) Tower Test- Mean First-Move Time [ Time Frame: Baseline, Immediately post intervention (2 months) and 3 months later ] [ Designated as safety issue: No ]
    This is a measure of executive function. The score reflects the average of the participant's first-move times, i.e. the time a participant took to make the first move
  • DKEFS Tower Test- Achievement Score [ Time Frame: Baseline, Immediately post intervention (2 months) and 3 months later ] [ Designated as safety issue: No ]
    This is a measure of executive function. Total achievement scores indicate the highest score participants scored on the test. The lowest score possible is 0 and the highest score possible is 30. Higher scores indicate better performance.
  • DKEFS Word Fluency [ Time Frame: Baseline, Immediately post intervention (2 months) and 3 months later ] [ Designated as safety issue: No ]
    This is a measure of executive function where participants are given a letter and asked to generate as many words as they can think of within 60 seconds
  • DKEFS Trail Making- Condition 4: Number-letter Switching [ Time Frame: Baseline, Immediately post intervention (2 months) and 3 months later ] [ Designated as safety issue: No ]
    DKEFS trail making condition 4 is a measure of executive function that requires the participant to switch back and forth between connecting numbers and letters in a sequence
Changes in neuropsychological assessments of executive functions [ Time Frame: One year ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Maintaining Autonomy as we Age. Strategy Training for Age-related Executive Dysfunction.
Maintaining Autonomy as we Age: Investigating the Application of a Strategy Training Approach for Ameliorating the Effects of Age-related Executive Dysfunction - Part II
Healthy older adults with self-reported cognitive difficulties who receive strategy training will demonstrate greater performance benefits on measures of real-world activities, relative to those receiving a control intervention, immediately post treatment and at follow-up.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Aging
  • Behavioral: Real world strategy approach
    The key features of the protocol are: i. Participants are actively engaged in selecting their treatment goals. The research clinician will work with the participants to identify five specific, measurable real-world goals using a standardized semi-structured interview, the Canadian Occupational Performance Measure. Three of these will be training goals, two will not be trained but evaluated post-intervention for evidence of generalization and transfer to non-trained tasks; ii. A global problem solving approach is used (Goal- Plan- Do- Check). Participants are guided by the trainer to apply this strategy to their goals.
    Other Name: Adopted Cognitive Orientation to Occupational Performance (CO-OP)
  • Behavioral: Psychosocial Education
    The active comparator uses an information-based format and is designed to engage participants without providing any specific training techniques or strategies. During weekly sessions, participants will receive factual information on brain structure and function, age-related cognitive changes, and general brain health issues and will spend time doing non-specific cognitive exercises including crossword and Sudoku puzzles. Homework will consist of reading assignments related to the session topics.
  • Experimental: Cognitive Training
    Intervention: Behavioral: Real world strategy approach
  • Active Comparator: Psychosocial Education
    Intervention: Behavioral: Psychosocial Education
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
19
October 2011
October 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • All participants must score within 1.5 standard deviation (SD) of age and education-corrected normative data for the Montreal Cognitive Assessment and on a battery of neuropsychological tests of attention, memory and executive function (which will insure that participants are unlikely to meet the criteria for Mild Cognitive Impairment (MCI)).
  • No clinically relevant depression (scores ≤22) on the Center for Epidemiologic Studies Depression Scale (CES-D)
  • Fluent in written and spoken English
  • Self-reported complains about cognitive function

Exclusion Criteria:

  • Recent bereavement (within last 6 months)
  • History of neurological disease
  • Psychiatric illness requiring hospitalization and/or history or current substance abuse
All
65 Years to 90 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01163279
REB1021
No
Not Provided
Not Provided
Dr. Deirdre Dawson, Baycrest
Baycrest
Not Provided
Principal Investigator: Deirdre Dawson, PhD Rotman Research Institute, Baycrest
Baycrest
November 2016

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