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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01163279
First Posted: July 15, 2010
Last Update Posted: January 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Dr. Deirdre Dawson, Baycrest
  Purpose
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.

Condition Intervention Phase
Aging Behavioral: Real world strategy approach Behavioral: Psychosocial Education Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Official Title: Maintaining Autonomy as we Age: Investigating the Application of a Strategy Training Approach for Ameliorating the Effects of Age-related Executive Dysfunction - Part II

Further study details as provided by Dr. Deirdre Dawson, Baycrest:

Primary Outcome Measures:
  • 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 ]
    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.


Secondary Outcome Measures:
  • General Self Efficacy Scale (GSE) [ Time Frame: Baseline, Immediately post intervention (2 months) and 3 months later ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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


Enrollment: 19
Study Start Date: August 2010
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cognitive Training 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)
Active Comparator: Psychosocial Education 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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01163279


Locations
Canada, Ontario
Baycrest
Toronto, Ontario, Canada, M6A 2E1
Sponsors and Collaborators
Baycrest
Investigators
Principal Investigator: Deirdre Dawson, PhD Rotman Research Institute, Baycrest
  More Information

Responsible Party: Dr. Deirdre Dawson, Senior Scientist, Baycrest
ClinicalTrials.gov Identifier: NCT01163279     History of Changes
Other Study ID Numbers: REB1021
First Submitted: July 14, 2010
First Posted: July 15, 2010
Results First Submitted: January 12, 2016
Results First Posted: January 12, 2017
Last Update Posted: January 12, 2017
Last Verified: November 2016

Keywords provided by Dr. Deirdre Dawson, Baycrest:
Age-related changes