Maintaining Autonomy as we Age: A Strategy Training Approach to Ameliorating the Effects of Age-related Executive Dysfunction.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Deirdre Dawson, Baycrest
ClinicalTrials.gov Identifier:
NCT01163279
First received: July 14, 2010
Last updated: March 21, 2012
Last verified: March 2012
  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
Aged
Behavioral: Real world strategy approach
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 Baycrest:

Primary Outcome Measures:
  • Changes in performance on Canadian Occupational Performance Measure (COPM) [ Time Frame: One year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in neuropsychological assessments of executive functions [ Time Frame: One year ] [ Designated as safety issue: No ]

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)
Intervention Details:
    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 CO-OP
  Eligibility

Ages Eligible for Study:   65 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • All participants must score within 1.5 SDs 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 MCI).
  • No clinically relevant depression (scores ≤22) on the 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
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: NCT01163279

Locations
Canada, Ontario
Baycrest
Toronto, Ontario, Canada, M6A 2E1
Sponsors and Collaborators
Baycrest
  More Information

No publications provided

Responsible Party: Deirdre Dawson, Senior Scientist, Baycrest
ClinicalTrials.gov Identifier: NCT01163279     History of Changes
Other Study ID Numbers: REB1021
Study First Received: July 14, 2010
Last Updated: March 21, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by Baycrest:
Age-related changes

ClinicalTrials.gov processed this record on July 31, 2014