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

History of Changes

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:

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

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 May 19, 2013

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