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

NCT01163279 | Completed Results

• 1 other identifier: REB1021
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Aging

Keywords

Age-related changes

Outcome Measures

Primary Outcomes (1)

• Total Number of Goals Improved to Criterion on the Canadian Occupational Performance Measure (COPM)

  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.

  Immediately post intervention (2 months) and 3 months later

Secondary Outcomes (10)

• General Self Efficacy Scale (GSE)

  Baseline, Immediately post intervention (2 months) and 3 months later

• Stanford Patient Education Research Center- General Health Subscale

  Baseline, Immediately post intervention (2 months) and 3 months later

• Stanford Patient Education Research Center- Health Distress Subscale

  Baseline, Immediately post intervention (2 months) and 3 months later

• Stanford Patient Education Research Center- Physical Activity Subscale

  Baseline, Immediately post intervention (2 months) and 3 months later

• Stanford Patient Education Research Center- Communication With Physicians Subscale

  Baseline, Immediately post intervention (2 months) and 3 months later

Study Arms (2)

Cognitive Training

EXPERIMENTAL

Behavioral: Real world strategy approach

Psychosocial Education

ACTIVE COMPARATOR

Behavioral: Psychosocial Education

Interventions

Real world strategy approach BEHAVIORAL

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.

Also known as: Adopted Cognitive Orientation to Occupational Performance (CO-OP)

Cognitive Training

Psychosocial Education BEHAVIORAL

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.

Psychosocial Education

Eligibility Criteria

• Age: 65 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Recent bereavement (within last 6 months)
• History of neurological disease
• Psychiatric illness requiring hospitalization and/or history or current substance abuse

Sponsors & Collaborators

• Baycrest: lead

Study Sites (1)

Baycrest

Toronto, Ontario, M6A 2E1, Canada

Location

Results Point of Contact

• Title: Dr. Deirdre Dawson
• Organization: Baycrest Health Sciences

ddawson@research.baycrest.org

416-785-2500

Study Officials

• Deirdre Dawson, PhD

  Rotman Research Institute, Baycrest

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Scientist

Study Record Dates

• First Submitted: July 14, 2010
• First Posted: July 15, 2010
• Study Start: August 1, 2010
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: December 18, 2017
• Results First Posted: January 12, 2017

Record last verified: 2017-11

Locations

CA (1)