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

Aging Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01163279
• Other study ID #: REB1021
• Status: Completed
• Phase: N/A
• First received: July 14, 2010
• Last updated: November 8, 2017
• Start date: August 2010
• Est. completion date: October 2011

Study information

• Verified date: November 2017
• Source: Baycrest
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Aging

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	Baycrest	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Baycrest

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	General Self Efficacy Scale (GSE)	GSE is a self efficacy scale with a minimum score of 10 and a maximum score of 40. Higher scores indicate higher self efficacy	Baseline, Immediately post intervention (2 months) and 3 months later
Secondary	Stanford Patient Education Research Center- General Health Subscale	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	Baseline, Immediately post intervention (2 months) and 3 months later
Secondary	Stanford Patient Education Research Center- Health Distress Subscale	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.	Baseline, Immediately post intervention (2 months) and 3 months later
Secondary	Stanford Patient Education Research Center- Physical Activity Subscale	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	Baseline, Immediately post intervention (2 months) and 3 months later
Secondary	Stanford Patient Education Research Center- Communication With Physicians Subscale	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	Baseline, Immediately post intervention (2 months) and 3 months later
Secondary	Stanford Patient Education Research Center- Visits to Physician and Emergency Department in the Past Six Months Subscale	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.	Baseline, Immediately post intervention (2 months) and 3 months later
Secondary	Delis Kaplan Executive Function System (DKEFS) Tower Test- Mean First-Move Time	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	Baseline, Immediately post intervention (2 months) and 3 months later
Secondary	DKEFS Tower Test- Achievement Score	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.	Baseline, Immediately post intervention (2 months) and 3 months later
Secondary	DKEFS Word Fluency	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	Baseline, Immediately post intervention (2 months) and 3 months later
Secondary	DKEFS Trail Making- Condition 4: Number-letter Switching	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	Baseline, Immediately post intervention (2 months) and 3 months later