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OpenTrials
Completed

NCT Number: NCT01163279

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

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.

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Key information

Conditions

Aging

Age range

65 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Baycrest

Toronto, Ontario, M6A 2E1, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Adopted Cognitive Orientation to Occupational Performance (CO-OP)

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.

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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

  3. 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.

  4. 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

  5. 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

  6. 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.

  7. 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

  8. 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.

  9. 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

  10. 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

Sponsors and collaborators

Lead sponsor

Baycrest

Other

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jul 15, 2010
Registry last updated
Dec 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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