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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive Training | Experimental |
| |
| Psychosocial Education | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Stanford Patient Education Research Center- General Health Subscale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Deirdre Dawson, PhD | Rotman Research Institute, Baycrest | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baycrest | Toronto | Ontario | M6A 2E1 | Canada |
A total of 96 participants were assessed for study eligibility. 60 participants were excluded after a phone screening interview and 17 were excluded after a more detailed baseline assessment which included cognitive paper and pencil tasks. The remaining 19 participants were randomized to either the experimental arm or the control arm.
Participants were recruited from a research subject pool and a community psycho-education program at Baycrest.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cogntive Training | 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. |
| FG001 | Psychosocial Education | The active comparator was an information-based format and is designed to engage participants without providing any specific training techniques or strategies. During weekly sessions, participants received factual information on brain structure and function, age-related cognitive changes, and general brain health issues and spent time doing non-specific cognitive exercises including crossword and Sudoku puzzles. Homework consisted of reading assignments related to the session topics. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Cognitive Training | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Intention to treat analysis was done therefore, the analysis population includes all participants who were randomized (n=19). | Posted | Number | percentage of untrained goals improved | Immediately post intervention (2 months) and 3 months later | Total number of goals | Total number of goals |
|
2 months-during the intervention phase of the study
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cognitive Training | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Deirdre Dawson | Baycrest Health Sciences | 416-785-2500 | 2136 | ddawson@research.baycrest.org |
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| 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. |
|
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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 | 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. |
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| 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 | Intention to treat analysis was done therefore, the analysis population includes all participants who were randomized (n=19). | Posted | Mean | Standard Deviation | Scores on scale | Baseline, Immediately post intervention (2 months) and 3 months later |
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| 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 | Intention to treat analysis was done therefore, the analysis population includes all participants who were randomized (n=19). | Posted | Mean | Standard Deviation | units on a scale | Baseline, Immediately post intervention (2 months) and 3 months later |
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| 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. | Intention to treat analysis was done therefore, the analysis population includes all participants who were randomized (n=19). | Posted | Mean | Standard Deviation | units on a scale | Baseline, Immediately post intervention (2 months) and 3 months later |
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| 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 | Intention to treat analysis was done therefore, the analysis population includes all participants who were randomized (n=19). | Posted | Mean | Standard Deviation | hours of physical activity/week | Baseline, Immediately post intervention (2 months) and 3 months later |
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| 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 | Intention to treat analysis was done therefore, the analysis population includes all participants who were randomized (n=19). | Posted | Mean | Standard Deviation | units on a scale | Baseline, Immediately post intervention (2 months) and 3 months later |
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| 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. | Intention to treat analysis was done therefore, the analysis population includes all participants who were randomized (n=19). | Posted | Mean | Standard Deviation | number of visits | Baseline, Immediately post intervention (2 months) and 3 months later |
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| 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 | Intention to treat analysis was done therefore, the analysis population includes all participants who were randomized (n=19). | Posted | Mean | Standard Deviation | Time in seconds | Baseline, Immediately post intervention (2 months) and 3 months later |
|
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| 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. | Intention to treat analysis was done therefore, the analysis population includes all participants who were randomized (n=19). | Posted | Mean | Standard Deviation | units on a scale | Baseline, Immediately post intervention (2 months) and 3 months later |
|
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| 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 | Intention to treat analysis was done therefore, the analysis population includes all participants who were randomized (n=19). | Posted | Mean | Standard Deviation | Number of words generated | Baseline, Immediately post intervention (2 months) and 3 months later |
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| 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 | Intention to treat analysis was done therefore, the analysis population includes all participants who were randomized (n=19). | Posted | Mean | Standard Deviation | Time in seconds | Baseline, Immediately post intervention (2 months) and 3 months later |
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| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Psychosocial Education | 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. | 0 | 9 | 0 | 9 |
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| 3 months post intervention |
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| 3 months post intervention |
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| 3 months post intervention |
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| 3 months post intervention |
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| 3 months post intervention |
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Statistical analysis applies to 3 months post intervention category |
| Superiority or Other |
| 3 months post intervention |
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Statistical analysis applies to 3 months post intervention category |
| Superiority or Other |
| 3 months post intervention |
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Statistical analysis applies to 3 months post intervention category |
| Superiority or Other |
| 3 months post intervention |
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| 3 months post intervention |
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Statistical analysis applies to 3 months post intervention category |
| Superiority or Other |
| 3 months post intervention |
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