Aging
Conditions
Keywords
Age-related changes
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.
Interventions
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.
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.
Sponsors
Study design
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Number of Goals Improved to Criterion on the Canadian Occupational Performance Measure (COPM) | 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
| Measure | Time frame | Description |
|---|---|---|
| Stanford Patient Education Research Center- General Health Subscale | 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 |
| Stanford Patient Education Research Center- Health Distress Subscale | 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. |
| Stanford Patient Education Research Center- Physical Activity Subscale | 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 |
| Stanford Patient Education Research Center- Communication With Physicians Subscale | 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 |
| General Self Efficacy Scale (GSE) | 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 |
| Delis Kaplan Executive Function System (DKEFS) Tower Test- Mean First-Move Time | 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 |
| DKEFS Tower Test- Achievement Score | 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. |
| DKEFS Word Fluency | 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 |
| DKEFS Trail Making- Condition 4: Number-letter Switching | 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 |
| Stanford Patient Education Research Center- Visits to Physician and Emergency Department in the Past Six Months Subscale | 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. |
Countries
Canada
Participant flow
Recruitment details
Participants were recruited from a research subject pool and a community psycho-education program at Baycrest.
Pre-assignment details
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 by arm
| Arm | Count |
|---|---|
| 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. | 10 |
| 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. | 9 |
| Total | 19 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 2 | 0 |
Baseline characteristics
| Characteristic | Psychosocial Education | Cognitive Training | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 9 Participants | 10 Participants | 19 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 73.67 years STANDARD_DEVIATION 5.43 | 74.10 years STANDARD_DEVIATION 8.77 | 73.94 years STANDARD_DEVIATION 7.18 |
| Region of Enrollment Canada | 9 participants | 10 participants | 19 participants |
| Sex: Female, Male Female | 7 Participants | 9 Participants | 16 Participants |
| Sex: Female, Male Male | 2 Participants | 1 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 10 | 0 / 9 |
| serious Total, serious adverse events | 0 / 10 | 0 / 9 |
Outcome results
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.
Time frame: Immediately post intervention (2 months) and 3 months later
Population: Intention to treat analysis was done therefore, the analysis population includes all participants who were randomized (n=19).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cognitive Training | Total Number of Goals Improved to Criterion on the Canadian Occupational Performance Measure (COPM) | post intervention performance | 50 percentage of untrained goals improved |
| Cognitive Training | Total Number of Goals Improved to Criterion on the Canadian Occupational Performance Measure (COPM) | post intervention satisfaction | 50 percentage of untrained goals improved |
| Cognitive Training | Total Number of Goals Improved to Criterion on the Canadian Occupational Performance Measure (COPM) | 3-month follow up performance | 36.4 percentage of untrained goals improved |
| Cognitive Training | Total Number of Goals Improved to Criterion on the Canadian Occupational Performance Measure (COPM) | 3-month follow up satisfaction | 45.5 percentage of untrained goals improved |
| Psychosocial Education | Total Number of Goals Improved to Criterion on the Canadian Occupational Performance Measure (COPM) | 3-month follow up satisfaction | 28.3 percentage of untrained goals improved |
| Psychosocial Education | Total Number of Goals Improved to Criterion on the Canadian Occupational Performance Measure (COPM) | post intervention performance | 19.6 percentage of untrained goals improved |
| Psychosocial Education | Total Number of Goals Improved to Criterion on the Canadian Occupational Performance Measure (COPM) | 3-month follow up performance | 26.1 percentage of untrained goals improved |
| Psychosocial Education | Total Number of Goals Improved to Criterion on the Canadian Occupational Performance Measure (COPM) | post intervention satisfaction | 32.6 percentage of untrained goals improved |
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
Time frame: Baseline, Immediately post intervention (2 months) and 3 months later
Population: Intention to treat analysis was done therefore, the analysis population includes all participants who were randomized (n=19).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cognitive Training | Delis Kaplan Executive Function System (DKEFS) Tower Test- Mean First-Move Time | Baseline | 5.48 Time in seconds | Standard Deviation 3.72 |
| Cognitive Training | Delis Kaplan Executive Function System (DKEFS) Tower Test- Mean First-Move Time | Immediately post intervention (2 months) | 3.00 Time in seconds | Standard Deviation 1.72 |
| Cognitive Training | Delis Kaplan Executive Function System (DKEFS) Tower Test- Mean First-Move Time | 3 months post intervention | 2.47 Time in seconds | Standard Deviation 1.78 |
| Psychosocial Education | Delis Kaplan Executive Function System (DKEFS) Tower Test- Mean First-Move Time | Baseline | 6.13 Time in seconds | Standard Deviation 5.83 |
| Psychosocial Education | Delis Kaplan Executive Function System (DKEFS) Tower Test- Mean First-Move Time | Immediately post intervention (2 months) | 3.69 Time in seconds | Standard Deviation 2.89 |
| Psychosocial Education | Delis Kaplan Executive Function System (DKEFS) Tower Test- Mean First-Move Time | 3 months post intervention | 1.72 Time in seconds | Standard Deviation 0.71 |
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.
Time frame: Baseline, Immediately post intervention (2 months) and 3 months later
Population: Intention to treat analysis was done therefore, the analysis population includes all participants who were randomized (n=19).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cognitive Training | DKEFS Tower Test- Achievement Score | Baseline | 17.10 units on a scale | Standard Deviation 3.57 |
| Cognitive Training | DKEFS Tower Test- Achievement Score | Immediately post intervention (2 months) | 18.30 units on a scale | Standard Deviation 3.59 |
| Cognitive Training | DKEFS Tower Test- Achievement Score | 3 months post intervention | 20.90 units on a scale | Standard Deviation 4.31 |
| Psychosocial Education | DKEFS Tower Test- Achievement Score | Baseline | 15.78 units on a scale | Standard Deviation 4.09 |
| Psychosocial Education | DKEFS Tower Test- Achievement Score | Immediately post intervention (2 months) | 19.44 units on a scale | Standard Deviation 4.07 |
| Psychosocial Education | DKEFS Tower Test- Achievement Score | 3 months post intervention | 18.89 units on a scale | Standard Deviation 3.3 |
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
Time frame: Baseline, Immediately post intervention (2 months) and 3 months later
Population: Intention to treat analysis was done therefore, the analysis population includes all participants who were randomized (n=19).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cognitive Training | DKEFS Trail Making- Condition 4: Number-letter Switching | Baseline | 104.50 Time in seconds | Standard Deviation 43.87 |
| Cognitive Training | DKEFS Trail Making- Condition 4: Number-letter Switching | Immediately post intervention (2 months) | 88.40 Time in seconds | Standard Deviation 28.55 |
| Cognitive Training | DKEFS Trail Making- Condition 4: Number-letter Switching | 3 months post intervention | 94.10 Time in seconds | Standard Deviation 32.7 |
| Psychosocial Education | DKEFS Trail Making- Condition 4: Number-letter Switching | Baseline | 91.11 Time in seconds | Standard Deviation 19.19 |
| Psychosocial Education | DKEFS Trail Making- Condition 4: Number-letter Switching | Immediately post intervention (2 months) | 80.56 Time in seconds | Standard Deviation 25.37 |
| Psychosocial Education | DKEFS Trail Making- Condition 4: Number-letter Switching | 3 months post intervention | 84.44 Time in seconds | Standard Deviation 31.33 |
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
Time frame: Baseline, Immediately post intervention (2 months) and 3 months later
Population: Intention to treat analysis was done therefore, the analysis population includes all participants who were randomized (n=19).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cognitive Training | DKEFS Word Fluency | Baseline | 55.30 Number of words generated | Standard Deviation 15.25 |
| Cognitive Training | DKEFS Word Fluency | Immediately post intervention (2 months) | 56.40 Number of words generated | Standard Deviation 18.38 |
| Cognitive Training | DKEFS Word Fluency | 3 months post intervention | 57.40 Number of words generated | Standard Deviation 16.34 |
| Psychosocial Education | DKEFS Word Fluency | Baseline | 48.56 Number of words generated | Standard Deviation 11.74 |
| Psychosocial Education | DKEFS Word Fluency | Immediately post intervention (2 months) | 50.33 Number of words generated | Standard Deviation 9.12 |
| Psychosocial Education | DKEFS Word Fluency | 3 months post intervention | 50.11 Number of words generated | Standard Deviation 13.05 |
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
Time frame: Baseline, Immediately post intervention (2 months) and 3 months later
Population: Intention to treat analysis was done therefore, the analysis population includes all participants who were randomized (n=19).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cognitive Training | General Self Efficacy Scale (GSE) | Baseline | 29.10 Scores on scale | Standard Deviation 3.41 |
| Cognitive Training | General Self Efficacy Scale (GSE) | Immediately post intervention (2 months) | 30.90 Scores on scale | Standard Deviation 3.98 |
| Cognitive Training | General Self Efficacy Scale (GSE) | 3 months post intervention | 30.50 Scores on scale | Standard Deviation 4.12 |
| Psychosocial Education | General Self Efficacy Scale (GSE) | Baseline | 32.56 Scores on scale | Standard Deviation 3.4 |
| Psychosocial Education | General Self Efficacy Scale (GSE) | Immediately post intervention (2 months) | 33.56 Scores on scale | Standard Deviation 4.28 |
| Psychosocial Education | General Self Efficacy Scale (GSE) | 3 months post intervention | 33.56 Scores on scale | Standard Deviation 3.43 |
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
Time frame: Baseline, Immediately post intervention (2 months) and 3 months later
Population: Intention to treat analysis was done therefore, the analysis population includes all participants who were randomized (n=19).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cognitive Training | Stanford Patient Education Research Center- Communication With Physicians Subscale | Baseline | 8.40 units on a scale | Standard Deviation 3.84 |
| Cognitive Training | Stanford Patient Education Research Center- Communication With Physicians Subscale | 3 months post intervention | 10.00 units on a scale | Standard Deviation 3.8 |
| Cognitive Training | Stanford Patient Education Research Center- Communication With Physicians Subscale | Immediately post intervention (2 months) | 9.50 units on a scale | Standard Deviation 4.17 |
| Psychosocial Education | Stanford Patient Education Research Center- Communication With Physicians Subscale | Baseline | 11.00 units on a scale | Standard Deviation 3.04 |
| Psychosocial Education | Stanford Patient Education Research Center- Communication With Physicians Subscale | Immediately post intervention (2 months) | 9.11 units on a scale | Standard Deviation 3.33 |
| Psychosocial Education | Stanford Patient Education Research Center- Communication With Physicians Subscale | 3 months post intervention | 8.89 units on a scale | Standard Deviation 4.17 |
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
Time frame: Baseline, Immediately post intervention (2 months) and 3 months later
Population: Intention to treat analysis was done therefore, the analysis population includes all participants who were randomized (n=19).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cognitive Training | Stanford Patient Education Research Center- General Health Subscale | Baseline | 2.20 units on a scale | Standard Deviation 0.63 |
| Cognitive Training | Stanford Patient Education Research Center- General Health Subscale | Immediately post intervention (2 months) | 2.20 units on a scale | Standard Deviation 0.42 |
| Cognitive Training | Stanford Patient Education Research Center- General Health Subscale | 3 months post intervention | 2.20 units on a scale | Standard Deviation 0.92 |
| Psychosocial Education | Stanford Patient Education Research Center- General Health Subscale | Baseline | 1.89 units on a scale | Standard Deviation 0.78 |
| Psychosocial Education | Stanford Patient Education Research Center- General Health Subscale | Immediately post intervention (2 months) | 1.78 units on a scale | Standard Deviation 0.83 |
| Psychosocial Education | Stanford Patient Education Research Center- General Health Subscale | 3 months post intervention | 2.00 units on a scale | Standard Deviation 0.87 |
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.
Time frame: Baseline, Immediately post intervention (2 months) and 3 months later
Population: Intention to treat analysis was done therefore, the analysis population includes all participants who were randomized (n=19).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cognitive Training | Stanford Patient Education Research Center- Health Distress Subscale | Baseline | 2.70 units on a scale | Standard Deviation 2.21 |
| Cognitive Training | Stanford Patient Education Research Center- Health Distress Subscale | Immediately post intervention (2 months) | 3.80 units on a scale | Standard Deviation 3.46 |
| Cognitive Training | Stanford Patient Education Research Center- Health Distress Subscale | 3 months post intervention | 3.70 units on a scale | Standard Deviation 3.37 |
| Psychosocial Education | Stanford Patient Education Research Center- Health Distress Subscale | Baseline | 4.22 units on a scale | Standard Deviation 2.77 |
| Psychosocial Education | Stanford Patient Education Research Center- Health Distress Subscale | Immediately post intervention (2 months) | 3.67 units on a scale | Standard Deviation 4.21 |
| Psychosocial Education | Stanford Patient Education Research Center- Health Distress Subscale | 3 months post intervention | 4.11 units on a scale | Standard Deviation 2.03 |
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
Time frame: Baseline, Immediately post intervention (2 months) and 3 months later
Population: Intention to treat analysis was done therefore, the analysis population includes all participants who were randomized (n=19).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cognitive Training | Stanford Patient Education Research Center- Physical Activity Subscale | Baseline | 4.08 hours of physical activity/week | Standard Deviation 2.22 |
| Cognitive Training | Stanford Patient Education Research Center- Physical Activity Subscale | Immediately post intervention (2 months) | 4.45 hours of physical activity/week | Standard Deviation 2.53 |
| Cognitive Training | Stanford Patient Education Research Center- Physical Activity Subscale | 3 months post intervention | 4.15 hours of physical activity/week | Standard Deviation 1.83 |
| Psychosocial Education | Stanford Patient Education Research Center- Physical Activity Subscale | Baseline | 5.31 hours of physical activity/week | Standard Deviation 1.47 |
| Psychosocial Education | Stanford Patient Education Research Center- Physical Activity Subscale | Immediately post intervention (2 months) | 3.64 hours of physical activity/week | Standard Deviation 1.35 |
| Psychosocial Education | Stanford Patient Education Research Center- Physical Activity Subscale | 3 months post intervention | 3.19 hours of physical activity/week | Standard Deviation 1.56 |
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.
Time frame: Baseline, Immediately post intervention (2 months) and 3 months later
Population: Intention to treat analysis was done therefore, the analysis population includes all participants who were randomized (n=19).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cognitive Training | Stanford Patient Education Research Center- Visits to Physician and Emergency Department in the Past Six Months Subscale | Baseline | 2.30 number of visits | Standard Deviation 0.95 |
| Cognitive Training | Stanford Patient Education Research Center- Visits to Physician and Emergency Department in the Past Six Months Subscale | Immediately post intervention (2 months) | 1.50 number of visits | Standard Deviation 0.97 |
| Cognitive Training | Stanford Patient Education Research Center- Visits to Physician and Emergency Department in the Past Six Months Subscale | 3 months post intervention | 2.00 number of visits | Standard Deviation 1.24 |
| Psychosocial Education | Stanford Patient Education Research Center- Visits to Physician and Emergency Department in the Past Six Months Subscale | Baseline | 2.78 number of visits | Standard Deviation 3.07 |
| Psychosocial Education | Stanford Patient Education Research Center- Visits to Physician and Emergency Department in the Past Six Months Subscale | Immediately post intervention (2 months) | 3.33 number of visits | Standard Deviation 4 |
| Psychosocial Education | Stanford Patient Education Research Center- Visits to Physician and Emergency Department in the Past Six Months Subscale | 3 months post intervention | 2.33 number of visits | Standard Deviation 2.74 |