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

Maintaining Autonomy as we Age: Investigating the Application of a Strategy Training Approach for Ameliorating the Effects of Age-related Executive Dysfunction - Part II

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01163279
Enrollment
19
Registered
2010-07-15
Start date
2010-08-31
Completion date
2011-10-31
Last updated
2017-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aging

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

BEHAVIORALReal 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.

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

Baycrest
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
65 Years to 90 Years
Healthy volunteers
Yes

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

MeasureTime frameDescription
Total Number of Goals Improved to Criterion on the Canadian Occupational Performance Measure (COPM)Immediately post intervention (2 months) and 3 months laterCOPM 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

MeasureTime frameDescription
Stanford Patient Education Research Center- General Health SubscaleBaseline, Immediately post intervention (2 months) and 3 months laterStanford 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 SubscaleBaseline, Immediately post intervention (2 months) and 3 months laterStanford 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 SubscaleBaseline, Immediately post intervention (2 months) and 3 months laterStanford 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 SubscaleBaseline, Immediately post intervention (2 months) and 3 months laterStanford 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 laterGSE 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 TimeBaseline, Immediately post intervention (2 months) and 3 months laterThis 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 ScoreBaseline, Immediately post intervention (2 months) and 3 months laterThis 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 FluencyBaseline, Immediately post intervention (2 months) and 3 months laterThis 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 SwitchingBaseline, Immediately post intervention (2 months) and 3 months laterDKEFS 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 SubscaleBaseline, Immediately post intervention (2 months) and 3 months laterStanford 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

ArmCount
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
Total19

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyWithdrawal by Subject20

Baseline characteristics

CharacteristicPsychosocial EducationCognitive TrainingTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
9 Participants10 Participants19 Participants
Age, Categorical
Between 18 and 65 years
0 Participants0 Participants0 Participants
Age, Continuous73.67 years
STANDARD_DEVIATION 5.43
74.10 years
STANDARD_DEVIATION 8.77
73.94 years
STANDARD_DEVIATION 7.18
Region of Enrollment
Canada
9 participants10 participants19 participants
Sex: Female, Male
Female
7 Participants9 Participants16 Participants
Sex: Female, Male
Male
2 Participants1 Participants3 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 100 / 9
serious
Total, serious adverse events
0 / 100 / 9

Outcome results

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.

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).

ArmMeasureGroupValue (NUMBER)
Cognitive TrainingTotal Number of Goals Improved to Criterion on the Canadian Occupational Performance Measure (COPM)post intervention performance50 percentage of untrained goals improved
Cognitive TrainingTotal Number of Goals Improved to Criterion on the Canadian Occupational Performance Measure (COPM)post intervention satisfaction50 percentage of untrained goals improved
Cognitive TrainingTotal Number of Goals Improved to Criterion on the Canadian Occupational Performance Measure (COPM)3-month follow up performance36.4 percentage of untrained goals improved
Cognitive TrainingTotal Number of Goals Improved to Criterion on the Canadian Occupational Performance Measure (COPM)3-month follow up satisfaction45.5 percentage of untrained goals improved
Psychosocial EducationTotal Number of Goals Improved to Criterion on the Canadian Occupational Performance Measure (COPM)3-month follow up satisfaction28.3 percentage of untrained goals improved
Psychosocial EducationTotal Number of Goals Improved to Criterion on the Canadian Occupational Performance Measure (COPM)post intervention performance19.6 percentage of untrained goals improved
Psychosocial EducationTotal Number of Goals Improved to Criterion on the Canadian Occupational Performance Measure (COPM)3-month follow up performance26.1 percentage of untrained goals improved
Psychosocial EducationTotal Number of Goals Improved to Criterion on the Canadian Occupational Performance Measure (COPM)post intervention satisfaction32.6 percentage of untrained goals improved
p-value: 0.03Chi-squared
p-value: 0.32Chi-squared
p-value: 0.54Chi-squared
p-value: 0.26Chi-squared
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

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).

ArmMeasureGroupValue (MEAN)Dispersion
Cognitive TrainingDelis Kaplan Executive Function System (DKEFS) Tower Test- Mean First-Move TimeBaseline5.48 Time in secondsStandard Deviation 3.72
Cognitive TrainingDelis Kaplan Executive Function System (DKEFS) Tower Test- Mean First-Move TimeImmediately post intervention (2 months)3.00 Time in secondsStandard Deviation 1.72
Cognitive TrainingDelis Kaplan Executive Function System (DKEFS) Tower Test- Mean First-Move Time3 months post intervention2.47 Time in secondsStandard Deviation 1.78
Psychosocial EducationDelis Kaplan Executive Function System (DKEFS) Tower Test- Mean First-Move TimeBaseline6.13 Time in secondsStandard Deviation 5.83
Psychosocial EducationDelis Kaplan Executive Function System (DKEFS) Tower Test- Mean First-Move TimeImmediately post intervention (2 months)3.69 Time in secondsStandard Deviation 2.89
Psychosocial EducationDelis Kaplan Executive Function System (DKEFS) Tower Test- Mean First-Move Time3 months post intervention1.72 Time in secondsStandard Deviation 0.71
p-value: <0.1ANOVA
p-value: <0.05ANOVA
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.

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).

ArmMeasureGroupValue (MEAN)Dispersion
Cognitive TrainingDKEFS Tower Test- Achievement ScoreBaseline17.10 units on a scaleStandard Deviation 3.57
Cognitive TrainingDKEFS Tower Test- Achievement ScoreImmediately post intervention (2 months)18.30 units on a scaleStandard Deviation 3.59
Cognitive TrainingDKEFS Tower Test- Achievement Score3 months post intervention20.90 units on a scaleStandard Deviation 4.31
Psychosocial EducationDKEFS Tower Test- Achievement ScoreBaseline15.78 units on a scaleStandard Deviation 4.09
Psychosocial EducationDKEFS Tower Test- Achievement ScoreImmediately post intervention (2 months)19.44 units on a scaleStandard Deviation 4.07
Psychosocial EducationDKEFS Tower Test- Achievement Score3 months post intervention18.89 units on a scaleStandard Deviation 3.3
p-value: <0.05ANOVA
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

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).

ArmMeasureGroupValue (MEAN)Dispersion
Cognitive TrainingDKEFS Trail Making- Condition 4: Number-letter SwitchingBaseline104.50 Time in secondsStandard Deviation 43.87
Cognitive TrainingDKEFS Trail Making- Condition 4: Number-letter SwitchingImmediately post intervention (2 months)88.40 Time in secondsStandard Deviation 28.55
Cognitive TrainingDKEFS Trail Making- Condition 4: Number-letter Switching3 months post intervention94.10 Time in secondsStandard Deviation 32.7
Psychosocial EducationDKEFS Trail Making- Condition 4: Number-letter SwitchingBaseline91.11 Time in secondsStandard Deviation 19.19
Psychosocial EducationDKEFS Trail Making- Condition 4: Number-letter SwitchingImmediately post intervention (2 months)80.56 Time in secondsStandard Deviation 25.37
Psychosocial EducationDKEFS Trail Making- Condition 4: Number-letter Switching3 months post intervention84.44 Time in secondsStandard Deviation 31.33
p-value: >0.05ANOVA
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

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).

ArmMeasureGroupValue (MEAN)Dispersion
Cognitive TrainingDKEFS Word FluencyBaseline55.30 Number of words generatedStandard Deviation 15.25
Cognitive TrainingDKEFS Word FluencyImmediately post intervention (2 months)56.40 Number of words generatedStandard Deviation 18.38
Cognitive TrainingDKEFS Word Fluency3 months post intervention57.40 Number of words generatedStandard Deviation 16.34
Psychosocial EducationDKEFS Word FluencyBaseline48.56 Number of words generatedStandard Deviation 11.74
Psychosocial EducationDKEFS Word FluencyImmediately post intervention (2 months)50.33 Number of words generatedStandard Deviation 9.12
Psychosocial EducationDKEFS Word Fluency3 months post intervention50.11 Number of words generatedStandard Deviation 13.05
p-value: >0.05ANOVA
p-value: <0.05ANOVA
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

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).

ArmMeasureGroupValue (MEAN)Dispersion
Cognitive TrainingGeneral Self Efficacy Scale (GSE)Baseline29.10 Scores on scaleStandard Deviation 3.41
Cognitive TrainingGeneral Self Efficacy Scale (GSE)Immediately post intervention (2 months)30.90 Scores on scaleStandard Deviation 3.98
Cognitive TrainingGeneral Self Efficacy Scale (GSE)3 months post intervention30.50 Scores on scaleStandard Deviation 4.12
Psychosocial EducationGeneral Self Efficacy Scale (GSE)Baseline32.56 Scores on scaleStandard Deviation 3.4
Psychosocial EducationGeneral Self Efficacy Scale (GSE)Immediately post intervention (2 months)33.56 Scores on scaleStandard Deviation 4.28
Psychosocial EducationGeneral Self Efficacy Scale (GSE)3 months post intervention33.56 Scores on scaleStandard Deviation 3.43
p-value: <0.05ANOVA
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

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).

ArmMeasureGroupValue (MEAN)Dispersion
Cognitive TrainingStanford Patient Education Research Center- Communication With Physicians SubscaleBaseline8.40 units on a scaleStandard Deviation 3.84
Cognitive TrainingStanford Patient Education Research Center- Communication With Physicians Subscale3 months post intervention10.00 units on a scaleStandard Deviation 3.8
Cognitive TrainingStanford Patient Education Research Center- Communication With Physicians SubscaleImmediately post intervention (2 months)9.50 units on a scaleStandard Deviation 4.17
Psychosocial EducationStanford Patient Education Research Center- Communication With Physicians SubscaleBaseline11.00 units on a scaleStandard Deviation 3.04
Psychosocial EducationStanford Patient Education Research Center- Communication With Physicians SubscaleImmediately post intervention (2 months)9.11 units on a scaleStandard Deviation 3.33
Psychosocial EducationStanford Patient Education Research Center- Communication With Physicians Subscale3 months post intervention8.89 units on a scaleStandard Deviation 4.17
p-value: <0.1ANOVA
p-value: <0.05ANOVA
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

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).

ArmMeasureGroupValue (MEAN)Dispersion
Cognitive TrainingStanford Patient Education Research Center- General Health SubscaleBaseline2.20 units on a scaleStandard Deviation 0.63
Cognitive TrainingStanford Patient Education Research Center- General Health SubscaleImmediately post intervention (2 months)2.20 units on a scaleStandard Deviation 0.42
Cognitive TrainingStanford Patient Education Research Center- General Health Subscale3 months post intervention2.20 units on a scaleStandard Deviation 0.92
Psychosocial EducationStanford Patient Education Research Center- General Health SubscaleBaseline1.89 units on a scaleStandard Deviation 0.78
Psychosocial EducationStanford Patient Education Research Center- General Health SubscaleImmediately post intervention (2 months)1.78 units on a scaleStandard Deviation 0.83
Psychosocial EducationStanford Patient Education Research Center- General Health Subscale3 months post intervention2.00 units on a scaleStandard Deviation 0.87
p-value: >0.05ANOVA
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.

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).

ArmMeasureGroupValue (MEAN)Dispersion
Cognitive TrainingStanford Patient Education Research Center- Health Distress SubscaleBaseline2.70 units on a scaleStandard Deviation 2.21
Cognitive TrainingStanford Patient Education Research Center- Health Distress SubscaleImmediately post intervention (2 months)3.80 units on a scaleStandard Deviation 3.46
Cognitive TrainingStanford Patient Education Research Center- Health Distress Subscale3 months post intervention3.70 units on a scaleStandard Deviation 3.37
Psychosocial EducationStanford Patient Education Research Center- Health Distress SubscaleBaseline4.22 units on a scaleStandard Deviation 2.77
Psychosocial EducationStanford Patient Education Research Center- Health Distress SubscaleImmediately post intervention (2 months)3.67 units on a scaleStandard Deviation 4.21
Psychosocial EducationStanford Patient Education Research Center- Health Distress Subscale3 months post intervention4.11 units on a scaleStandard Deviation 2.03
p-value: >0.05ANOVA
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

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).

ArmMeasureGroupValue (MEAN)Dispersion
Cognitive TrainingStanford Patient Education Research Center- Physical Activity SubscaleBaseline4.08 hours of physical activity/weekStandard Deviation 2.22
Cognitive TrainingStanford Patient Education Research Center- Physical Activity SubscaleImmediately post intervention (2 months)4.45 hours of physical activity/weekStandard Deviation 2.53
Cognitive TrainingStanford Patient Education Research Center- Physical Activity Subscale3 months post intervention4.15 hours of physical activity/weekStandard Deviation 1.83
Psychosocial EducationStanford Patient Education Research Center- Physical Activity SubscaleBaseline5.31 hours of physical activity/weekStandard Deviation 1.47
Psychosocial EducationStanford Patient Education Research Center- Physical Activity SubscaleImmediately post intervention (2 months)3.64 hours of physical activity/weekStandard Deviation 1.35
Psychosocial EducationStanford Patient Education Research Center- Physical Activity Subscale3 months post intervention3.19 hours of physical activity/weekStandard Deviation 1.56
p-value: <0.05ANOVA
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.

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).

ArmMeasureGroupValue (MEAN)Dispersion
Cognitive TrainingStanford Patient Education Research Center- Visits to Physician and Emergency Department in the Past Six Months SubscaleBaseline2.30 number of visitsStandard Deviation 0.95
Cognitive TrainingStanford Patient Education Research Center- Visits to Physician and Emergency Department in the Past Six Months SubscaleImmediately post intervention (2 months)1.50 number of visitsStandard Deviation 0.97
Cognitive TrainingStanford Patient Education Research Center- Visits to Physician and Emergency Department in the Past Six Months Subscale3 months post intervention2.00 number of visitsStandard Deviation 1.24
Psychosocial EducationStanford Patient Education Research Center- Visits to Physician and Emergency Department in the Past Six Months SubscaleBaseline2.78 number of visitsStandard Deviation 3.07
Psychosocial EducationStanford Patient Education Research Center- Visits to Physician and Emergency Department in the Past Six Months SubscaleImmediately post intervention (2 months)3.33 number of visitsStandard Deviation 4
Psychosocial EducationStanford Patient Education Research Center- Visits to Physician and Emergency Department in the Past Six Months Subscale3 months post intervention2.33 number of visitsStandard Deviation 2.74
p-value: <0.05ANOVA
p-value: >0.05ANOVA

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026