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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01163279
First Posted: July 15, 2010
Last Update Posted: January 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Dr. Deirdre Dawson, Baycrest
Results First Submitted: January 12, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor)
Condition: Aging
Interventions: Behavioral: Real world strategy approach
Behavioral: Psychosocial Education

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were recruited from a research subject pool and a community psycho-education program at Baycrest.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
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.
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.

Participant Flow:   Overall Study
    Cogntive Training   Psychosocial Education
STARTED   10   9 
COMPLETED   8   9 
NOT COMPLETED   2   0 
Withdrawal by Subject                2                0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.
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.
Total Total of all reporting groups

Baseline Measures
   Cognitive Training   Psychosocial Education   Total 
Overall Participants Analyzed 
[Units: Participants]
 10   9   19 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      0   0.0%      0   0.0%      0   0.0% 
>=65 years      10 100.0%      9 100.0%      19 100.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 74.10  (8.77)   73.67  (5.43)   73.94  (7.18) 
Gender 
[Units: Participants]
Count of Participants
     
Female      9  90.0%      7  77.8%      16  84.2% 
Male      1  10.0%      2  22.2%      3  15.8% 
Region of Enrollment 
[Units: Participants]
     
Canada   10   9   19 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   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 ]

2.  Secondary:   General Self Efficacy Scale (GSE)   [ Time Frame: Baseline, Immediately post intervention (2 months) and 3 months later ]

3.  Secondary:   Stanford Patient Education Research Center- General Health Subscale   [ Time Frame: Baseline, Immediately post intervention (2 months) and 3 months later ]

4.  Secondary:   Stanford Patient Education Research Center- Health Distress Subscale   [ Time Frame: Baseline, Immediately post intervention (2 months) and 3 months later ]

5.  Secondary:   Stanford Patient Education Research Center- Physical Activity Subscale   [ Time Frame: Baseline, Immediately post intervention (2 months) and 3 months later ]

6.  Secondary:   Stanford Patient Education Research Center- Communication With Physicians Subscale   [ Time Frame: Baseline, Immediately post intervention (2 months) and 3 months later ]

7.  Secondary:   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 ]

8.  Secondary:   Delis Kaplan Executive Function System (DKEFS) Tower Test- Mean First-Move Time   [ Time Frame: Baseline, Immediately post intervention (2 months) and 3 months later ]

9.  Secondary:   DKEFS Tower Test- Achievement Score   [ Time Frame: Baseline, Immediately post intervention (2 months) and 3 months later ]

10.  Secondary:   DKEFS Word Fluency   [ Time Frame: Baseline, Immediately post intervention (2 months) and 3 months later ]

11.  Secondary:   DKEFS Trail Making- Condition 4: Number-letter Switching   [ Time Frame: Baseline, Immediately post intervention (2 months) and 3 months later ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Deirdre Dawson
Organization: Baycrest Health Sciences
phone: 416-785-2500 ext 2136
e-mail: ddawson@research.baycrest.org



Responsible Party: Dr. Deirdre Dawson, Baycrest
ClinicalTrials.gov Identifier: NCT01163279     History of Changes
Other Study ID Numbers: REB1021
First Submitted: July 14, 2010
First Posted: July 15, 2010
Results First Submitted: January 12, 2016
Results First Posted: January 12, 2017
Last Update Posted: January 12, 2017