- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01163279
Maintaining Autonomy as we Age. Strategy Training for Age-related Executive Dysfunction.
November 8, 2017 updated by: Dr. Deirdre Dawson, Baycrest
Maintaining Autonomy as we Age: Investigating the Application of a Strategy Training Approach for Ameliorating the Effects of Age-related Executive Dysfunction - Part II
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
19
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M6A 2E1
- Baycrest
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years to 90 years (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cognitive Training
|
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:
|
Active Comparator: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Immediately post intervention (2 months) and 3 months later
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Baseline, Immediately post intervention (2 months) and 3 months later
|
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
|
Baseline, Immediately post intervention (2 months) and 3 months later
|
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.
|
Baseline, Immediately post intervention (2 months) and 3 months later
|
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
|
Baseline, Immediately post intervention (2 months) and 3 months later
|
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
|
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
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.
|
Baseline, Immediately post intervention (2 months) and 3 months later
|
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
|
Baseline, Immediately post intervention (2 months) and 3 months later
|
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.
|
Baseline, Immediately post intervention (2 months) and 3 months later
|
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
|
Baseline, Immediately post intervention (2 months) and 3 months later
|
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
|
Baseline, Immediately post intervention (2 months) and 3 months later
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Deirdre Dawson, PhD, Rotman Research Institute, Baycrest
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2010
Primary Completion (Actual)
October 1, 2011
Study Completion (Actual)
October 1, 2011
Study Registration Dates
First Submitted
July 14, 2010
First Submitted That Met QC Criteria
July 14, 2010
First Posted (Estimate)
July 15, 2010
Study Record Updates
Last Update Posted (Actual)
December 18, 2017
Last Update Submitted That Met QC Criteria
November 8, 2017
Last Verified
November 1, 2017
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- REB1021
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Aging
-
Tuba MadenCompletedAging | Aging Problems | Aging Disorder
-
Radboud University Medical CenterNot yet recruitingAging | Aging Well | Immuno Aging
-
University of Santiago de CompostelaEuropean Regional Development Fund; Center for Industrial Technological Development...Completed
-
TruDiagnosticBlushield USANot yet recruitingAging | Aging Well
-
San Diego State UniversityCompleted
-
Lithuanian Sports UniversityCompletedAging | Healthy AgingLithuania
-
Northumbria UniversityUniversity of East AngliaSuspendedSleep | Aging | Healthy AgingUnited Kingdom
-
Amazentis SAproDERM GmbHCompleted
-
University of West AtticaNot yet recruiting
-
University of Santiago de CompostelaAgencia Estatal de Investigación, SpainRecruiting
Clinical Trials on Real world strategy approach
-
BaycrestCompletedSubjective Cognitive DeclineCanada
-
BaycrestCompletedSubjective Cognitive DeclineCanada
-
University of North Carolina, Chapel HillAcademy of Orthopaedic Physical TherapyCompletedChronic Ankle InstabilityUnited States
-
Sun Yat-sen UniversityRecruiting
-
Wuhan Union Hospital, ChinaWuhan University; Renmin Hospital of Wuhan University; Wuhan TongJi HospitalRecruiting
-
Shanghai Zhongshan HospitalRecruitingLymphoma | Hodgkin Lymphoma | Non-hodgkin LymphomaChina
-
University of ZurichCompleted
-
Sixth Affiliated Hospital, Sun Yat-sen UniversityCompletedRespiratory Insufficiency | Postoperative Pulmonary ComplicationsChina
-
National Taiwan Normal UniversityCompletedSchizophrenia | Virtual Reality | Video Games | Multi-tasksTaiwan
-
The University of Texas at DallasCompleted