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Preventing Cognitive and Functional Decline Among Seniors at Risk

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03495037
Recruitment Status : Recruiting
First Posted : April 11, 2018
Last Update Posted : July 9, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. Deirdre Dawson, Baycrest

Brief Summary:
This study evaluates the efficacy of Real-World Strategy Training (RWST) compared to a psycho-education workshop for improving everyday life performance in older adults with subjective cognitive decline (SCD). Participants will be randomly assigned to receive one of these approaches.

Condition or disease Intervention/treatment Phase
Subjective Cognitive Decline Behavioral: Real World Strategy Training Behavioral: Psychosocial Education Not Applicable

Detailed Description:

Evidence suggests that 25-50% of community-dwelling older adults report SCD and that these individuals have an elevated risk for developing Mild Cognitive Impairment and/or dementia. Many of these individuals report difficulties with complex activities of daily living.

RWST aims to reduce these difficulties in everyday life by providing a meta-cognitive training approach that compensates for age-related executive changes. The approach is provided within the context of individually identified everyday-life difficulties.

The psycho-education approach is a Brain-Health Workshop supplemented by intellectually stimulating activities such as doing Sudoku and/or word searches. This approach provides information people may use to inform health behaviour changes.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 272 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Preventing Cognitive and Functional Decline Among Seniors at Risk: A Community-Based Randomized Trial
Actual Study Start Date : November 2, 2017
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : March 2021

Arm Intervention/treatment
Experimental: Real World Strategy Training
Group intervention including education and strategy training to manage everyday functional difficulties.
Behavioral: Real World Strategy 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 Name: Adopted Cognitive Orientation to Occupational Performance

Active Comparator: Psychosocial Education
Group sessions including education on brain health.
Behavioral: 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 Sodoku puzzles. Homework will consist of reading assignments related to the session topics.




Primary Outcome Measures :
  1. Changes in improved performance (measured as total number of untrained goals improved to criterion) on the Canadian Occupational Performance Measure (COPM) immediately post-intervention. [ Time Frame: Changes from baseline to post-intervention at 10 weeks. ]
    The COPM is a standardized semi-structure interview in which participants identify everyday life difficulties (defined as things they need to or want to do). These issues are converted to goals with performance rated on a 10-point Likert-type scale. Goals considered improved to criterion are those that have a 2 or more points increase on ratings.


Secondary Outcome Measures :
  1. Improved performance on the Canadian Occupational Performance Measure (COPM) measured at three and six months post-intervention. [ Time Frame: Three and six months post-intervention. ]
    See primary outcome.

  2. Improved satisfaction with performance on trained and untrained goals identified using the COPM. [ Time Frame: 10 weeks after baseline (after intervention), 3 months post-intervention, 6 months post-intervention. ]
    Satisfaction with performance is measured on a 10-point Likert type scale using the COPM.

  3. Improved performance on the Multiple Errands Test (MET). [ Time Frame: 10 weeks after baseline (after intervention), 3 months post-intervention, 6 months post-intervention.nths post-intervention. ]
    The MET is an ecologically valid, performance measure being used to determine if strategies learned in RWST are transferred to novel contexts. Best performance is achieved through completing all tasks (n=12) without breaking any rules (n=9).

  4. Change in health-related Quality of Life [ Time Frame: Baseline, 10 weeks, 3 months post-intervention, 6 months post-intervention. ]
    Health-related quality of life will be measured using the SF-36.

  5. Improved performance on neuropsychological measures of executive function. [ Time Frame: Baseline, 10 weeks, 3 months post-intervention, 6 months post-intervention. ]
    Changes in executive function are anticipated as meta-cognitive strategy training targets the executive control system. These will be measured using the Delis-Kaplan Executive Function System.



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Ages Eligible for Study:   60 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Have subjective cognitive complaints
  • Be fluent in written and spoken English
  • Able to self-identify areas of their everyday lives in which they would like to improve.

Exclusion Criteria:

  • Diagnosis of neurological conditions (e.g. dementia, mild cognitive impairment, Parkinson's)
  • Presence of severe depression
  • Presence of substance abuse
  • History of hospitalization for psychiatric reasons

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03495037


Contacts
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Contact: Yael Bar, MSW 416-785-2500 ext 3377 ybar@research.baycrest.org

Locations
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Canada, Ontario
Baycrest Health Sciences Recruiting
Toronto, Ontario, Canada, M6A 2E1
Contact: Yael Bar, MSW    416-785-2500 ext 3377    ybar@research.baycrest.org   
Sponsors and Collaborators
Baycrest
Investigators
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Principal Investigator: Deirdre Dawson, PhD Rotman Research Institute, Baycrest Health Sciences
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Responsible Party: Dr. Deirdre Dawson, Senior Scientist, Baycrest
ClinicalTrials.gov Identifier: NCT03495037    
Other Study ID Numbers: REB1738
First Posted: April 11, 2018    Key Record Dates
Last Update Posted: July 9, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Deirdre Dawson, Baycrest:
Age-related cognitive changes
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders