Preventing Cognitive and Functional Decline Among Seniors at Risk

Preventing Cognitive and Functional Decline Among Seniors at Risk: A Community-Based Randomized Trial

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.

Study Overview

• Status: Completed
• Conditions: Subjective Cognitive Decline
• Intervention / Treatment: Behavioral: Real World Strategy Training; Behavioral: Psychosocial Education

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.

• Study Type: Interventional
• Enrollment (Actual): 232
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M6A 2E1
      • Baycrest Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in improved performance (measured as total number of untrained goals improved to criterion) on the Canadian Occupational Performance Measure (COPM) immediately post-intervention.	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.	Changes from baseline to post-intervention at 10 weeks.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improved performance on the Canadian Occupational Performance Measure (COPM) measured at three and six months post-intervention.	See primary outcome.	Three and six months post-intervention.
Improved satisfaction with performance on trained and untrained goals identified using the COPM.	Satisfaction with performance is measured on a 10-point Likert type scale using the COPM.	10 weeks after baseline (after intervention), 3 months post-intervention, 6 months post-intervention.
Improved performance on the Multiple Errands Test (MET).	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).	10 weeks after baseline (after intervention), 3 months post-intervention, 6 months post-intervention.nths post-intervention.
Change in health-related Quality of Life	Health-related quality of life will be measured using the SF-36.	Baseline, 10 weeks, 3 months post-intervention, 6 months post-intervention.
Improved performance on neuropsychological measures of executive function.	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.	Baseline, 10 weeks, 3 months post-intervention, 6 months post-intervention.

Collaborators and Investigators

• Sponsor: Baycrest

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 2, 2017
• Primary Completion (ACTUAL): March 30, 2021
• Study Completion (ACTUAL): March 30, 2021

Study Registration Dates

• First Submitted: February 22, 2018
• First Submitted That Met QC Criteria: April 10, 2018
• First Posted (ACTUAL): April 11, 2018

Study Record Updates

• Last Update Posted (ACTUAL): July 21, 2021
• Last Update Submitted That Met QC Criteria: July 19, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Age-related cognitive changes
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: REB1738

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No