Preventing Cognitive and Functional Decline Among Seniors at Risk

Not Applicable

Completed

• Conditions: Subjective Cognitive Decline
• Interventions: Behavioral: Psychosocial Education; Behavioral: Real World Strategy Training

• Registration Number: NCT03495037
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2017-11-02
• Study First Submitted: 2018-02-22
• Study First Submitted QC: 2018-04-10
• Study First Posted: 2018-04-11
• Primary Completion: 2021-03-30
• Study Completion: 2021-03-30
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-19
• Last Update Posted: 2021-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 232

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Psychosocial Education	Psychosocial Education	Group sessions including education on brain health.
Real World Strategy Training	Real World Strategy Training	Group intervention including education and strategy training to manage everyday functional difficulties.

Primary Outcome Measures

Name	Time	Method
Changes in improved performance (measured as total number of untrained goals improved to criterion) on the Canadian Occupational Performance Measure (COPM) immediately post-intervention.	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

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

Trial Locations

Locations (1)

Baycrest Health Sciences; 🇨🇦 Toronto, Ontario, Canada