Preventing Cognitive and Functional Decline Among Seniors at Risk

Subjective Cognitive Decline Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03495037
• Other study ID #: REB1738
• Status: Completed
• Phase: N/A
• Start date: November 2, 2017
• Est. completion date: March 30, 2021

Study information

• Verified date: July 2021
• Source: Baycrest
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 232
• Est. completion date: March 30, 2021
• Est. primary completion date: March 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Subjective Cognitive Decline

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	Baycrest Health Sciences	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Baycrest

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.