Preventing Cognitive and Functional Decline Among Seniors at Risk

NCT ID: NCT03495037

Last Updated: 2021-07-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 232 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-02
• Study Completion Date: 2021-03-30

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.

Conditions

Subjective Cognitive Decline

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Real World Strategy Training

Group intervention including education and strategy training to manage everyday functional difficulties.

Group Type: EXPERIMENTAL

Real World Strategy Training

Intervention Type: BEHAVIORAL

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

Group sessions including education on brain health.

Group Type: ACTIVE_COMPARATOR

Psychosocial Education

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Adopted Cognitive Orientation to Occupational Performance

Eligibility 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

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Baycrest

OTHER

Sponsor Role: lead

Responsible Party

Dr. Deirdre Dawson

Senior Scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Deirdre Dawson, PhD

Role: PRINCIPAL_INVESTIGATOR

Rotman Research Institute, Baycrest Health Sciences

Locations

Baycrest Health Sciences

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

REB1738

Identifier Type: -

Identifier Source: org_study_id