Preventing Cognitive and Functional Decline Among Seniors at Risk

NCT03495037 | Completed

• 1 other identifier: REB1738
• Study Type: interventional
• Target: 232
• Locations: 1 country
• Sites: 1

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.

Conditions

Subjective Cognitive Decline

Keywords

Age-related cognitive changes

Outcome Measures

Primary Outcomes (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.

  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 Outcomes (5)

• Improved performance on the Canadian Occupational Performance Measure (COPM) measured at three and six months post-intervention.

  Three and six months post-intervention.

• 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.

• 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.

• Change in health-related Quality of Life

  Baseline, 10 weeks, 3 months post-intervention, 6 months post-intervention.

• Improved performance on neuropsychological measures of executive function.

  Baseline, 10 weeks, 3 months post-intervention, 6 months post-intervention.

Study Arms (2)

Real World Strategy Training

EXPERIMENTAL

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

Behavioral: Real World Strategy Training

Psychosocial Education

ACTIVE COMPARATOR

Group sessions including education on brain health.

Behavioral: Psychosocial Education

Interventions

Real World Strategy Training 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.

Also known as: Adopted Cognitive Orientation to Occupational Performance

Real World Strategy Training

Psychosocial Education 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.

Psychosocial Education

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Baycrest: lead

Study Sites (1)

Baycrest Health Sciences

Toronto, Ontario, M6A 2E1, Canada

Location

Study Officials

• Deirdre Dawson, PhD

  Rotman Research Institute, Baycrest Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Scientist

Study Record Dates

• First Submitted: February 22, 2018
• First Posted: April 11, 2018
• Study Start: November 2, 2017
• Primary Completion: March 30, 2021
• Study Completion: March 30, 2021
• Last Updated: July 21, 2021

Record last verified: 2021-07

Locations

CA (1)