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Preventing Cognitive and Functional Decline Among Seniors at Risk

Primary Purpose

Subjective Cognitive Decline

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Real World Strategy Training
Psychosocial Education
Sponsored by
Baycrest
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Subjective Cognitive Decline focused on measuring Age-related cognitive changes

Eligibility Criteria

60 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Baycrest Health Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Real World Strategy Training

Psychosocial Education

Arm Description

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

Group sessions including education on brain health.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Improved performance on the Canadian Occupational Performance Measure (COPM) measured at three and six months post-intervention.
See primary outcome.
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.
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).
Change in health-related Quality of Life
Health-related quality of life will be measured using the SF-36.
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.

Full Information

First Posted
February 22, 2018
Last Updated
July 19, 2021
Sponsor
Baycrest
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1. Study Identification

Unique Protocol Identification Number
NCT03495037
Brief Title
Preventing Cognitive and Functional Decline Among Seniors at Risk
Official Title
Preventing Cognitive and Functional Decline Among Seniors at Risk: A Community-Based Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
November 2, 2017 (Actual)
Primary Completion Date
March 30, 2021 (Actual)
Study Completion Date
March 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baycrest

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subjective Cognitive Decline
Keywords
Age-related cognitive changes

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
232 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Real World Strategy Training
Arm Type
Experimental
Arm Description
Group intervention including education and strategy training to manage everyday functional difficulties.
Arm Title
Psychosocial Education
Arm Type
Active Comparator
Arm Description
Group sessions including education on brain health.
Intervention Type
Behavioral
Intervention Name(s)
Real World Strategy Training
Other Intervention Name(s)
Adopted Cognitive Orientation to Occupational Performance
Intervention Description
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
Intervention Name(s)
Psychosocial Education
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in improved performance (measured as total number of untrained goals improved to criterion) on the Canadian Occupational Performance Measure (COPM) immediately post-intervention.
Description
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.
Time Frame
Changes from baseline to post-intervention at 10 weeks.
Secondary Outcome Measure Information:
Title
Improved performance on the Canadian Occupational Performance Measure (COPM) measured at three and six months post-intervention.
Description
See primary outcome.
Time Frame
Three and six months post-intervention.
Title
Improved satisfaction with performance on trained and untrained goals identified using the COPM.
Description
Satisfaction with performance is measured on a 10-point Likert type scale using the COPM.
Time Frame
10 weeks after baseline (after intervention), 3 months post-intervention, 6 months post-intervention.
Title
Improved performance on the Multiple Errands Test (MET).
Description
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).
Time Frame
10 weeks after baseline (after intervention), 3 months post-intervention, 6 months post-intervention.nths post-intervention.
Title
Change in health-related Quality of Life
Description
Health-related quality of life will be measured using the SF-36.
Time Frame
Baseline, 10 weeks, 3 months post-intervention, 6 months post-intervention.
Title
Improved performance on neuropsychological measures of executive function.
Description
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.
Time Frame
Baseline, 10 weeks, 3 months post-intervention, 6 months post-intervention.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deirdre Dawson, PhD
Organizational Affiliation
Rotman Research Institute, Baycrest Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baycrest Health Sciences
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6A 2E1
Country
Canada

12. IPD Sharing Statement

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Preventing Cognitive and Functional Decline Among Seniors at Risk

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