Clinical trial NCT03495037: 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
Overall status: COMPLETED
Phase: NA
Conditions: Subjective Cognitive Decline
Keywords: Age-related cognitive changes
Lead sponsor: Baycrest
Sponsor class: OTHER
First posted: 2018-04-11
Enrollment: 232
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Changes in improved performance (measured as total number of untrained goals improved to criterion) on the Canadian Occupational Performance Measure (COPM) immediately post-intervention.
timeFrame: Changes from baseline to post-intervention at 10 weeks.
Secondary outcomes:
measure: Improved performance on the Canadian Occupational Performance Measure (COPM) measured at three and six months post-intervention.
timeFrame: Three and six months post-intervention.
measure: Improved satisfaction with performance on trained and untrained goals identified using the COPM.
timeFrame: 10 weeks after baseline (after intervention), 3 months post-intervention, 6 months post-intervention.
measure: Improved performance on the Multiple Errands Test (MET).
timeFrame: 10 weeks after baseline (after intervention), 3 months post-intervention, 6 months post-intervention.nths post-intervention.
measure: Change in health-related Quality of Life
timeFrame: Baseline, 10 weeks, 3 months post-intervention, 6 months post-intervention.
measure: Improved performance on neuropsychological measures of executive function.
timeFrame: Baseline, 10 weeks, 3 months post-intervention, 6 months post-intervention.
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Baycrest Health Sciences
state: Ontario
Study officials:
affiliation: Rotman Research Institute, Baycrest Health Sciences
name: Deirdre Dawson, PhD
role: PRINCIPAL_INVESTIGATOR
References: