Maintaining Independence in Everyday Life Among Seniors With Subjective Cognitive Complaints
1 other identifier
interventional
16
1 country
1
Brief Summary
The purpose of this study is to determine the effectiveness of cognitive strategies in improving participation in daily activities within older adults who report subjective cognitive decline.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2015
CompletedFirst Submitted
Initial submission to the registry
November 17, 2015
CompletedFirst Posted
Study publicly available on registry
January 14, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2016
CompletedNovember 18, 2016
November 1, 2016
11 months
November 17, 2015
November 17, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Change in the Canadian Occupational Performance Measure (COPM) scores
The Canadian Occupational Performance Measure (COPM) is the primary outcome measure. All participants will identify five everyday life activities that they need to or want to do using the COPM. The primary outcome will be (a) the number of goals improved by two points.
8 weeks after pretest and 3 months after intervention finished
Study Arms (2)
Cognitive Training
EXPERIMENTALCognitive training intervention. The intervention includes seven 2-hour group sessions interspersed with four individual 45-minute sessions for a total of 17 hours of intervention over an 8-week period. The experimental group will receive real-world strategy training, a cognitive strategy based approach that trains people to improve their level of independence on meaningful activities of daily life with which they are having difficulty.
Psychosocial education
ACTIVE COMPARATORThe intervention includes seven 2-hour group sessions interspersed with four individual 45-minute sessions for a total of 17 hours of intervention over an 8-week period. The control group will receive brain-health education.
Interventions
Eligibility Criteria
You may qualify if:
- Community-dwelling older adults aged 60+
- Fluent in written and spoken English
- Have subjective cognitive complaints (SCC)
- Performance within normal limits on a neuropsychological assessment battery
- Participants must also be able to self-identify specific areas of difficulty in their everyday life that they would like to improve
You may not qualify if:
- Significant neurological or psychiatric history (e.g., multiple sclerosis, psychiatric illness requiring hospitalization)
- Concurrent depression
- Anaesthesia in previous 6 months; and substance abuse
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Baycrestlead
- Canadian Institutes of Health Research (CIHR)collaborator
Study Sites (1)
Baycrest Health Sciences
Toronto, Ontario, M6A 2E1, Canada
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Deirdre Dawson, PhD
Baycrest Health Sciences
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior Scientist
Study Record Dates
First Submitted
November 17, 2015
First Posted
January 14, 2016
Study Start
September 1, 2015
Primary Completion
August 1, 2016
Study Completion
September 1, 2016
Last Updated
November 18, 2016
Record last verified: 2016-11