- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02655497
Maintaining Independence in Everyday Life Among Seniors With Subjective Cognitive Complaints
November 17, 2016 updated by: Dr. Deirdre Dawson, Baycrest
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The planned project explores the effects of several interventions designed to promote independence in everyday life, with older adults who identify cognitive complaints.
Evidence suggests that 25-50% of community dwelling older adults report cognitive difficulties, such as reduced memory or concentration, in the absence of any diagnosed condition.
Cognitive skills are crucial to living independently.
The investigators plan to examine two approaches in a randomized controlled trial.
Based on our successful pilot study, the investigators hypothesize that this training which combines education on healthy lifestyles and problem solving training to address everyday life difficulties, will be effective in maximizing and maintaining independence of older adults.
Study Type
Interventional
Enrollment (Actual)
16
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Ontario
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Toronto, Ontario, Canada, M6A 2E1
- Baycrest Health Sciences
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Significant neurological or psychiatric history (e.g., multiple sclerosis, psychiatric illness requiring hospitalization)
- Concurrent depression
- Anaesthesia in previous 6 months; and substance abuse
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cognitive Training
Cognitive 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.
|
|
Active Comparator: Psychosocial education
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 control group will receive brain-health education.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in the Canadian Occupational Performance Measure (COPM) scores
Time Frame: 8 weeks after pretest and 3 months after intervention finished
|
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.
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8 weeks after pretest and 3 months after intervention finished
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Deirdre Dawson, PhD, Baycrest Health Sciences
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2015
Primary Completion (Actual)
August 1, 2016
Study Completion (Actual)
September 1, 2016
Study Registration Dates
First Submitted
November 17, 2015
First Submitted That Met QC Criteria
January 13, 2016
First Posted (Estimate)
January 14, 2016
Study Record Updates
Last Update Posted (Estimate)
November 18, 2016
Last Update Submitted That Met QC Criteria
November 17, 2016
Last Verified
November 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- REB#15-29
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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