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

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

    • Ontario
      • Toronto, Ontario, Canada, M6A 2E1
        • Baycrest Health Sciences

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.
8 weeks after pretest and 3 months after intervention finished

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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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