Maintaining Independence in Everyday Life Among Seniors With Subjective Cognitive Complaints

Aging Clinical Trial

Official title:

Maintaining Independence in Everyday Life Among Seniors With Subjective Cognitive Complaints

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02655497
• Other study ID #: REB#15-29
• Status: Completed
• Phase: N/A
• First received: November 17, 2015
• Last updated: November 17, 2016
• Start date: September 2015
• Est. completion date: September 2016

Study information

• Verified date: November 2016
• Source: Baycrest
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: September 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 60 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aging

Intervention

Behavioral:
• Cognitive training

• Psychosocial education

Locations

Country	Name	City	State
Canada	Baycrest Health Sciences	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Baycrest	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No