Subjective Cognitive Decline Clinical Trial
Official title:
Preventing Cognitive and Functional Decline Among Seniors at Risk-Effects of Online Training Aimed at Increasing Participation in Everyday Life During a Pandemic.
Verified date | July 2021 |
Source | Baycrest |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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. Additionally, this study will provide insight into the benefits of the program while people are not able to meet in person during a pandemic.
Status | Completed |
Enrollment | 32 |
Est. completion date | March 31, 2021 |
Est. primary completion date | March 31, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 60 Years to 85 Years |
Eligibility | Inclusion Criteria: - Have access to high speed internet and a computer or mobile device with a webcam - 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 |
Country | Name | City | State |
---|---|---|---|
Canada | Baycrest Health Sciences | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
Baycrest |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in improved performance (measured as total number of untrained goals improved to criterion) on the Canadian Occupational Performance Measure (COPM) immediately post-intervention. | The COPM is a standardized semi-structure interview in which participants identify everyday life difficulties (defined as things they need to or want to do). These issues are converted to goals with performance rated on a 10-point Likert-type scale. Goals considered improved to criterion are those that have a 2 or more points increase on ratings. | Changes from baseline to post-intervention at 10 weeks | |
Secondary | Improved performance on the Canadian Occupational Performance Measure (COPM) measured at three and six months post-intervention. | Same as outcome 1. Goals considered improved to criterion are those that have a 2 or more points increase on ratings. | Three and six months post-intervention | |
Secondary | Improved satisfaction with performance on trained and untrained goals identified using the COPM. | Satisfaction with performance is measured on a 10-point Likert type scale using the Canadian Occupational Performance Measure. Goals considered improved to criterion are those that have a 2 or more points increase on ratings. | 10 weeks after baseline (after intervention), 3 months post-intervention, 6 months post-intervention | |
Secondary | Changes on Social Support Survey Instrument (MOS-SSS) | This 5-point likert type instrument measures participants' perceived availability of social support in various situations. The lowest possible score is 20 and highest possible is 100. Higher scores indicate better outcome. | Baseline, 10 weeks, 3 months post-intervention, 6 months post-intervention | |
Secondary | Changes on DeJong Gierveld Loneliness Scale | This scale measures loneliness and perceived social isolation. It will be administered to evaluate the impact of the intervention on participants' levels of self-isolation and loneliness. Lowest possible score is 0 and highest score is 6. Lower scores indicate better outcome. | Baseline, 10 weeks, 3 months post-intervention, 6 months post-intervention | |
Secondary | Changes on Lubben Social Network Scale | This 5-point likert type scale measures social isolation by measuring frequency, size, and closeness of contacts of the respondent's social network by assessing the perceived level of support they get from friends and families. Lowest possible score is 0 and highest possible score is 30. Higher scores indicate better outcome. | Baseline, 10 weeks, 3 months post-intervention, 6 months post-intervention | |
Secondary | Change in health-related Quality of Life | Health-related quality of life will be measured using the Short From Health Survey (SF-36). This survey includes the following sub scales (higher scores on each sub-scale indicate better outcome):
Physical functioning with lowest possible score being 10 and highest 30; Role functioning with lowest possible score of 4 and highest 8; Bodily pain with lowest possible score of 2 and highest of 12; General health with lowest possible score of 5 and highest of 25; Vitality with lowest possible score of 4 and highest of 24; Social functioning with lowest possible score of 2 and highest of 10; Role-emotional with lowest possible score of 3 and highest of 6; Mental health with lowest possible score of 5 and highest of 30. |
Baseline, 10 weeks, 3 months post-intervention, 6 months post-intervention |
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