Trial Outcomes & Findings for Increasing the Winter Community Participation of Older Adult Wheelchair Users (NCT NCT02622828)
NCT ID: NCT02622828
Last Updated: 2019-10-04
Results Overview
The Canadian Occupational Performance Measure (COPM) is a client-centered outcome measure designed to detect changes in performance and satisfaction in occupations that the individual has self-identified as being important and difficult to perform. The COPM has well-established psychometric properties and will be used as the primary outcome measure and will be used to set treatment goals, determine baseline stability, and detect change in performance of, and satisfaction with, the goals.
TERMINATED
NA
4 participants
Initial and 5 month follow up
2019-10-04
Participant Flow
Participant milestones
| Measure |
Behavioural
Participant-identified community based activity
Participant-identified community based activity: The Canadian Occupational Performance Measure (COPM) is a client-centered outcome measure designed to detect changes in performance and satisfaction in occupations that the individual has self-identified as being important and difficult to perform. The COPM will be used to set self-identified, community-based activities as treatment goals.
|
|---|---|
|
Overall Study
STARTED
|
4
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Behavioural
Participant-identified community based activity
Participant-identified community based activity: The Canadian Occupational Performance Measure (COPM) is a client-centered outcome measure designed to detect changes in performance and satisfaction in occupations that the individual has self-identified as being important and difficult to perform. The COPM will be used to set self-identified, community-based activities as treatment goals.
|
|---|---|
|
Overall Study
participant withdrew
|
3
|
Baseline Characteristics
participants enrolled but did not complete study
Baseline characteristics by cohort
| Measure |
Behavioural
n=4 Participants
Participant-identified community based activity
Participant-identified community based activity: The Canadian Occupational Performance Measure (COPM) is a client-centered outcome measure designed to detect changes in performance and satisfaction in occupations that the individual has self-identified as being important and difficult to perform. The COPM will be used to set self-identified, community-based activities as treatment goals.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=4 Participants
|
|
Age, Continuous
|
75 years
n=4 Participants • participants enrolled but did not complete study
|
|
Sex: Female, Male
Female
|
3 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=4 Participants
|
|
Region of Enrollment
Canada
|
4 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Initial and 5 month follow upPopulation: data were not collected
The Canadian Occupational Performance Measure (COPM) is a client-centered outcome measure designed to detect changes in performance and satisfaction in occupations that the individual has self-identified as being important and difficult to perform. The COPM has well-established psychometric properties and will be used as the primary outcome measure and will be used to set treatment goals, determine baseline stability, and detect change in performance of, and satisfaction with, the goals.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Initial and 5 month follow-upPopulation: data were not collected
The WHO-DAS 2.0 is a generic self-report health status measure, linked to the concepts of health and disability outlined in the International Classification of Functioning, Disability and Health and is intended to identify limitations in six domains with 36 items, including self-care, and community and social functioning experienced over the past 30 days. The WHO-DAS 2.0 is responsive to change, has excellent internal consistency, established content validity, and high convergent validity. The WHO-DAS 2.0 will be used to identify changes in overall health status that occur through the study. Uses a scale of 1-5 - 1=no difficulty and 5=extreme difficulty or cannot do. Sum of items within each domain are then summed across the 6 domains to result in a general disability summary score, converted to a metric from 0-100 with higher score indicating more disability.
Outcome measures
Outcome data not reported
Adverse Events
Behavioural
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place