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.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

4 participants

Primary outcome timeframe

Initial and 5 month follow up

Results posted on

2019-10-04

Participant Flow

Participant milestones

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

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

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 up

Population: 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-up

Population: 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 events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jacquie Ripat

University of Manitoba

Phone: 204-789-3303

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place