- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06123507
A Pragmatic Feasibility Trial to Promote Student Perspective-Taking on Client Physical Activity: A Collaborative Project
November 2, 2023 updated by: University of Manitoba
A Randomized Pragmatic Feasibility Trial to Promote Student Perspective-Taking on Client Physical Activity: A Collaborative Project
This mixed-methods parallel two-arm trial assessed the feasibility, appropriateness, and acceptability of a theoretically-informed intervention designed to improve perspective-taking skills in preparation for a future definitive randomized control trial.
Using a 1:1 allocation ratio, student participants (N = 163) in Respiratory, Physical, and Occupational Therapy; Nurse Practitioner; and Kinesiology programs at a Canadian university were randomly assigned to full or partial intervention conditions.
Full intervention participants completed an online workshop on perspective-taking and practiced perspective-taking prior to an in-lab 10-minute dialogue with a trained client-actor (masked to condition) about the actor's physical inactivity.
Partial intervention participants received the workshop after the dialogue, and were instructed to be aware and mindful of the approach that they took to seek understanding.
To be considered feasible, outcomes needed to meet or surpass our criteria (e.g., within-course recruitment: 85-95% of a course when embedded within a course, 5-10% when not embedded).
Feasibility and appropriateness were assessed by comparing recruitment rates, protocol, and psychometric outcomes to criteria.
Acceptability was assessed by analyzing exit interviews.
Recruitment rates, protocol, and psychometric outcomes largely met criteria, and the study was acceptable.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
163
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
-
-
Manitoba
-
Winnipeg, Manitoba, Canada, R3T 2N2
- University of Manitoba
-
-
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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Must be a student at the University of Manitoba
- Must have completed course content on behaviour change communication
Exclusion Criteria:
- Full intervention participants were excluded from descriptive statistics calculations if they partially completed the workshop or did not complete all phases due to client-actor availability
- Data from participating in additional study sessions were excluded
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: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Full educational intervention condition
The Full intervention condition included a perspective-taking workshop plus independent practice and video-feedback
|
This intervention compares the outcomes where some learn about and practice perspective-taking and others do not.
All participants received at least a partial intervention through getting video-feedback on their dialogue with a client actor.
|
Active Comparator: Partial intervention condition
The Partial intervention condition involved video-feedback alone.
In this condition, participants were provided with a link to the perspective-taking workshop after the study was complete.
|
This intervention compares the outcomes where some learn about and practice perspective-taking and others do not.
All participants received at least a partial intervention through getting video-feedback on their dialogue with a client actor.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Recruitment rate when embedded within a course
Time Frame: Within 2 years of study commencement (February 2018 - December 2019)
|
85-95% recruitment rate
|
Within 2 years of study commencement (February 2018 - December 2019)
|
Recruitment rate when not embedded within a course
Time Frame: Within 2 years of study commencement (February 2018 - December 2019)
|
5-10% recruitment rate
|
Within 2 years of study commencement (February 2018 - December 2019)
|
Recruitment time
Time Frame: Within 2 years of study commencement (February 2018 - December 2019)
|
Time to finish recruiting in years
|
Within 2 years of study commencement (February 2018 - December 2019)
|
Program recruitment
Time Frame: Within 2 years of study commencement (February 2018 - December 2019)
|
Count of number of participants per program
|
Within 2 years of study commencement (February 2018 - December 2019)
|
Workshop completion
Time Frame: Prior to in-lab participation
|
Percent that completed all pages of the workshop
|
Prior to in-lab participation
|
Practice time length
Time Frame: Prior to in-lab participation
|
Time in weeks
|
Prior to in-lab participation
|
Adherence for not making a plan of action with the client-actor
Time Frame: Through in-lab completion, an expected average of 2 hours
|
Percent that adhered to instructions
|
Through in-lab completion, an expected average of 2 hours
|
Lab session length
Time Frame: Through in-lab completion, an expected average of 2 hours
|
Average lab session length, and time participants spent in the lab in hours and minutes
|
Through in-lab completion, an expected average of 2 hours
|
Employee training
Time Frame: Through study completion, up to 2 years
|
Time in hours
|
Through study completion, up to 2 years
|
Appropriateness of measure means as assessed by examining data for floor and ceiling effects
Time Frame: Post study completion, after 2 years
|
A scale mean will be created for all measures.
To assess appropriateness for inclusion in the definitive trial, we will examine the means for floor and ceiling effects.
There should be no evidence of floor or ceiling effects in study measures.
If there is evidence of extreme means, then we will consider a different measure for the definitive trial.
|
Post study completion, after 2 years
|
Amount of missing data
Time Frame: Post study completion, after 2 years
|
To assess appropriateness for inclusion in the definitive trial, the amount of missing data will be examined for each measure.
There should be no more than 5% for each study measure.
If there is evidence of excessive missing data for a measure, then we will consider a different measure for the definitive trial.
|
Post study completion, after 2 years
|
Appropriateness of Cronbach's alpha as assessed by an alpha above .70 for each measure
Time Frame: Post study completion, after 2 years
|
To assess appropriateness for inclusion in the definitive trial, we will calculate Cronbach's alpha for each measure.
Cronbach's alpha should be at least .70 for each study measure.
If there is evidence of low Cronbach's alpha for a measure, then we will consider a different measure for the definitive trial.
|
Post study completion, after 2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Instructor interest
Time Frame: At time of contact through study completion, up to 2 years
|
Count of instructors who express interest in the study
|
At time of contact through study completion, up to 2 years
|
Integration rate
Time Frame: Prior to the study period
|
Count of how many instructors embedded the course into their study
|
Prior to the study period
|
Participant demographics
Time Frame: At baseline
|
Counts and percentages
|
At baseline
|
Prior communication training
Time Frame: At baseline
|
Counts and percentages for self-reported training
|
At baseline
|
Acceptability
Time Frame: Post study completion, after 2 years
|
Examining exit interviews and field notes using manifest content analysis and constant comparison techniques
|
Post study completion, after 2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Shaelyn Strachan, PhD, University of Manitoba
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 (Actual)
February 19, 2018
Primary Completion (Actual)
December 20, 2019
Study Completion (Actual)
December 20, 2019
Study Registration Dates
First Submitted
October 11, 2023
First Submitted That Met QC Criteria
November 2, 2023
First Posted (Estimated)
November 8, 2023
Study Record Updates
Last Update Posted (Estimated)
November 8, 2023
Last Update Submitted That Met QC Criteria
November 2, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- E2018:008
- 48798 (Other Grant/Funding Number: University of Manitoba)
- 322464 (Other Grant/Funding Number: Manitoba Centre for Nursing and Health Research)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
The data will not be shared.
The data are not publicly available because we did not get permission from participants.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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