Clinical trial NCT06123507: A Pragmatic Feasibility Trial to Promote Student Perspective-Taking on Client Physical Activity: A Collaborative Project
Official title: A Randomized Pragmatic Feasibility Trial to Promote Student Perspective-Taking on Client Physical Activity: A Collaborative Project
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Communication
Keywords: Perspective-taking
Empathy
Education
Feasibility
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2023-11-08
Enrollment: 163
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This randomized mixed-methods parallel two-arm feasibility trial used a 1:1 allocation ratio in Excel. This study's primary purpose was to assess the feasibility, appropriateness, and acceptability of a randomized pilot trial where some health-care students received a Full educational Intervention on perspective-taking and others received a Partial Intervention.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Recruitment rate when embedded within a course
timeFrame: Within 2 years of study commencement (February 2018 - December 2019)
measure: Recruitment rate when not embedded within a course
timeFrame: Within 2 years of study commencement (February 2018 - December 2019)
measure: Recruitment time
timeFrame: Within 2 years of study commencement (February 2018 - December 2019)
measure: Program recruitment
timeFrame: Within 2 years of study commencement (February 2018 - December 2019)
measure: Workshop completion
timeFrame: Prior to in-lab participation
measure: Practice time length
timeFrame: Prior to in-lab participation
measure: Adherence for not making a plan of action with the client-actor
timeFrame: Through in-lab completion, an expected average of 2 hours
measure: Lab session length
timeFrame: Through in-lab completion, an expected average of 2 hours
measure: Employee training
timeFrame: Through study completion, up to 2 years
measure: Appropriateness of measure means as assessed by examining data for floor and ceiling effects
timeFrame: Post study completion, after 2 years
measure: Amount of missing data
timeFrame: Post study completion, after 2 years
measure: Appropriateness of Cronbach's alpha as assessed by an alpha above .70 for each measure
timeFrame: Post study completion, after 2 years
Secondary outcomes:
measure: Instructor interest
timeFrame: At time of contact through study completion, up to 2 years
measure: Integration rate
timeFrame: Prior to the study period
measure: Participant demographics
timeFrame: At baseline
measure: Prior communication training
timeFrame: At baseline
measure: Acceptability
timeFrame: Post study completion, after 2 years
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: University of Manitoba
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Shaelyn Strachan, PhD
role: PRINCIPAL_INVESTIGATOR
References: