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A Pragmatic Feasibility Trial to Promote Student Perspective-Taking on Client Physical Activity: A Collaborative Project

A Randomized Pragmatic Feasibility Trial to Promote Student Perspective-Taking on Client Physical Activity: A Collaborative Project

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06123507
Enrollment
163
Registered
2023-11-08
Start date
2018-02-19
Completion date
2019-12-20
Last updated
2023-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Communication

Keywords

Perspective-taking, Empathy, Education, Feasibility

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.

Interventions

BEHAVIORALStudent practitioner perspective-taking intervention

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.

Sponsors

University of Manitoba
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Masking description

Client-actors were masked to condition. Investigators were masked while determining participants' perceptual understanding scores (i.e., how accurate participants were at inferring the client-actor's thoughts and feelings). In-lab research assistants were not masked to condition.

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.

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Appropriateness of Cronbach's alpha as assessed by an alpha above .70 for each measurePost study completion, after 2 yearsTo 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.
Adherence for not making a plan of action with the client-actorThrough in-lab completion, an expected average of 2 hoursPercent that adhered to instructions
Lab session lengthThrough in-lab completion, an expected average of 2 hoursAverage lab session length, and time participants spent in the lab in hours and minutes
Employee trainingThrough study completion, up to 2 yearsTime in hours
Appropriateness of measure means as assessed by examining data for floor and ceiling effectsPost study completion, after 2 yearsA 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.
Amount of missing dataPost study completion, after 2 yearsTo 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.
Recruitment rate when embedded within a courseWithin 2 years of study commencement (February 2018 - December 2019)85-95% recruitment rate
Recruitment rate when not embedded within a courseWithin 2 years of study commencement (February 2018 - December 2019)5-10% recruitment rate
Recruitment timeWithin 2 years of study commencement (February 2018 - December 2019)Time to finish recruiting in years
Program recruitmentWithin 2 years of study commencement (February 2018 - December 2019)Count of number of participants per program
Workshop completionPrior to in-lab participationPercent that completed all pages of the workshop
Practice time lengthPrior to in-lab participationTime in weeks

Secondary

MeasureTime frameDescription
Integration ratePrior to the study periodCount of how many instructors embedded the course into their study
Participant demographicsAt baselineCounts and percentages
Prior communication trainingAt baselineCounts and percentages for self-reported training
AcceptabilityPost study completion, after 2 yearsExamining exit interviews and field notes using manifest content analysis and constant comparison techniques
Instructor interestAt time of contact through study completion, up to 2 yearsCount of instructors who express interest in the study

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026