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

Study Overview
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Brief Summary
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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.

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

Conditions
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Communication

Intervention / Treatment
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* Behavioral: Student practitioner perspective-taking intervention


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Full educational intervention condition<br>The Full intervention condition included a perspective-taking workshop plus independent practice and video-feedback | Behavioral: Student practitioner perspective-taking intervention<br>* 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.<br>|
| Active Comparator: Partial intervention condition<br>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. | Behavioral: Student practitioner perspective-taking intervention<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recruitment rate when embedded within a course | 85-95% recruitment rate | Within 2 years of study commencement (February 2018 - December 2019) | 
| Recruitment rate when not embedded within a course | 5-10% recruitment rate | Within 2 years of study commencement (February 2018 - December 2019) | 
| Recruitment time | Time to finish recruiting in years | Within 2 years of study commencement (February 2018 - December 2019) | 
| Program recruitment | Count of number of participants per program | Within 2 years of study commencement (February 2018 - December 2019) | 
| Workshop completion | Percent that completed all pages of the workshop | Prior to in-lab participation | 
| Practice time length | Time in weeks | Prior to in-lab participation | 
| Adherence for not making a plan of action with the client-actor | Percent that adhered to instructions | Through in-lab completion, an expected average of 2 hours | 
| Lab session length | 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 in hours | Through study completion, up to 2 years | 
| Appropriateness of measure means as assessed by examining data for floor and ceiling effects | 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 | 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 | 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 | Count of instructors who express interest in the study | At time of contact through study completion, up to 2 years | 
| Integration rate | Count of how many instructors embedded the course into their study | Prior to the study period | 
| Participant demographics | Counts and percentages | At baseline | 
| Prior communication training | Counts and percentages for self-reported training | At baseline | 
| Acceptability | Examining exit interviews and field notes using manifest content analysis and constant comparison techniques | Post study completion, after 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Perspective-taking, Empathy, Education, Feasibility