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

Communication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06123507
• Other study ID #: E2018:008
• Secondary ID: 48798322464
• Status: Completed
• Phase: N/A
• Start date: February 19, 2018
• Est. completion date: December 20, 2019

Study information

• Verified date: October 2023
• Source: University of Manitoba
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 163
• Est. completion date: December 20, 2019
• Est. primary completion date: December 20, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Communication

Intervention

Behavioral:
• Student 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.

Locations

Country	Name	City	State
Canada	University of Manitoba	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
University of Manitoba

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment rate when embedded within a course	85-95% recruitment rate	Within 2 years of study commencement (February 2018 - December 2019)
Primary	Recruitment rate when not embedded within a course	5-10% recruitment rate	Within 2 years of study commencement (February 2018 - December 2019)
Primary	Recruitment time	Time to finish recruiting in years	Within 2 years of study commencement (February 2018 - December 2019)
Primary	Program recruitment	Count of number of participants per program	Within 2 years of study commencement (February 2018 - December 2019)
Primary	Workshop completion	Percent that completed all pages of the workshop	Prior to in-lab participation
Primary	Practice time length	Time in weeks	Prior to in-lab participation
Primary	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
Primary	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
Primary	Employee training	Time in hours	Through study completion, up to 2 years
Primary	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
Primary	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
Primary	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	Instructor interest	Count of instructors who express interest in the study	At time of contact through study completion, up to 2 years
Secondary	Integration rate	Count of how many instructors embedded the course into their study	Prior to the study period
Secondary	Participant demographics	Counts and percentages	At baseline
Secondary	Prior communication training	Counts and percentages for self-reported training	At baseline
Secondary	Acceptability	Examining exit interviews and field notes using manifest content analysis and constant comparison techniques	Post study completion, after 2 years