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

NCT06123507 | Completed

• 3 other identifiers: E2018:00848798322464
• Study Type: interventional
• Target: 163
• Locations: 1 country
• Sites: 1

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.

Conditions

Communication

Keywords

Perspective-taking; Empathy; Education; Feasibility

Outcome Measures

Primary Outcomes (12)

• 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 Outcomes (5)

• Instructor interest

  At time of contact through study completion, up to 2 years

• Integration rate

  Prior to the study period

• Participant demographics

  At baseline

• Prior communication training

  At baseline

• Acceptability

  Post study completion, after 2 years

Study Arms (2)

Full educational intervention condition

EXPERIMENTAL

The Full intervention condition included a perspective-taking workshop plus independent practice and video-feedback

Behavioral: Student practitioner perspective-taking intervention

Partial intervention condition

ACTIVE COMPARATOR

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

Interventions

Student practitioner perspective-taking intervention BEHAVIORAL

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.

Full educational intervention condition; Partial intervention condition

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Must be a student at the University of Manitoba
• Must have completed course content on behaviour change communication

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Manitoba: lead

Study Sites (1)

University of Manitoba

Winnipeg, Manitoba, R3T 2N2, Canada

Location

Related Publications (1)

• Hoplock LB, Lobchuk MM, Strachan SM, Halas G, Olfert C, Webber S, Parsons JL. A randomized pragmatic feasibility trial to promote student perspective-taking on client physical activity level: a collaborative project. Pilot Feasibility Stud. 2024 Sep 28;10(1):123. doi: 10.1186/s40814-024-01547-8.

  PMID: 39342378 DERIVED

MeSH Terms

Conditions

Communication

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Shaelyn Strachan, PhD

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 11, 2023
• First Posted: November 8, 2023
• Study Start: February 19, 2018
• Primary Completion: December 20, 2019
• Study Completion: December 20, 2019
• Last Updated: November 8, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)