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

Sponsor
University of Manitoba (Other)
Overall Status
Completed
CT.gov ID
NCT06123507
Collaborator
(none)
163
1
2
22
7.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Student practitioner perspective-taking intervention
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
163 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
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.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 (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.
Primary Purpose:
Health Services Research
Official Title:
A Randomized Pragmatic Feasibility Trial to Promote Student Perspective-Taking on Client Physical Activity: A Collaborative Project
Actual Study Start Date :
Feb 19, 2018
Actual Primary Completion Date :
Dec 20, 2019
Actual Study Completion Date :
Dec 20, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Full educational intervention condition

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

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.

Active Comparator: Partial intervention condition

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
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.

Outcome Measures

Primary Outcome Measures

  1. Recruitment rate when embedded within a course [Within 2 years of study commencement (February 2018 - December 2019)]

    85-95% recruitment rate

  2. Recruitment rate when not embedded within a course [Within 2 years of study commencement (February 2018 - December 2019)]

    5-10% recruitment rate

  3. Recruitment time [Within 2 years of study commencement (February 2018 - December 2019)]

    Time to finish recruiting in years

  4. Program recruitment [Within 2 years of study commencement (February 2018 - December 2019)]

    Count of number of participants per program

  5. Workshop completion [Prior to in-lab participation]

    Percent that completed all pages of the workshop

  6. Practice time length [Prior to in-lab participation]

    Time in weeks

  7. Adherence for not making a plan of action with the client-actor [Through in-lab completion, an expected average of 2 hours]

    Percent that adhered to instructions

  8. Lab session length [Through in-lab completion, an expected average of 2 hours]

    Average lab session length, and time participants spent in the lab in hours and minutes

  9. Employee training [Through study completion, up to 2 years]

    Time in hours

  10. Appropriateness of measure means as assessed by examining data for floor and ceiling effects [Post study completion, after 2 years]

    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.

  11. Amount of missing data [Post study completion, after 2 years]

    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.

  12. Appropriateness of Cronbach's alpha as assessed by an alpha above .70 for each measure [Post study completion, after 2 years]

    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.

Secondary Outcome Measures

  1. Instructor interest [At time of contact through study completion, up to 2 years]

    Count of instructors who express interest in the study

  2. Integration rate [Prior to the study period]

    Count of how many instructors embedded the course into their study

  3. Participant demographics [At baseline]

    Counts and percentages

  4. Prior communication training [At baseline]

    Counts and percentages for self-reported training

  5. Acceptability [Post study completion, after 2 years]

    Examining exit interviews and field notes using manifest content analysis and constant comparison techniques

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Manitoba Winnipeg Manitoba Canada R3T 2N2

Sponsors and Collaborators

  • University of Manitoba

Investigators

  • Principal Investigator: Shaelyn Strachan, PhD, University of Manitoba

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Manitoba
ClinicalTrials.gov Identifier:
NCT06123507
Other Study ID Numbers:
  • E2018:008
  • 48798
  • 322464
First Posted:
Nov 8, 2023
Last Update Posted:
Nov 8, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of Manitoba

Study Results

No Results Posted as of Nov 8, 2023