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Completed

NCT Number: NCT06123507

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

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.

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Key information

Conditions

Communication Behavior

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Manitoba

Winnipeg, Manitoba, R3T 2N2, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Recruitment rate when embedded within a course

    Time frame: Within 2 years of study commencement (February 2018 - December 2019)

    85-95% recruitment rate

  2. Recruitment rate when not embedded within a course

    Time frame: Within 2 years of study commencement (February 2018 - December 2019)

    5-10% recruitment rate

  3. Recruitment time

    Time frame: Within 2 years of study commencement (February 2018 - December 2019)

    Time to finish recruiting in years

  4. Program recruitment

    Time frame: Within 2 years of study commencement (February 2018 - December 2019)

    Count of number of participants per program

  5. Workshop completion

    Time frame: Prior to in-lab participation

    Percent that completed all pages of the workshop

  6. Practice time length

    Time frame: Prior to in-lab participation

    Time in weeks

  7. Adherence for not making a plan of action with the client-actor

    Time frame: Through in-lab completion, an expected average of 2 hours

    Percent that adhered to instructions

  8. Lab session length

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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 outcomes

  1. Instructor interest

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

    Count of instructors who express interest in the study

  2. Integration rate

    Time frame: Prior to the study period

    Count of how many instructors embedded the course into their study

  3. Participant demographics

    Time frame: At baseline

    Counts and percentages

  4. Prior communication training

    Time frame: At baseline

    Counts and percentages for self-reported training

  5. Acceptability

    Time frame: Post study completion, after 2 years

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

Sponsors and collaborators

Lead sponsor

University of Manitoba

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 8, 2023
Registry last updated
Nov 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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