CommunicationNCT06123507
A Pragmatic Feasibility Trial to Promote Student Perspective-Taking on Client Physical Activity: A Collaborative Project
A study testing Student practitioner perspective-taking intervention in people with Communication, run by University of Manitoba at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Communication
- What is being tested?
- Student practitioner perspective-taking intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 163 participants
- Where
- 1 siteCanada
- Study dates
- 19 Feb 2018to 20 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Must be a student at the University of Manitoba
- Must have completed course content on behaviour change communication
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized 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.
- Conditions
- Communication
- Being tested
- Student practitioner perspective-taking intervention
- Keywords
- Perspective-taking, Empathy, Education, Feasibility
- Medical subject headings
- Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Student practitioner perspective-taking interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Full educational intervention condition | Experimental | The Full intervention condition included a perspective-taking workshop plus independent practice and video-feedback Receives: 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. Receives: Behavioral: Student practitioner perspective-taking intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate when embedded within a course
85-95% recruitment rate
Measured: Within 2 years of study commencement (February 2018 - December 2019)
Recruitment rate when not embedded within a course
5-10% recruitment rate
Measured: Within 2 years of study commencement (February 2018 - December 2019)
Recruitment time
Time to finish recruiting in years
Measured: Within 2 years of study commencement (February 2018 - December 2019)
Program recruitment
Count of number of participants per program
Measured: Within 2 years of study commencement (February 2018 - December 2019)
Workshop completion
Percent that completed all pages of the workshop
Measured: Prior to in-lab participation
Practice time length
Time in weeks
Measured: Prior to in-lab participation
Adherence for not making a plan of action with the client-actor
Percent that adhered to instructions
Measured: 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
Measured: Through in-lab completion, an expected average of 2 hours
Employee training
Time in hours
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Post study completion, after 2 years
Secondary outcomes (5)
Instructor interest
Count of instructors who express interest in the study
Measured: At time of contact through study completion, up to 2 years
Integration rate
Count of how many instructors embedded the course into their study
Measured: Prior to the study period
Participant demographics
Counts and percentages
Measured: At baseline
Prior communication training
Counts and percentages for self-reported training
Measured: At baseline
Acceptability
Examining exit interviews and field notes using manifest content analysis and constant comparison techniques
Measured: Post study completion, after 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2023
- Study start19 Feb 2018
- Primary completion20 Dec 2019
- Study completion20 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CommunicationStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Outcomes assessor
- Enrolment
- 163 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shaelyn Strachan, PhD, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06123507
- Sponsor's protocol ID
- E2018:008
- Other IDs
- 48798, 322464
- Status last verified
- Oct 2023
- First submitted
- 11 Oct 2023
- Last updated
- 8 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data will not be shared. The data are not publicly available because we did not get permission from participants.
Publications
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.
PubMed 39342378
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Pragmatic Feasibility Trial to Promote Student Perspective-Taking on Client Physical Activity: A Collaborative Project
- ClinicalTrials.gov ID
- NCT06123507
- Acronym / sponsor ID
- E2018:008
- Conditions
- Communication
- Keywords
- Perspective-taking, Empathy, Education, Feasibility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 163 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- 19 Feb 2018 (actual)
- Primary completion
- 20 Dec 2019 (actual)
- Study completion
- 20 Dec 2019 (actual)
- First posted
- 8 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Full educational intervention condition | Experimental | Behavioral: Student practitioner perspective-taking interventionThe Full intervention condition included a perspective-taking workshop plus independent practice and video-feedback |
| Partial intervention condition | Active comparator | Behavioral: Student practitioner perspective-taking interventionThe 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Must be a student at the University of Manitoba
- Must have completed course content on behaviour change communication
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Student practitioner perspective-taking interventionThis 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. | Behavioural | Full educational intervention condition, Partial intervention condition |
Primary outcome
Recruitment rate when embedded within a course
Time frame: Within 2 years of study commencement (February 2018 - December 2019)
85-95% recruitment rate
Recruitment rate when not embedded within a course
Time frame: Within 2 years of study commencement (February 2018 - December 2019)
5-10% recruitment rate
Recruitment time
Time frame: Within 2 years of study commencement (February 2018 - December 2019)
Time to finish recruiting in years
Program recruitment
Time frame: Within 2 years of study commencement (February 2018 - December 2019)
Count of number of participants per program
Workshop completion
Time frame: Prior to in-lab participation
Percent that completed all pages of the workshop
Practice time length
Time frame: Prior to in-lab participation
Time in weeks
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
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
Employee training
Time frame: Through study completion, up to 2 years
Time in hours
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.
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.
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.
5 secondary outcomes
Instructor interest
Time frame: At time of contact through study completion, up to 2 years
Integration rate
Time frame: Prior to the study period
Participant demographics
Time frame: At baseline
Prior communication training
Time frame: At baseline
Acceptability
Time frame: Post study completion, after 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2023.
- Derived from this study: PubMed 39342378Hoplock 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.
- Individual participant dataSharing planned: No. The data will not be shared. The data are not publicly available because we did not get permission from participants.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shaelyn Strachan, PhD principal investigator
University of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Student practitioner perspective-taking intervention in people with Communication, run by University of Manitoba at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate when embedded within a course (time frame: Within 2 years of study commencement (February 2018 - December 2019)). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06123507, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2023.