A Randomized Pragmatic Feasibility Trial to Promote Student Perspective-Taking on Client Physical Activity: A Collaborative Project
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 163
- 试验地点
- 2
- 主要终点
- Practice time length
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Must be a student at the University of Manitoba
- •Must have completed course content on behaviour change communication
排除标准
- •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
结局指标
主要结局
Practice time length
时间窗: Prior to in-lab participation
Time in weeks
Adherence for not making a plan of action with the client-actor
时间窗: Through in-lab completion, an expected average of 2 hours
Percent that adhered to instructions
Amount of missing data
时间窗: 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
时间窗: 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.
Program recruitment
时间窗: Within 2 years of study commencement (February 2018 - December 2019)
Count of number of participants per program
Appropriateness of measure means as assessed by examining data for floor and ceiling effects
时间窗: 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.
Recruitment time
时间窗: Within 2 years of study commencement (February 2018 - December 2019)
Time to finish recruiting in years
Workshop completion
时间窗: Prior to in-lab participation
Percent that completed all pages of the workshop
Recruitment rate when embedded within a course
时间窗: Within 2 years of study commencement (February 2018 - December 2019)
85-95% recruitment rate
Recruitment rate when not embedded within a course
时间窗: Within 2 years of study commencement (February 2018 - December 2019)
5-10% recruitment rate
Lab session length
时间窗: 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
时间窗: Through study completion, up to 2 years
Time in hours
次要结局
- 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)