Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04603430 |
| Other study ID # |
827 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
June 22, 2020 |
| Est. completion date |
November 30, 2021 |
Study information
| Verified date |
November 2022 |
| Source |
Utica College |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The STEPS program is a wellness program where senior citizens are partnered with Doctor of
Physical Therapy (DPT) students, who design individualized fitness plans for each senior
participant. In both the Spring and Fall semesters, first- and second year DPT student teams
provide guided interventions based upon the fitness goals and initial examination findings of
each participant. Program sessions are held once a week for one hour at a local senior
wellness center located in Utica, NY. Facility membership requirements include a small annual
membership fee and stipulate that members must be 55 years of age or older. The STEPS
participants are recruited primarily by word of mouth.
The aim of the STEPS program is to provide an accessible fitness service to improve the
health of the Utica community while also supplementing the clinical experiences of students
enrolled in the DPT program at Utica College. The program gives students an opportunity to
practice clinical skills and reasoning on a weekly basis, and establishes a mentorship
component between students. Second-year students are enrolled in a clinical education course
for both the Fall (DPT 689) and Spring semesters (DPT 699). Examination and interventions are
documented on the WebPT electronic medical record system. Participant reassessments are
conducted twice, halfway through the semester and again at the end of the program.
PURPOSE OF STUDY Clinics and health programs facilitated by students allow clinical
experiences to be interwoven throughout the curriculum and provide students with the
opportunity to learn and serve in their community. Research regarding these programs has
primarily centered around pro-bono clinics run by medical students, and has been limited to
the impact these programs have upon learning. No research has been conducted regarding how a
local senior wellness program, such as the STEPS program, impacts senior fitness and DPT
student engagement. This study will assess the effect that the STEPS program has upon the
health of local seniors, while also qualitatively investigating the impact that the program
has had upon the lives of local seniors and students.
In order to answer these research questions, a retrospective chart review will be conducted
to evaluate the functional outcomes of participating seniors. Additionally, qualitative focus
groups will be convened to reflect upon the impact that the STEPS program has had upon the
seniors and students.
Description:
STUDY DESIGN A mixed-method study design will be used to assess functional outcomes of the
Students Teaching Elderly Prevention and Safety (STEPS) program on senior participants, as
well as the impact of the program on both participants and students. In order to assess
functional outcomes, a retrospective chart review will be conducted on a convenience sample
of participants enrolled in the STEPS program from September 2018 to April 2019.
In order to explore participant and student perspectives of the STEPS program, a Glaserian
grounded theory approach will be utilized. Grounded theory is a qualitative research
methodology commonly employed in healthcare research due to its inductive, systematic process
of gathering and interpreting data. Data gleaned from focus groups is continuously analyzed
for patterns, from which a thematic consensus emerges. Semi -structured interview questions
will be proposed to focus groups of students and senior participants who were involved in the
STEPS program during the study time frame. Prior to starting the focus group discussion,
subjects will be given a demographic survey to complete.
DEMOGRAPHIC SURVEYS Demographic information will be collected from senior participants and
students via a written survey filled out prior to the focus group session.
INTERVIEW QUESTIONS Questions will be pilot tested with a purposive sample of eligible STEPS
participants and students. Questions will be used to direct the focus groups, however, focus
group discussion will be not restricted to these topics, as the Glaserian grounded theory
approach allows for focus group members to guide the discussion process. Depending on
feedback gained from pilot focus group sessions, questions may be modified.
PILOT INTERVIEWS In order to assess the construct validity of proposed focus group questions,
prospective questions will be pilot tested with a group of seniors and students who
participated in the STEPS program prior to the 2018-2019 academic year. Focus groups of pilot
testers will be conducted in a manner similar to their respective demographic cohort. Focus
groups of student pilot testers will be convened over a private virtual chat platform. Focus
groups of senior pilot testers will be convened in a private virtual chat room. Each pilot
sessions will last for fort-five to sixty-minutes, and will end when saturation is achieved.
One or two researchers will facilitate the focus groups and another researcher will observe
the session.
STEPS PARTICIPANT INTERVIEWS In order to assess the impact that the STEPS program has upon
seniors, focus groups of 4 to 6 subjects will be convened for forty-five to sixty-minute-long
sessions in a private virtual chat room. Sessions will end when saturation is met, meaning
that no new insights are being revealed by focus group members. One or two researchers will
facilitate the focus groups and another researcher will observe the focus group and take
field notes. All researchers will receive training regarding proctoring focus groups. Focus
groups will be conducted between June 2020 and November 2020 and will be audio-taped and
later transcribed by the researchers. After transcription is complete, transcripts will be
reviewed by research participants to confirm that transcription and initial interpretation
objectively captured participant insights.
STUDENT INTERVIEWS In order to assess the impact that the STEPS program has upon students,
focus groups of 4 to 6 subjects will be convened for forty-five to sixty-minute-long sessions
in a private virtual chat platform. Sessions will end when saturation is met, meaning that no
new insights are being revealed by focus group members. One or two researchers will
facilitate the focus groups and another researcher will observe the focus group and take
field notes. The focus group facilitators have had no prior relationship with student
participants. No-one else, aside from focus group members and researchers, will be present
during the sessions. Focus groups will be conducted between June 2020 and November 2020 and
will be audio-taped and later transcribed by the researchers. After transcription is
complete, transcripts will be reviewed by research participants to confirm that transcription
and initial interpretation objectively captured participant insights.
