- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05790811
Engaging Patients for Physical Exams During Virtual Care Visits
February 15, 2024 updated by: Charles S Day, Henry Ford Health System
Validation of Hand & Wrist Physical Exam Video Aid for Improvement of Patient Comprehension
The goal of this clinical trial is to validate patient-oriented edits to a guided video on self-performed hand examination in participants with no prior hand diagnoses or medical background. The study aims to:
- examine the effect of adding interactive components to an existing orthopedic provider video
- determine if these changes enhance patients' understanding of hand and wrist anatomy as well as carpal tunnel syndrome
- determine if patients are able to use this video to perform an effective physical exam Participants will watch an original physician-oriented training video and a second version (patient-oriented video), which was edited with the input of a patient advisory committee to include interactive elements and a slower speed. The order in which the participants will watch the video will be randomized.
If there is a comparison group: Researchers will compare knowledge scores and general patient preference between the two videos being examined.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Michigan
-
Detroit, Michigan, United States, 48202
- Henry Ford Health System
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Patients older than 18 years of age
- Patients who comprehend and speak English
- Patients with carpal tunnel syndrome confirmed on EMG and/or symptoms consistent with carpal tunnel syndrome, including bilateral hand pain, non-traumatic hand pain, and/or numbness/tingling in hand.
Exclusion Criteria:
- Patients under 18 years of age
- Patients who do not speak or comprehend English
- Patients who have cognitive impairments that would be detrimental to understanding of video
- Patients whose symptoms do not match carpal tunnel syndrome
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: patient-oriented video
A patient-oriented video with the goal of instructing patients about the maneuvers needed to make specific diagnoses of the hand and wrist.
Wording was changed so that it was more patient friendly and text was added to the screen.
|
The previously validated Hand and Wrist Examination Video by NEJM was modified via the "TogoTiki" application and approved by a patient advisory council.
|
|
Active Comparator: physician-oriented training video
A physician-oriented video with the goal of instructing physicians on the maneuvers needed to make specific diagnoses of the hand and wrist.
|
previously validated Hand and Wrist Examination Video by NEJM designed for usage by a physician in diagnosing common hand and wrist diagnoses
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Knowledge Score immediately following the viewing of a video presenting the knowledge
Time Frame: 10 minutes after viewing the video
|
Score of the quiz examining the understanding of the contents of the video by the participants.
Scoring was a likert scale of 1-5 where 5 represented easy to understand and 1 was very difficult to understand.
Separate questions scored as a 1 or 0 where 1 equated to answering the knowledge question correctly and 0 was answering the question incorrectly.
|
10 minutes after viewing the video
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Knowledge Score immediately prior to the viewing of a video presenting the knowledge
Time Frame: 10 minutes before viewing the video
|
Score of the quiz examining the participants' understanding prior to watching the video.
Scoring was a likert scale of 1-5 where 5 represented easy to understand and 1 was very difficult to understand.
Separate questions scored as a 1 or 0 where 1 equated to answering the knowledge question correctly and 0 was answering the question incorrectly.
|
10 minutes before viewing the video
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2023
Primary Completion (Actual)
December 31, 2023
Study Completion (Actual)
December 31, 2023
Study Registration Dates
First Submitted
January 19, 2023
First Submitted That Met QC Criteria
March 16, 2023
First Posted (Actual)
March 30, 2023
Study Record Updates
Last Update Posted (Actual)
February 20, 2024
Last Update Submitted That Met QC Criteria
February 15, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- 14760
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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