Self-preformed Hand ExaminationNCT05790811
Engaging Patients for Physical Exams During Virtual Care Visits
A study testing Physician-oriented Video and Patient-oriented video in people with Self-preformed Hand Examination, run by Henry Ford Health System at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Self-preformed Hand Examination
- What is being tested?
- Physician-oriented Video and Patient-oriented video
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2023to 31 Dec 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Self-preformed Hand Examination
- Being tested
- Physician-oriented Video, Patient-oriented video
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physician-oriented VideoOther
previously validated Hand and Wrist Examination Video by NEJM designed for usage by a physician in diagnosing common hand and wrist diagnoses
Patient-oriented videoOther
The previously validated Hand and Wrist Examination Video by NEJM was modified via the "TogoTiki" application and approved by a patient advisory council.
| Study group | Role | What they receive |
|---|---|---|
| patient-oriented video | Experimental | 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. Receives: Other: Patient-oriented video |
| physician-oriented training video | Active comparator | A physician-oriented video with the goal of instructing physicians on the maneuvers needed to make specific diagnoses of the hand and wrist. Receives: Other: Physician-oriented Video |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge Score immediately following the viewing of a video presenting the knowledge
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.
Measured: 10 minutes after viewing the video
Secondary outcomes (1)
Knowledge Score immediately prior to the viewing of a video presenting the knowledge
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.
Measured: 10 minutes before viewing the video
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2023
- Study start1 Jun 2023
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Self-preformed Hand ExaminationStudies of the same condition, open and under way.
- More trials run by Henry Ford Health SystemThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Charles S Day, Henry Ford Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05790811
- Sponsor's protocol ID
- 14760
- Status last verified
- Feb 2024
- First submitted
- 19 Jan 2023
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Hand & Wrist Physical Exam Video Aid for Improvement of Patient Comprehension
- ClinicalTrials.gov ID
- NCT05790811
- Acronym / sponsor ID
- 14760
- Conditions
- Self-preformed Hand Examination
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 30 Mar 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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patient-oriented video | Experimental | Other: Patient-oriented videoA 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. |
| physician-oriented training video | Active comparator | Other: Physician-oriented VideoA physician-oriented video with the goal of instructing physicians on the maneuvers needed to make specific diagnoses of the hand and wrist. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Physician-oriented Videopreviously validated Hand and Wrist Examination Video by NEJM designed for usage by a physician in diagnosing common hand and wrist diagnoses | Other | physician-oriented training video |
| Patient-oriented videoThe previously validated Hand and Wrist Examination Video by NEJM was modified via the "TogoTiki" application and approved by a patient advisory council. | Other | patient-oriented video |
Primary outcome
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.
1 secondary outcome
Knowledge Score immediately prior to the viewing of a video presenting the knowledge
Time frame: 10 minutes before viewing the video
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 20 Feb 2024.
- Individual participant dataSharing planned: Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physician-oriented Video and Patient-oriented video in people with Self-preformed Hand Examination, run by Henry Ford Health System at 1 site in United States.
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 3 inclusion and 4 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 20 Feb 2024. 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 United States. 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?
Knowledge Score immediately following the viewing of a video presenting the knowledge (time frame: 10 minutes after viewing the video). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Feb 2024.