Carpal Tunnel SyndromeNCT03868449
Question Prompt List for Common Hand Conditions
A study testing Question Prompt List and 3 questions in people with Carpal Tunnel Syndrome and Trigger Finger, run by Stanford University at 1 site in United States.
Trial summary
Patients with common hand conditions will be randomized to one of two groups- one will receive a question prompt list, the other will receive a list of 3 questions Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carpal Tunnel Syndrome, Trigger Finger, Trigger Thumb
- What is being tested?
- Question Prompt List and 3 questions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Apr 2019to 31 Jul 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with common hand conditions
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford Health Care
Redwood City, California, 94063
About this study
Official title: Does Giving a Question Prompt List to Patients With Common Hand Conditions Improve Their Perceived Involvement in Care? A Randomized Controlled Trial
Patients with common hand conditions will be randomized to one of two groups- one will receive a question prompt list, the other will receive a list of 3 questions
- Conditions
- Carpal Tunnel Syndrome, Trigger Finger, Trigger Thumb, Dupuytren Contracture, Ganglion Cysts
- Being tested
- Question Prompt List, 3 questions
- Medical subject headings
- Carpal Tunnel Syndrome, Trigger Finger Disorder, Dupuytren Contracture, Ganglion Cysts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Question Prompt ListOther
Question prompt list
3 questionsOther
3 questions from the AskShareKnow model
| Study group | Role | What they receive |
|---|---|---|
| Question Prompt List | Experimental | Participants will be given a Question Prompt list that has been developed by the research team Receives: Other: Question Prompt List |
| 3 questions list | Active comparator | Participants will be given 3 questions from the AskShareKnow method Receives: Other: 3 questions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived Involvement in Care scale
This scale measures perceived involvement in care, with higher scores indicating higher perceived involvement
Measured: Immediately after visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2019
- Study start8 Apr 2019
- Primary completion31 Jul 2019
- Study completion31 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carpal Tunnel SyndromeStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- Masking
- None (open label)
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robin Kamal, Stanford University
- Investigators
- Robin N Kamal, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03868449
- Sponsor's protocol ID
- 49833
- Status last verified
- Oct 2019
- First submitted
- 7 Mar 2019
- Last updated
- 16 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share data at this time
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Giving a Question Prompt List to Patients With Common Hand Conditions Improve Their Perceived Involvement in Care? A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03868449
- Acronym / sponsor ID
- 49833
- Conditions
- Carpal Tunnel Syndrome, Trigger Finger, Trigger Thumb, Dupuytren Contracture, Ganglion Cysts
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 8 Apr 2019 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 11 Mar 2019 (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.
Patients with common hand conditions will be randomized to one of two groups- one will receive a question prompt list, the other will receive a list of 3 questions
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Question Prompt List | Experimental | Other: Question Prompt ListParticipants will be given a Question Prompt list that has been developed by the research team |
| 3 questions list | Active comparator | Other: 3 questionsParticipants will be given 3 questions from the AskShareKnow method |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with common hand conditions
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Question Prompt ListQuestion prompt list | Other | Question Prompt List |
| 3 questions3 questions from the AskShareKnow model | Other | 3 questions list |
Primary outcome
Perceived Involvement in Care scale
Time frame: Immediately after visit
This scale measures perceived involvement in care, with higher scores indicating higher perceived involvement
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 16 Oct 2019.
- Individual participant dataSharing planned: No. No plan to share data at this time
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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.
Robin N Kamal, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Question Prompt List and 3 questions in people with Carpal Tunnel Syndrome and Trigger Finger, run by Stanford University 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 1 inclusion and 1 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 16 Oct 2019. 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?
Perceived Involvement in Care scale (time frame: Immediately after visit). 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 16 Oct 2019.