Trigger Finger Preference Elicitation Tool | NCT03909490

Studies
Trigger Finger Preference Elicitation Tool

NCT03909490

Sponsor

Stanford University

Status

Terminated

Last Update Posted

Nov 12, 2021Actual

Enrollment

10Actual

Phase

Not Applicable

Conditions

Trigger Finger
Trigger Thumb
Trigger Digit
Trigger Finger Disorder
Trigger Thumb, Left Thumb
Trigger Thumb, Right Thumb
Trigger Finger, Ring Finger
Trigger Finger, Index Finger
Trigger Finger, Middle Finger
Trigger Finger, Little Finger
Trigger Thumb, Unspecified Thumb
Trigger Finger, Unspecified Finger

Interventions

Preference elicitation tool
handout

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Nov 2021

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Logistics (research personnel)

Expanded Access Info

Start Date

Mar 20, 2019Actual

Primary Completion Date

Jul 1, 2021Actual

Completion Date

Jul 1, 2021Actual

First Submitted Date

Apr 8, 2019

First Submission Date that Met QC Criteria

Apr 8, 2019

First Posted Date

Apr 10, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 5, 2021

Last Update Posted Date

Nov 12, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to evaluate a patient's level of decisional conflict for their treatment decision regarding their trigger finger, and study if the use of a preference elicitation tool at point of care is able to alter the level of decisional conflict

Detailed Description

All patients presenting to the Hand Surgery clinic for evaluation of a new trigger finger will be approached for inclusion in the study. Upon diagnosis, a patient diagnosed with a trigger will be informed of the study, asked if they would like to participate, and consented into the study. Patients will then be randomized to a control group versus our test group. The control group will be given a generic handout about trigger finger and the treatment options. They will then complete the decisional conflict survey without using the tool. The second group will use the tool and then complete the decisional conflict survey.

The standard of care is not being altered- all treatment options will still be available to patients and they have select whatever option is most in line with their preference for treatment. The purpose of the tool is to facilitate preference elicitation for treatment.

Conditions Module

Conditions

Trigger Finger
Trigger Thumb
Trigger Digit
Trigger Finger Disorder
Trigger Thumb, Left Thumb
Trigger Thumb, Right Thumb
Trigger Finger, Ring Finger
Trigger Finger, Index Finger
Trigger Finger, Middle Finger
Trigger Finger, Little Finger
Trigger Thumb, Unspecified Thumb
Trigger Finger, Unspecified Finger

Keywords

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control	Active Comparator		Other: handout
intervention- tool	Experimental		Other: Preference elicitation tool

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Preference elicitation tool	Other	Ranking tool to assess patient preferences for trigger finger treatment	intervention- tool

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Decisional Conflict Scale (DCS)	Decisional Conflict Scale (DCS) is a validated tool that measures a state of uncertainty about a course of action. DCS is a 16 item scale, scores range from 0-100, with higher scores indicating greater decisional conflict	Immediately after visit

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

diagnosis of trigger finger

Exclusion Criteria:

prior trigger finger treatment

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Robin Kamal	Stanford University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Stanford Health Care		Redwood City	California	94063	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

ID	Term
D053682	Tendon Entrapment
D052256	Tendinopathy
D009135	Muscular Diseases
D009140	Musculoskeletal Diseases