Evaluating the Effect of a Written Action Plan on Comfort and Understanding of Hidradenitis Suppurativa
1 other identifier
interventional
22
1 country
1
Brief Summary
This study is being conducted to evaluate if a written action plan for hidradenitis suppurativa (HS) will help patients with hidradenitis suppurativa gain a better understanding of the condition and how to manage the condition on a daily basis compared to a routine verbal consultation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2020
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 19, 2020
CompletedStudy Start
First participant enrolled
October 20, 2020
CompletedFirst Posted
Study publicly available on registry
October 23, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 7, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 7, 2020
CompletedResults Posted
Study results publicly available
April 6, 2022
CompletedApril 13, 2022
February 1, 2022
2 months
October 19, 2020
November 30, 2021
April 11, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Visits to High-cost Care Settings [ Time Frame: 1.5 Months ]
Number of visits to ER, urgent care, or hospitalizations because of HS
Through study completion, an average of 1.5 months
Study Arms (2)
Verbal Consultation, then Written Action Plan
OTHERCONTROL GROUP 1. Survey A 2. Routine clinic visit 3. Verbal consultation only 4. Survey B 5. Verbal consultation AND Written Action Plan 6. Survey C
Experimental: Written Action Plan
EXPERIMENTALINTERVENTION GROUP 1. Survey A 2. Routine clinic visit 3. Verbal consultation AND Written Action Plan 4. Survey C
Interventions
Verbal consultation only without written information before receiving written action plan
Written handout of treatment plan and disease management strategies
Eligibility Criteria
You may qualify if:
- This study will only enroll subjects between the ages of 18-years and 89-years of age.
- Diagnosis of HS by a board-certified dermatologist
- Able to read and comprehend study materials
- No prior exposure to written HS action plans
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205, United States
Related Publications (1)
Thompson AM, Fernandez JM, Shih T, Hamzavi I, Hsiao JL, Shi VY. Improving hidradenitis suppurativa patient education using written action plan: a randomized controlled trial. J Dermatolog Treat. 2022 Aug;33(5):2677-2679. doi: 10.1080/09546634.2021.1970707. Epub 2021 Sep 27.
PMID: 34579620DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Vivian Shi
- Organization
- University of Arkansas for Medical Sciences
Study Officials
- PRINCIPAL INVESTIGATOR
Vivian Y Shi, MD
University of Arkansas
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 19, 2020
First Posted
October 23, 2020
Study Start
October 20, 2020
Primary Completion
December 7, 2020
Study Completion
December 7, 2020
Last Updated
April 13, 2022
Results First Posted
April 6, 2022
Record last verified: 2022-02