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Evaluating the Effect of a Written Action Plan on Comfort and Understanding of Hidradenitis Suppurativa

Primary Purpose

Hidradenitis Suppurativa

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Verbal consultation
Written Action Plan
Sponsored by
University of Arkansas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hidradenitis Suppurativa

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Those who do not fit the inclusion criteria

Sites / Locations

  • University of Arkansas for Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Verbal Consultation, then Written Action Plan

Experimental: Written Action Plan

Arm Description

CONTROL GROUP Survey A Routine clinic visit Verbal consultation only Survey B Verbal consultation AND Written Action Plan Survey C

INTERVENTION GROUP Survey A Routine clinic visit Verbal consultation AND Written Action Plan Survey C

Outcomes

Primary Outcome Measures

Visits to High-cost Care Settings [ Time Frame: 1.5 Months ]
Number of visits to ER, urgent care, or hospitalizations because of HS

Secondary Outcome Measures

Full Information

First Posted
October 19, 2020
Last Updated
April 11, 2022
Sponsor
University of Arkansas
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1. Study Identification

Unique Protocol Identification Number
NCT04600375
Brief Title
Evaluating the Effect of a Written Action Plan on Comfort and Understanding of Hidradenitis Suppurativa
Official Title
Evaluating the Effect of a Written Action Plan on Comfort and Understanding of Hidradenitis Suppurativa
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
October 20, 2020 (Actual)
Primary Completion Date
December 7, 2020 (Actual)
Study Completion Date
December 7, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arkansas

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hidradenitis Suppurativa

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Verbal Consultation, then Written Action Plan
Arm Type
Other
Arm Description
CONTROL GROUP Survey A Routine clinic visit Verbal consultation only Survey B Verbal consultation AND Written Action Plan Survey C
Arm Title
Experimental: Written Action Plan
Arm Type
Experimental
Arm Description
INTERVENTION GROUP Survey A Routine clinic visit Verbal consultation AND Written Action Plan Survey C
Intervention Type
Behavioral
Intervention Name(s)
Verbal consultation
Intervention Description
Verbal consultation only without written information before receiving written action plan
Intervention Type
Behavioral
Intervention Name(s)
Written Action Plan
Intervention Description
Written handout of treatment plan and disease management strategies
Primary Outcome Measure Information:
Title
Visits to High-cost Care Settings [ Time Frame: 1.5 Months ]
Description
Number of visits to ER, urgent care, or hospitalizations because of HS
Time Frame
Through study completion, an average of 1.5 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Those who do not fit the inclusion criteria
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vivian Y Shi, MD
Organizational Affiliation
University of Arkansas
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
34579620
Citation
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.
Results Reference
derived

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Evaluating the Effect of a Written Action Plan on Comfort and Understanding of Hidradenitis Suppurativa

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