Back to resultsHidradenitis Suppurativa Written Action Plan (HSWAP)
Primary Purpose
Hidradenitis Suppurativa
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Verbal consultation
Written Action Plan
Sponsored by
About this trial
This is an interventional supportive care trial for Hidradenitis Suppurativa
Eligibility Criteria
Inclusion Criteria:
- Has a diagnosis of HS
Exclusion Criteria:
- Has been exposed to a written action plan for HS before
Sites / Locations
- University of Arizona
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
Verbal Consultation, then Written Action Plan
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
Number of visits to ER, urgent care, or hospitalizations because of HS
Secondary Outcome Measures
Full Information
NCT ID
NCT04230291
First Posted
January 13, 2020
Last Updated
September 29, 2020
Sponsor
University of Arizona
Collaborators
University of Arkansas
1. Study Identification
Unique Protocol Identification Number
NCT04230291
Brief Title
Hidradenitis Suppurativa Written Action Plan
Acronym
HSWAP
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
September 2020
Overall Recruitment Status
Terminated
Why Stopped
Principal investigator is not longer at this institution
Study Start Date
February 1, 2020 (Actual)
Primary Completion Date
March 17, 2020 (Actual)
Study Completion Date
March 17, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Arizona
Collaborators
University of Arkansas
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
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
8 (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
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
Description
Number of visits to ER, urgent care, or hospitalizations because of HS
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Has a diagnosis of HS
Exclusion Criteria:
Has been exposed to a written action plan for HS before
Facility Information:
Facility Name
University of Arizona
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85718
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Hidradenitis Suppurativa Written Action Plan
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