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Hidradenitis Suppurativa Written Action Plan (HSWAP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04230291
Recruitment Status : Terminated (Principal investigator is not longer at this institution)
First Posted : January 18, 2020
Last Update Posted : October 1, 2020
Sponsor:
Collaborator:
University of Arkansas
Information provided by (Responsible Party):
Vivian Shi, University of Arizona

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.

Condition or disease Intervention/treatment Phase
Hidradenitis Suppurativa Behavioral: Verbal consultation Behavioral: Written Action Plan Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Evaluating the Effect of a Written Action Plan on Comfort and Understanding of Hidradenitis Suppurativa
Actual Study Start Date : February 1, 2020
Actual Primary Completion Date : March 17, 2020
Actual Study Completion Date : March 17, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Verbal Consultation, then Written Action Plan

CONTROL 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
Behavioral: Verbal consultation
Verbal consultation only without written information before receiving written action plan

Behavioral: Written Action Plan
Written handout of treatment plan and disease management strategies

Experimental: Written Action Plan

INTERVENTION GROUP

  1. Survey A
  2. Routine clinic visit
  3. Verbal consultation AND Written Action Plan
  4. Survey C
Behavioral: Written Action Plan
Written handout of treatment plan and disease management strategies




Primary Outcome Measures :
  1. Visits to high-cost care settings [ Time Frame: 12 months ]
    Number of visits to ER, urgent care, or hospitalizations because of HS



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Has a diagnosis of HS

Exclusion Criteria:

  • Has been exposed to a written action plan for HS before

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04230291


Locations
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United States, Arizona
University of Arizona
Tucson, Arizona, United States, 85718
Sponsors and Collaborators
University of Arizona
University of Arkansas
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Responsible Party: Vivian Shi, MD, University of Arizona
ClinicalTrials.gov Identifier: NCT04230291    
Other Study ID Numbers: 1910019510
First Posted: January 18, 2020    Key Record Dates
Last Update Posted: October 1, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hidradenitis Suppurativa
Hidradenitis
Sweat Gland Diseases
Skin Diseases
Skin Diseases, Bacterial
Bacterial Infections
Skin Diseases, Infectious
Infection
Suppuration