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

April 11, 2022 updated by: University of Arkansas
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • University of Arkansas for Medical Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 89 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visits to High-cost Care Settings [ Time Frame: 1.5 Months ]
Time Frame: Through study completion, an average of 1.5 months
Number of visits to ER, urgent care, or hospitalizations because of HS
Through study completion, an average of 1.5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Arkansas

Investigators

  • Principal Investigator: Vivian Y Shi, MD, University of Arkansas

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 20, 2020

Primary Completion (Actual)

December 7, 2020

Study Completion (Actual)

December 7, 2020

Study Registration Dates

First Submitted

October 19, 2020

First Submitted That Met QC Criteria

October 19, 2020

First Posted (Actual)

October 23, 2020

Study Record Updates

Last Update Posted (Actual)

April 13, 2022

Last Update Submitted That Met QC Criteria

April 11, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 261683

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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