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

NCT ID: NCT04600375

Last Updated: 2022-04-13

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-20

Study Completion Date

2020-12-07

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hidradenitis Suppurativa

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type OTHER

Verbal consultation

Intervention Type BEHAVIORAL

Verbal consultation only without written information before receiving written action plan

Written Action Plan

Intervention Type BEHAVIORAL

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

Group Type EXPERIMENTAL

Written Action Plan

Intervention Type BEHAVIORAL

Written handout of treatment plan and disease management strategies

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Verbal consultation

Verbal consultation only without written information before receiving written action plan

Intervention Type BEHAVIORAL

Written Action Plan

Written handout of treatment plan and disease management strategies

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Arkansas

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Vivian Y Shi, MD

Role: PRINCIPAL_INVESTIGATOR

University of Arkansas

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 34579620 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

261683

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Efficacy of Laser Hair Removal Therapy in HS
NCT05762484 NOT_YET_RECRUITING NA
A Study With CIT-013 in HS Patients
NCT06993233 RECRUITING PHASE2