NCT04230291

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 13, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 18, 2020

Completed
14 days until next milestone

Study Start

First participant enrolled

February 1, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 17, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 17, 2020

Completed
Last Updated

October 1, 2020

Status Verified

September 1, 2020

Enrollment Period

2 months

First QC Date

January 13, 2020

Last Update Submit

September 29, 2020

Conditions

Hidradenitis Suppurativa

Outcome Measures

Primary Outcomes (1)

  • Visits to high-cost care settings

    Number of visits to ER, urgent care, or hospitalizations because of HS

    12 months

Study Arms (2)

Verbal Consultation, then Written Action Plan

OTHER

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 consultationBehavioral: Written Action Plan

Written Action Plan

EXPERIMENTAL

INTERVENTION GROUP 1. Survey A 2. Routine clinic visit 3. Verbal consultation AND Written Action Plan 4. Survey C

Behavioral: Written Action Plan

Interventions

Verbal consultationBEHAVIORAL

Verbal consultation only without written information before receiving written action plan

Verbal Consultation, then Written Action Plan
Written Action PlanBEHAVIORAL

Written handout of treatment plan and disease management strategies

Verbal Consultation, then Written Action PlanWritten Action Plan

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Has a diagnosis of HS

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Arizona

Tucson, Arizona, 85718, United States

Location

MeSH Terms

Conditions

Hidradenitis Suppurativa

Condition Hierarchy (Ancestors)

Skin Diseases, BacterialBacterial InfectionsBacterial Infections and MycosesInfectionsSkin Diseases, InfectiousSuppurationSkin DiseasesSkin and Connective Tissue DiseasesHidradenitisSweat Gland Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 13, 2020

First Posted

January 18, 2020

Study Start

February 1, 2020

Primary Completion

March 17, 2020

Study Completion

March 17, 2020

Last Updated

October 1, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)