Hidradenitis Suppurativa
Conditions
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.
Interventions
BEHAVIORALVerbal consultation
Verbal consultation only without written information before receiving written action plan
BEHAVIORALWritten Action Plan
Written handout of treatment plan and disease management strategies
Sponsors
University of Arkansas
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visits to High-cost Care Settings [ Time Frame: 1.5 Months ] | Through study completion, an average of 1.5 months | Number of visits to ER, urgent care, or hospitalizations because of HS |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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
Verbal consultation: Verbal consultation only without written information before receiving written action plan
Written Action Plan: Written handout of treatment plan and disease management strategies | 12 |
| Experimental: Written Action Plan INTERVENTION GROUP
1. Survey A
2. Routine clinic visit
3. Verbal consultation AND Written Action Plan
4. Survey C
Written Action Plan: Written handout of treatment plan and disease management strategies | 10 |
| Total | 22 |
Baseline characteristics
| Characteristic | Experimental: Written Action Plan | Total | Verbal Consultation, Then Written Action Plan |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants | 22 Participants | 12 Participants |
| Age, Continuous | 34.2 years STANDARD_DEVIATION 11.9 | 33.3 years STANDARD_DEVIATION 10.1 | 32.6 years STANDARD_DEVIATION 8.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 10 Participants | 22 Participants | 12 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 10 participants | 22 participants | 12 participants |
| Sex: Female, Male Female | 5 Participants | 17 Participants | 12 Participants |
| Sex: Female, Male Male | 5 Participants | 5 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 10 |
| other Total, other adverse events | 0 / 12 | 0 / 10 |
| serious Total, serious adverse events | 0 / 12 | 0 / 10 |
Outcome results
Primary
Visits to High-cost Care Settings [ Time Frame: 1.5 Months ]
Number of visits to ER, urgent care, or hospitalizations because of HS
Time frame: Through study completion, an average of 1.5 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Verbal Consultation, Then Written Action Plan | Visits to High-cost Care Settings [ Time Frame: 1.5 Months ] | 0 Participants |
| Experimental: Written Action Plan | Visits to High-cost Care Settings [ Time Frame: 1.5 Months ] | 0 Participants |