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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Verbal Consultation, then Written Action Plan | Other | CONTROL GROUP
|
|
| Experimental: Written Action Plan | Experimental | INTERVENTION GROUP
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Verbal consultation | Behavioral | Verbal consultation only without written information before receiving written action plan |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visits to High-cost Care Settings [ Time Frame: 1.5 Months ] | Number of visits to ER, urgent care, or hospitalizations because of HS | Through study completion, an average of 1.5 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vivian Y Shi, MD | University of Arkansas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72205 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34579620 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Verbal Consultation, Then Written Action Plan | CONTROL GROUP
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 |
| FG001 | Experimental: Written Action Plan | INTERVENTION GROUP
Written Action Plan: Written handout of treatment plan and disease management strategies |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Verbal Consultation, Then Written Action Plan | CONTROL GROUP
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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Visits to High-cost Care Settings [ Time Frame: 1.5 Months ] | Number of visits to ER, urgent care, or hospitalizations because of HS | Posted | Count of Participants | Participants | Through study completion, an average of 1.5 months |
|
Through study completion, an average of 1.5 months.
Not different from clinicaltrials.gov definition
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Verbal Consultation, Then Written Action Plan | CONTROL GROUP
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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Vivian Shi | University of Arkansas for Medical Sciences | 5015266994 | VYShi@uams.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 2, 2020 | Feb 7, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D017497 | Hidradenitis Suppurativa |
| ID | Term |
|---|---|
| D017192 | Skin Diseases, Bacterial |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| Written Action Plan | Behavioral | Written handout of treatment plan and disease management strategies |
|
| BG001 | Experimental: Written Action Plan | INTERVENTION GROUP
Written Action Plan: Written handout of treatment plan and disease management strategies |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
INTERVENTION GROUP
Written Action Plan: Written handout of treatment plan and disease management strategies
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | Experimental: Written Action Plan | INTERVENTION GROUP
Written Action Plan: Written handout of treatment plan and disease management strategies | 0 | 10 | 0 | 10 | 0 | 10 |
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| D012874 | Skin Diseases, Infectious |
| D013492 | Suppuration |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D016575 | Hidradenitis |
| D013543 | Sweat Gland Diseases |