Hidradenitis SuppurativaNCT04600375
Evaluating the Effect of a Written Action Plan on Comfort and Understanding of Hidradenitis Suppurativa
A study testing Verbal consultation and Written Action Plan in people with Hidradenitis Suppurativa, run by University of Arkansas at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Hidradenitis Suppurativa
- What is being tested?
- Verbal consultation and Written Action Plan
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Oct 2020to 7 Dec 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Those who do not fit the inclusion criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
About this study
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.
- Conditions
- Hidradenitis Suppurativa
- Being tested
- Verbal consultation, Written Action Plan
- Medical subject headings
- Hidradenitis Suppurativa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Verbal consultationBehavioural
Verbal consultation only without written information before receiving written action plan
Written Action PlanBehavioural
Written handout of treatment plan and disease management strategies
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Verbal consultation; Behavioral: Written Action Plan |
| Experimental: Written Action Plan | Experimental | INTERVENTION GROUP
1. Survey A
2. Routine clinic visit
3. Verbal consultation AND Written Action Plan
4. Survey C Receives: Behavioral: Written Action Plan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visits to High-cost Care Settings [ Time Frame: 1.5 Months ]
Number of visits to ER, urgent care, or hospitalizations because of HS
Measured: Through study completion, an average of 1.5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2020
- Study start20 Oct 2020
- Primary completion7 Dec 2020
- Study completion7 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hidradenitis SuppurativaStudies of the same condition, open and under way.
- More trials run by University of ArkansasThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vivian Y Shi, MD, Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04600375
- Sponsor's protocol ID
- 261683
- Status last verified
- Feb 2022
- First submitted
- 19 Oct 2020
- Last updated
- 13 Apr 2022
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34579620
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effect of a Written Action Plan on Comfort and Understanding of Hidradenitis Suppurativa
- ClinicalTrials.gov ID
- NCT04600375
- Acronym / sponsor ID
- 261683
- Conditions
- Hidradenitis Suppurativa
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Study start
- 20 Oct 2020 (actual)
- Primary completion
- 7 Dec 2020 (actual)
- Study completion
- 7 Dec 2020 (actual)
- First posted
- 23 Oct 2020 (actual)
- Results
- Posted 6 Apr 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Verbal Consultation, then Written Action Plan | Other | Behavioral: Verbal consultation, Behavioral: Written Action PlanCONTROL 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 |
| Experimental: Written Action Plan | Experimental | Behavioral: Written Action PlanINTERVENTION GROUP 1. Survey A 2. Routine clinic visit 3. Verbal consultation AND Written Action Plan 4. Survey C |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Those who do not fit the inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Verbal consultationVerbal consultation only without written information before receiving written action plan | Behavioural | Verbal Consultation, then Written Action Plan |
| Written Action PlanWritten handout of treatment plan and disease management strategies | Behavioural | Experimental: Written Action Plan, Verbal Consultation, then Written Action Plan |
Primary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34579620Thompson 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vivian Y Shi, MD principal investigator
University of Arkansas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Verbal consultation and Written Action Plan in people with Hidradenitis Suppurativa, run by University of Arkansas at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Apr 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visits to High-cost Care Settings [ Time Frame: 1.5 Months ] (time frame: Through study completion, an average of 1.5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04600375, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2022.