Hidradenitis SuppurativaHSWAPNCT04230291
Hidradenitis Suppurativa Written Action Plan
A study testing Verbal consultation and Written Action Plan in people with Hidradenitis Suppurativa, run by University of Arizona 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 100 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
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2020to 17 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has a diagnosis of HS
Who cannot join
- Has been exposed to a written action plan for HS before
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating the Effect of a Written Action Plan on Comfort and Understanding of Hidradenitis Suppurativa
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 |
| 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
Number of visits to ER, urgent care, or hospitalizations because of HS
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start1 Feb 2020
- Primary completion17 Mar 2020
- Study completion17 Mar 2020
Why it stopped: Principal investigator is not longer at this institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hidradenitis SuppurativaStudies of the same condition, open and under way.
- 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
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Collaborators
- University of Arkansas
- Responsible party
- Principal investigator, Vivian Shi, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04230291
- Sponsor's protocol ID
- 1910019510
- Acronym
- HSWAP
- Status last verified
- Sep 2020
- First submitted
- 13 Jan 2020
- Last updated
- 1 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2020. 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
- NCT04230291
- Acronym / sponsor ID
- HSWAP / 1910019510
- Conditions
- Hidradenitis Suppurativa
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Principal investigator is not longer at this institution
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Collaborators
- University of Arkansas
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 17 Mar 2020 (actual)
- Study completion
- 17 Mar 2020 (actual)
- First posted
- 18 Jan 2020 (actual)
- Results
- Not posted in the source record
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 |
| 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 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Has a diagnosis of HS
Key exclusion criteria (1 listed)
- Has been exposed to a written action plan for HS before
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 | Verbal Consultation, then Written Action Plan, Written Action Plan |
Primary outcome
Visits to high-cost care settings
Time frame: 12 months
Number of visits to ER, urgent care, or hospitalizations because of HS
Results and safety
The study was stopped early (reason given: Principal investigator is not longer at this institution). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2020.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Arizona 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 1 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: stopped early, as of the sponsor's last update on 1 Oct 2020. 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?
The study was stopped early (reason given: Principal investigator is not longer at this institution). Results are not available in the source record.
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: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Oct 2020.