Atopic DermatitisNCT01660217
Eczema Action Plan Improves Patient and Caregiver Understanding and Perception of Atopic Dermatitis Management
A study testing A written Eczema Action Plan (EAP) in people with Atopic Dermatitis, run by Dermatology & Aesthetics of Wicker Park at 1 site in United States.
Trial summary
This is a randomized controlled study. The control group will consist of adult subjects and the caregivers of pediatric subjects with an established diagnosis of atopic dermatitis (AD), who are visiting a dermatologist for a standard AD office visit. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- A written Eczema Action Plan (EAP)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to May 2012
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age 18 or older fulfilling Hanifin and Rajka diagnostic criteria for AD, or adult caregivers for patients younger than 18 years of age, and the ability to comprehend study materials in English
Who cannot join
- Prior exposure to written action plans
Trial locations and contacts
1 site in 1 country.
United States1 site
Dermatology & Aesthetics of Wicker Park
Chicago, Illinois, 60622
About this study
Official title: Eczema Action Plan Improves Patient and Caregiver Understanding and Perception of Atopic Dermatitis Management: A Randomized Controlled Trial
This is a randomized controlled study. The control group will consist of adult subjects and the caregivers of pediatric subjects with an established diagnosis of atopic dermatitis (AD), who are visiting a dermatologist for a standard AD office visit. In the control group, only verbal instruction (VI), the standard of care, will be provided. The intervention group will receive a similar VI with an additional component: an eczema education handout, as well as an individualized written Eczema Action Plan (EAP) that will illustrate how to recognize disease flare-ups and subsequent remissions. In addition, the EAP will provide detailed step-wise instructions regarding treatment modifications for the above-mentioned variations in treatment severity. To ensure that all patients ultimately receive the same level of care, the control group will also receive an EAP at the end of their consultation.
The goal of this study is to assess subjects' perception in the provider's use of an EAP and its effectiveness in helping patients understand their disease and management plan. In order to evaluate the primary end-points, subjects in both the control and treatment groups will be asked to complete post-consultation surveys. Four post-consultation outcomes will be measured: (1) caregivers' understanding of the disease and treatment, (2) caregivers' comfort level in following the EAP at home, (3) caregivers' anxiety level in managing the AD at home, and (4) caregivers' preference for VI + EAP as compared to VI alone, EAP alone, or neither the EAP nor the VI.
- Conditions
- Atopic Dermatitis
- Being tested
- A written Eczema Action Plan (EAP)
- Keywords
- atopic dermatitis, eczema action plan, patient education, written handout, investigator's global assessment, randomized controlled trial
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A written Eczema Action Plan (EAP)Other
A written Eczema Action Plan (EAP) was given to the patients with their treatment regimen.
| Study group | Role | What they receive |
|---|---|---|
| Initial Verbal Instruction Group | Experimental | The group who initially received only verbal instruction, and then later (in the "crossover portion") received a written Eczema Action Plan (EAP) Receives: Other: A written Eczema Action Plan (EAP) |
| Written Eczema Action Plan (EAP) | Experimental | The group given a written EAP after verbal instruction Receives: Other: A written Eczema Action Plan (EAP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants understanding of atopic dermatitis and homecare regimen
Measured: At the beginning of the visit and at the end of the visit (approximately 45min later)
Secondary outcomes (1)
Changes in emotional distress level on disease self-management
Measured: At the beginning of the visit and at the end of the visit (approximately 45min later)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2012 (estimated)
- Study startJun 2011
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dermatology & Aesthetics of Wicker Park
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter A. Lio, MD, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01660217
- Sponsor's protocol ID
- EAP-1
- Status last verified
- Aug 2012
- First submitted
- 31 Jul 2012
- Last updated
- 8 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eczema Action Plan Improves Patient and Caregiver Understanding and Perception of Atopic Dermatitis Management: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01660217
- Acronym / sponsor ID
- EAP-1
- Conditions
- Atopic Dermatitis
- Keywords
- atopic dermatitis, eczema action plan, patient education, written handout, investigator's global assessment, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Dermatology & Aesthetics of Wicker ParkUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 8 Aug 2012 (estimated)
- 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 is a randomized controlled study. The control group will consist of adult subjects and the caregivers of pediatric subjects with an established diagnosis of atopic dermatitis (AD), who are visiting a dermatologist for a standard AD office visit. In the control group, only verbal instruction (VI), the standard of care, will be provided. The intervention group will receive a similar VI with an additional component: an eczema education handout, as well as an individualized written Eczema Action Plan (EAP) that will illustrate how to recognize disease flare-ups and subsequent remissions. In addition, the EAP will provide detailed step-wise instructions regarding treatment modifications for the above-mentioned variations in treatment severity. To ensure that all patients ultimately receive the same level of care, the control group will also receive an EAP at the end of their consultation.
The goal of this study is to assess subjects' perception in the provider's use of an EAP and its effectiveness in helping patients understand their disease and management plan. In order to evaluate the primary end-points, subjects in both the control and treatment groups will be asked to complete post-consultation surveys. Four post-consultation outcomes will be measured: (1) caregivers' understanding of the disease and treatment, (2) caregivers' comfort level in following the EAP at home, (3) caregivers' anxiety level in managing the AD at home, and (4) caregivers' preference for VI + EAP as compared to VI alone, EAP alone, or neither the EAP nor the VI.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Initial Verbal Instruction Group | Experimental | Other: A written Eczema Action Plan (EAP)The group who initially received only verbal instruction, and then later (in the "crossover portion") received a written Eczema Action Plan (EAP) |
| Written Eczema Action Plan (EAP) | Experimental | Other: A written Eczema Action Plan (EAP)The group given a written EAP after verbal instruction |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Age 18 or older fulfilling Hanifin and Rajka diagnostic criteria for AD, or adult caregivers for patients younger than 18 years of age, and the ability to comprehend study materials in English
Key exclusion criteria (1 listed)
- Prior exposure to written action plans
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 |
|---|---|---|
| A written Eczema Action Plan (EAP)A written Eczema Action Plan (EAP) was given to the patients with their treatment regimen. | Other | Initial Verbal Instruction Group, Written Eczema Action Plan (EAP) |
Primary outcome
Participants understanding of atopic dermatitis and homecare regimen
Time frame: At the beginning of the visit and at the end of the visit (approximately 45min later)
1 secondary outcome
Changes in emotional distress level on disease self-management
Time frame: At the beginning of the visit and at the end of the visit (approximately 45min later)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2012.
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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 A written Eczema Action Plan (EAP) in people with Atopic Dermatitis, run by Dermatology & Aesthetics of Wicker Park 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: finished, as of the sponsor's last update on 8 Aug 2012. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Participants understanding of atopic dermatitis and homecare regimen (time frame: At the beginning of the visit and at the end of the visit (approximately 45min later)). 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 8 Aug 2012.