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Purpose: Evaluate the impact of cleaning the bathroom environment on the severity of eczema. Determine if part of the efficacy of bleach baths may be in cleaning the bathroom. Record data on the process in order to improve future interventions.
Participants: Patients and families with eczema
Procedures (methods):
The study will evaluate the effect of two interventions.
There will be four quantitative assessment phases:
There will be one qualitative assessment:
Additionally, the study team will keep field notes documenting perceptions and experiences during the cleaning process. These qualitative documents will be used for process evaluation to improve home hygiene interventions and studies. Domains that the investigators will assess in field notes include:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No cleaning (control) | No Intervention | Patients will have a bacterial culture taken from their bathtub and then continue regular care. We will offer to clean their bathrooms after the 4 week intervention period ends. | |
| Bubbles | Experimental | Patients will have a bacterial culture taken from their bathtub and have their bathrooms cleaned by the investigators |
|
| Bleach and Bubbles | Active Comparator | Patients will have a bacterial culture taken from their bathtub, have their bathrooms cleaned by the investigators, and be given instructions to perform bleach baths twice weekly. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bubbles | Other | All bathrooms with showers or bathtubs will be cleansed with simple products (dilute bleach, dilute white vinegar, baking soda, and dilute Dawn dish soap) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Absolute change in POEM score From Baseline (day 0) to Week 4 (day 28) | POEM is a 7-item questionnaire that assesses disease symptoms (dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping) with a scoring system of 0 (absent disease) to 28 (severe disease). A higher POEM score correlates with a poorer quality of life (QOL). | Baseline (day 0) to Week 4 (day 28) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Craig N Burkhart, MD | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27516 | United States |
The investigators may share deidentified individual data that supports the results. This may include the study protocol, the statistical analysis plan, and/or the spreadsheet used to collect data.
The data will be available beginning 9 to 36 months following publication provided the investigator meets the appropriate access criteria.
Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
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| ID | Term |
|---|---|
| D004485 | Eczema |
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
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| ID | Term |
|---|---|
| D015905 | Gastric Balloon |
| ID | Term |
|---|---|
| D004864 | Equipment and Supplies |
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| Bleach and Bubbles | Other | All bathrooms with showers or bathtubs will be cleansed with simple products (dilute bleach, dilute white vinegar, baking soda, and dilute Dawn dish soap). |
|
|
| D012873 |
| Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |