Category
»
Primary study
Registry of Trials»ISRCTN registry
Year
»
2023
INTERVENTION: Randomisation will be carried out by the participant using a secure, online randomisation system. Participants will be randomised 1:1 to either weekly bathing or daily bathing using a minimisation algorithm with a probabilistic element balancing on the following factors: 1. Eczema severity POEM score (3‐7 mild, 8‐16 moderate, 17‐28 severe) 2. Age (<4 years, 4‐11 years, 12‐15 years, 16‐25 years, 26‐55 years, >55 years) 3. Usual method of bathing (bath or not bath) Weekly bathing group: no more than 1 or 2 times per week Daily bathing group: 6 or more times per week Participants will be randomised to either the weekly bathing group or the daily bathing group. Following randomisation, participants will be provided with intervention guidance detailing how often they should bathe according to their allocation, and will be asked to follow this bathing pattern for 4 weeks. Participants will be asked not to change any of their other bathing practices e.g. method of bathing, use of wash products etc. CONDITION: Eczema ; Skin and Connective Tissue Diseases PRIMARY OUTCOME: Eczema symptoms measured using the Patient‐Oriented Eczema Measure (POEM) at baseline and weekly over 4 weeks INCLUSION CRITERIA: 1. Aged =1 year with self‐report of eczema (syn. atopic dermatitis, atopic eczema) 2. Usual residence in the UK 3. Able and willing to give informed consent (or parent/legal guardian able and willing to give informed consent for children under 16 years) SECONDARY OUTCOME: The study will include the Harmonising Outcome Measures for Eczema (HOME) core outcome set (https://www.homeforeczema.org).; ; 1. Itch intensity measured using the Peak Pruritis Numerical Rating Scale (NRS) 22 24‐hour peak itch ‐ one item, scored 0 to 10. Assessed at baseline and 4 weeks. ; 2. Eczema control measured using the Recap of atopic eczema (RECAP) – 7 items, scored 0 to 28. Assessed at baseline and 4 weeks. ; 3. Skin‐specific quality of life measured using the Infants' Dermatitis Quality of Life Inde X(IDQoL) (under 4 years), Children’s Dermatology Life Quality Inde X(CDLQI) (from 4 years to 15 years) or Dermatology Life Quality Inde X(DLQI) (16 years and over), depending on age – 10 items, scored 0 to 30. Assessed at baseline and 4 weeks. ; 4. Use of usual eczema treatments assessed weekly over 4 weeks by questionnaire: ; 4.1. Number of days in the last week flare control creams (topical corticosteroids or calcineurin inhibitors) used – this outcome will be used as an indication of days with eczema flares; 4.2. Number of days in the last week moisturisers (emollients) used; 5. Proportion of participants who achieve an improvement in POEM at week 4 of =3 points compared to baseline; 6. Global change in eczema compared to baseline. Assessed by questionnaire at week 4. ; 7. Adverse events: the researchers do not anticipate adverse events related to changing bathing practices but will collect whether participants changed their eczema treatments or sought advice from a health care provider as a result of a worsening of the eczema. Assessed by questionnaire at week 4.; ; Additional variables will be collected to inform analysis and interpretation of the trial. These include: ; 1. Minimisation variables, prior belief on the frequency of bathing and eczema symptoms, demographics, UK Diagnostic Criteria for Eczema and usual bathing practices (e.g. usual temperature of the water, use of shampoo, use of emollient wash products, and application of emollients/flare control creams after bathing). Assessed by questionnaire at baseline only. ; 2. Number of times had bath or shower in the previous week, assessed by questionnaire weekly over 4 weeks to evaluate adherence to the allocated frequency of bathing routine.; 3. Ease of bathing as allocated, willingness to continue, things that helped or made it difficult to bathe as allocated, and experience of being in the trial (for process evaluation). Assessed by questionnaire at 4 weeks.
Epistemonikos ID: 8bc8608b8408f8e0f8046b35813d712a8f333d53
First added on: Aug 26, 2024