Specialty: Primary Care, Primary sub-specialty: Dermatology
Conditions
Interventions
TEST is a single centre, two-group, individually randomised (1:1) feasibility RCT with economic scoping and nested qualitative study set in primary care in the West of England.
The study will recruit
or told to exclude any food(s) to which they have had a “positive” result.
Of those children with a “positive” result, some will be invited to repeat their SPT, referred for an OFC and/or to undergo
Sponsors
University of Bristol
Eligibility
Sex/Gender
All
Age
3 Months to 5 Years
Inclusion criteria
Inclusion criteria: Children must: 1. Be aged between 3 months and less than 5 years 2. Have eczema diagnosed by an appropriately qualified healthcare professional (registered doctor, nurse or health visitor) 3. Mild, moderate or severe eczema (Patient Orientated Eczema Measure (POEM) score>2) The person giving consent must: 1. Have parental responsibility for the participant 2. Be willing for their child to have allergy skin prick tests (SPTs) and oral food challenges
Exclusion criteria
Exclusion criteria: Child: 1. Medically-diagnosed food allergy or awaiting referral/investigations for possible food allergy 2. Previous investigations for food allergy (does not include home testing) The person responsible for consent: 1. Is unable to give informed consent 2. Has insufficient written English to complete outcome measures 3. Has another child in the family already taking part in the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The feasibility of conducting the trial (recruitment, retention, contamination) and collecting the required data: 1. Recruitment and retention rates compared by method of recruitment and participant characteristics 2. Acceptability of recruitment, intervention and follow-up procedures to parents/carers 3. Acceptability of trial processes and procedures to GPs 4. Development and refining of a manual on the interpretation and dietary advice to be given according to allergy history/skin prick test +/- oral food challenge +/- home dietary trial findings, with accompanying patient information leaflets 5. Number of participants In the intervention group with positive/negative structured allergy histories, skin prick tests and oral food challenges/home dietary trial (where done), to inform estimates for the main trial 6. Adherence to dietary advice 7. Contamination of the control group 8. Acceptability and feasibility of collecting clinical outcomes to determine the primary outcome of the definitive trial 9. Feasibility and optimise collection of patient-level data on NHS and personal resource use 10. Feasibility of using the CHU-9D in children under 5 years of age 11. Inform eligibility criteria for the future definitive trial 12. Detection bias in the collection of patient-reported outcomes 13. Test trial processes and logistics | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Eczema symptoms, measured using POEM at baseline and weeks 4, 8, 12, 16, 20 & 24 2. Eczema signs, measured using EASI at baseline and week 24 3. Eczema ‘bother’ score, measured using single item categorical score 0-10 at baseline and weeks 4, 8, 12, 16, 20 & 24 4. Itch intensity score, measured using single item categorical score 0-10 at baseline and weeks 4, 8, 12, 16, 20 & 24 5. Parent global assessment of eczema, measured using single item categorical score 0-4 at weeks 4, 8, 12, 16, 20 & 24 6. Other possible symptoms of food allergy, measured using unvalidated questionnaire at baseline and weeks 8 and 24 7. UK diagnostic criteria for atopic dermatitis, measured at baseline 8. Main carer anxiety, measured using GAD-7 at baseline & 24 weeks 9. Diet of child and/or mother if child being breastfed by her, measured using unvalidated questionnaire at baseline and weeks 4, 8, 12, 16, 20 & 24 10. Adverse events, measured using unvalidated questions at baseline through to week 24 11. Child and family quality of life, measured using ADQoL, CHU-9D and IDQoL at baseline and weeks 8 and 24 12. Satisfaction with trial processes, procedures and paperwork, measured using unvalidated exit questionnaire at 24 weeks 13. Health services utilisation, measured using unvalidated questionnaire at weeks 4, 8, 12, 16, 20 & 24, and electronic medical record review at week 24 14. Out-of-pocket expenses/time off work, measured using unvalidated questionnaire at weeks 4, 8, 12, 16, 20 & 24 | — |
Countries
England, United Kingdom
Outcome results
None listed