A Randomized Controlled Study of Clinic-Based Atopic Dermatitis Therapeutic Patient Education
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Change in the severity of itch
研究概览
简要总结
The primary objective of this randomized trial is to determine whether comprehensive, accessible, and animation-style videos are a more effective method of therapeutic patient education (TPE) based on clinical outcomes than paper handouts in Spanish and English-speaking communities. The clinical outcomes being measured are the severity, sleep affected by atopic dermatitis (AD), and the amount of itch experienced.
详细描述
Patients will be recruited, stratified, and then randomly assigned into one of two intervention groups.The patient participants will be children anywhere on the spectrum of mild to severe AD and they will be stratified into four strata: a) Those with severe AD and no medical intervention escalation, b) Those with mild AD and no medical intervention escalation, c) Those with severe AD and medical intervention escalation, and d) Those with mild AD and medical intervention escalation. Group 1 will be a paper handout for group 1 and an educational video for group 2 as a form of TPE. Subjects will be recruited in clinic after they are screened for AD during their regular dermatology appointment. The research team will provide the patient and parent with a brief introduction to the study, what it involves for the patient, any foreseeable risks, and the compensation. If they agree to participate, a consent/permission form will be given to the parent/guardian to sign. After an initial evaluation of the patient's AD, subjects will receive an initial survey and POEM questionnaire on an iPad via RedCap that will address the condition of their AD. The patient will be administered a form of TPE as the intervention. The intervention will first be viewed/read in clinic, followed by a brief set of questions from the research team to determine the amount of information retained on an immediate level. A follow-up appointment will be scheduled for the patient. Group 2 will receive a slip of paper with a link to the videos, so the TPE will be accessible outside the clinic.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- — 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Boston Medical Center (BMC) patients under the age of 18 diagnosed with AD and their parents/legal guardian
- •Spanish or English speakers
- •Have access to the internet
排除标准
- 未提供
研究组 & 干预措施
Group 1- Printed educational materials
Parent-child dyads randomized to this group will receive printed educational materials in English or Spanish about atopic dermatitis.
干预措施: AD printed educational materials (Other)
Group 2- Educational videos
Parent-child dyads randomized to this group will receive an investigator developed educational video in English or Spanish about atopic dermatitis.
干预措施: AD educational videos (Other)
结局指标
主要结局
Change in the severity of itch
时间窗: baseline, up to 2 months
An investigator developed survey completed by participants with questions about itch will be used to collect data to assess this outcome.
Change in eczema severity based on the Eczema Area and Severity Index (EASI)
时间窗: baseline, up to 2 months
The Eczema Area and Severity Index (EASI) is an investigator-assessed instrument measuring the severity of clinical signs in atopic dermatitis (AD). The suggested severity strata for the EASI are: 0 = clear; 0·1-1·0 = almost clear; 1·1-7·0 = mild; 7·1-21·0 = moderate; 21·1-50·0 = severe; 50·1-72·0 = very severe
Change in eczema severity based on the Patient Oriented Eczema Measure (POEM)
时间窗: baseline, up to 2 months
The Patient Oriented Eczema Measure (POEM) is a validated 7 item instrument with response categories from 0 to 4 where No days = 0, 1-2 days = 1, 3-4 days = 2, 5-6 days = 3, Every day = 4. Scoring for the POEM ranges form 0 to 28 and is interpreted by 0 to 2 = Clear or almost clear, 3 to 7 = Mild eczema, 8 to 16 = Moderate eczema, 17 to 24 = Severe eczema, 25 to 28 = Very severe eczema.
Change in sleep quality
时间窗: baseline, up to 2 months
An investigator developed survey completed by participants with questions about sleep quality will be used to collect data to assess this outcome.
次要结局
- Change in the overall quality of life(baseline, up to 2 months)
- Change in patient/parent confidence(baseline, up to 2 months)
- Change in knowledge of coping with Atopic Dermatitis (AD)(baseline, up to 2 months)
- Satisfaction with therapeutic patient education (TPE)(up to 2 months)
- Atopic Dermatitis related costs(6 months)