Clinical trial NCT04352270: Clinic-Based Atopic Dermatitis Therapeutic Patient Education
Official title: A Randomized Controlled Study of Clinic-Based Atopic Dermatitis Therapeutic Patient Education
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atopic Dermatitis
Keywords: Therapeutic patient education
Printed handouts
Educational videos
Child-parent dyads
Lead sponsor: Boston University
Sponsor class: OTHER
First posted: 2020-04-20
Enrollment: 56
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* None

Primary outcomes:
measure: Change in eczema severity based on the Patient Oriented Eczema Measure (POEM)
timeFrame: baseline, up to 2 months
measure: Change in eczema severity based on the Eczema Area and Severity Index (EASI)
timeFrame: baseline, up to 2 months
measure: Change in the severity of itch
timeFrame: baseline, up to 2 months
measure: Change in sleep quality
timeFrame: baseline, up to 2 months
Secondary outcomes:
measure: Change in the overall quality of life
timeFrame: baseline, up to 2 months
measure: Change in patient/parent confidence
timeFrame: baseline, up to 2 months
measure: Change in knowledge of coping with Atopic Dermatitis (AD)
timeFrame: baseline, up to 2 months
measure: Satisfaction with therapeutic patient education (TPE)
timeFrame: up to 2 months
measure: Atopic Dermatitis related costs
timeFrame: 6 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: BMC Pediatric Dermatology Clinics
state: Massachusetts
Study officials:
affiliation: Boston University
name: Margaret Lee, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: