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Completed

NCT Number: NCT04352270

Clinic-Based Atopic Dermatitis Therapeutic Patient Education

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.

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Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

Up to 17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

BMC Pediatric Dermatology Clinics

Boston, Massachusetts, 02118, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AD printed educational materials

Other

Printed educational materials in Spanish and English about coping with Atopic Dermatitis, specifically geared towards children and parents will be given to participants.

AD educational videos

Other

Short, educational videos in English and Spanish about coping with Atopic Dermatitis, specifically geared towards children and parents will be developed. There will be Spanish and English versions of the videos, minimal text, comprehensive language, animations, and it will be administered via user friendly platforms or websites.

Primary outcomes

  1. Change in eczema severity based on the Patient Oriented Eczema Measure (POEM)

    Time frame: 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.

  2. Change in eczema severity based on the Eczema Area and Severity Index (EASI)

    Time frame: 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

  3. Change in the severity of itch

    Time frame: 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.

  4. Change in sleep quality

    Time frame: 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.

Secondary outcomes

  1. Change in the overall quality of life

    Time frame: baseline, up to 2 months

    An investigator developed survey completed by participants with questions about quality of life will be used to collect data to assess this outcome.

  2. Change in patient/parent confidence

    Time frame: baseline, up to 2 months

    An investigator developed survey completed by participants with questions about confidence will be used to collect data to assess this outcome.

  3. Change in knowledge of coping with Atopic Dermatitis (AD)

    Time frame: baseline, up to 2 months

    An investigator developed survey completed by participants with questions about their knowledge of coping with AD will be used to collect data to assess this outcome.

  4. Satisfaction with therapeutic patient education (TPE)

    Time frame: up to 2 months

    An investigator developed survey completed by participants with questions about their satisfaction about TPE will be used to collect data to assess this outcome.

  5. Atopic Dermatitis related costs

    Time frame: 6 months

    Billing records will be analyzed to assess AD related costs.

Sponsors and collaborators

Lead sponsor

Boston University

Other

Registry information

Official study title

A Randomized Controlled Study of Clinic-Based Atopic Dermatitis Therapeutic Patient Education

Acronym: AD-TPE

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Apr 20, 2020
Registry last updated
Mar 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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