Clinic-Based Atopic Dermatitis Therapeutic Patient Education (AD-TPE)
Primary Purpose
Atopic Dermatitis
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
AD printed educational materials
AD educational videos
Sponsored by
About this trial
This is an interventional health services research trial for Atopic Dermatitis focused on measuring Therapeutic patient education, Printed handouts, Educational videos, Child-parent dyads
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
Sites / Locations
- BMC Pediatric Dermatology ClinicsRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Group 1- Printed educational materials
Group 2- Educational videos
Arm Description
Parent-child dyads randomized to this group will receive printed educational materials in English or Spanish about atopic dermatitis.
Parent-child dyads randomized to this group will receive an investigator developed educational video in English or Spanish about atopic dermatitis.
Outcomes
Primary Outcome Measures
Change in eczema severity based on the Patient Oriented Eczema Measure (POEM)
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 eczema severity based on the Eczema Area and Severity Index (EASI)
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 the severity of itch
An investigator developed survey completed by participants with questions about itch will be used to collect data to assess this outcome.
Change in sleep quality
An investigator developed survey completed by participants with questions about sleep quality will be used to collect data to assess this outcome.
Secondary Outcome Measures
Change in the overall quality of life
An investigator developed survey completed by participants with questions about quality of life will be used to collect data to assess this outcome.
Change in patient/parent confidence
An investigator developed survey completed by participants with questions about confidence will be used to collect data to assess this outcome.
Change in knowledge of coping with Atopic Dermatitis (AD)
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.
Satisfaction with therapeutic patient education (TPE)
An investigator developed survey completed by participants with questions about their satisfaction about TPE will be used to collect data to assess this outcome.
Atopic Dermatitis related costs
Billing records will be analyzed to assess AD related costs.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04352270
Brief Title
Clinic-Based Atopic Dermatitis Therapeutic Patient Education
Acronym
AD-TPE
Official Title
A Randomized Controlled Study of Clinic-Based Atopic Dermatitis Therapeutic Patient Education
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 27, 2023 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
Keywords
Therapeutic patient education, Printed handouts, Educational videos, Child-parent dyads
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
560 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group 1- Printed educational materials
Arm Type
Active Comparator
Arm Description
Parent-child dyads randomized to this group will receive printed educational materials in English or Spanish about atopic dermatitis.
Arm Title
Group 2- Educational videos
Arm Type
Experimental
Arm Description
Parent-child dyads randomized to this group will receive an investigator developed educational video in English or Spanish about atopic dermatitis.
Intervention Type
Other
Intervention Name(s)
AD printed educational materials
Intervention Description
Printed educational materials in Spanish and English about coping with Atopic Dermatitis, specifically geared towards children and parents will be given to participants.
Intervention Type
Other
Intervention Name(s)
AD educational videos
Intervention Description
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 Outcome Measure Information:
Title
Change in eczema severity based on the Patient Oriented Eczema Measure (POEM)
Description
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.
Time Frame
baseline, up to 2 months
Title
Change in eczema severity based on the Eczema Area and Severity Index (EASI)
Description
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
Time Frame
baseline, up to 2 months
Title
Change in the severity of itch
Description
An investigator developed survey completed by participants with questions about itch will be used to collect data to assess this outcome.
Time Frame
baseline, up to 2 months
Title
Change in sleep quality
Description
An investigator developed survey completed by participants with questions about sleep quality will be used to collect data to assess this outcome.
Time Frame
baseline, up to 2 months
Secondary Outcome Measure Information:
Title
Change in the overall quality of life
Description
An investigator developed survey completed by participants with questions about quality of life will be used to collect data to assess this outcome.
Time Frame
baseline, up to 2 months
Title
Change in patient/parent confidence
Description
An investigator developed survey completed by participants with questions about confidence will be used to collect data to assess this outcome.
Time Frame
baseline, up to 2 months
Title
Change in knowledge of coping with Atopic Dermatitis (AD)
Description
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.
Time Frame
baseline, up to 2 months
Title
Satisfaction with therapeutic patient education (TPE)
Description
An investigator developed survey completed by participants with questions about their satisfaction about TPE will be used to collect data to assess this outcome.
Time Frame
up to 2 months
Title
Atopic Dermatitis related costs
Description
Billing records will be analyzed to assess AD related costs.
Time Frame
6 months
10. Eligibility
Sex
All
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Margaret Lee, MD PhD
Phone
(617) 638-5500
Email
Margaret.Lee@bmc.org
First Name & Middle Initial & Last Name or Official Title & Degree
Courtney Hanna, MD
Phone
(617) 358-9700
Email
channa1@bu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Margaret Lee, MD PhD
Organizational Affiliation
Boston University
Official's Role
Principal Investigator
Facility Information:
Facility Name
BMC Pediatric Dermatology Clinics
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Margaret Lee, MD PhD
Phone
617-638-5500
Email
Margaret.Lee@bmc.org
12. IPD Sharing Statement
Plan to Share IPD
No
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Clinic-Based Atopic Dermatitis Therapeutic Patient Education
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