Educational Eczema Video Intervention

Randomized Controlled Trial of an Educational Eczema Video

The objectives of this study are to increase families' understanding of eczema and improve eczema management in the primary care setting. The investigators plan to create an educational video for families providing general information about eczema as well as instructions about good skincare management and common treatments. The investigators will conduct a randomized controlled trial of the plan in the primary care clinic at Boston Children's Hospital. Specifically, the investigators aim to (1) decrease eczema severity (2) improve patient and family quality of life (QOL) and (3) increase parental knowledge about eczema and eczema management.

Study Overview

• Status: Not yet recruiting
• Conditions: Eczema
• Intervention / Treatment: Behavioral: in-clinic video intervention; Behavioral: at home video intervention

• Study Type: Interventional
• Enrollment (Anticipated): 168
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:Eligibility criteria include the following:

• accompanying adult speaks English
• patient has a history of eczema
• patient is between the ages of 1 month and 16 years
• accompanying adult is a primary caregiver
• child is not in foster care
• accompanying adult is 18 years old or older.

Exclusion Criteria:

• accompanying adult does not speak English
• accompanying adult is not the primary caregiver
• accompanying adult is not 18 years old or older
• patient is in foster care

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: in-clinic video intervention; Intervention: Caregivers will watch an educational video in clinic, and also be given information about how to access the video from home (ideal condition). The intervention video will contain educational information about eczema, as well as routine skincare and common treatments.	Behavioral: in-clinic video intervention; Video with information about eczema and eczema treatment, to be watched in clinic and at home
ACTIVE_COMPARATOR: at home video intervention; Intervention: Caregivers will be given information about how to watch the video at home, but will not watch it in clinic (real-world condition).The intervention video will contain educational information about eczema, as well as routine skincare and common treatments.	Behavioral: at home video intervention; Video with information about eczema and eczema treatment, to be watched at home only
NO_INTERVENTION: usual care; Control: Caregivers will not watch the educational video, but will be given access to it at the conclusion of the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in eczema severity	eczema severity as measured by the Patient Oriented Eczema Measure (0-28 range, higher score=worse eczema severity)	3 month follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in infant quality of life	infant quality of life as measured by the IDQOL (Infant's Dermatitis Quality of Life Index), uses a 0-30 scale, with a higher number reflecting worse quality of life. Used for children <4 years of age.	3 month follow-up
change in family quality of life	family quality of life as measured by the DFI (Dermatitis Family Impact Questionnaire), 0-30 scale with higher score reflecting worse quality of life	3 month follow-up
change in caregiver knowledge	change in caregiver knowledge pre-post as assessed by a questionnaire. This is not a standardized tool, but rather a series of 22 questions about caregiver comfort and understanding of eczema. Some responses use a likert scale format, while others are multiple choice questions. There are 8 multiple choice questions, each of which has one right answer. Those can be totaled to determine percentage correct.	3 month follow-up
change in child quality of life	child quality of life as measured by the CDLQI (Children's Dermatology Life Quality Index), uses a 0-30 scale, with a higher number reflecting worse quality of life. Used for children age 4-16.	3 month follow-up

Collaborators and Investigators

• Sponsor: Boston Children's Hospital

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): January 1, 2025
• Primary Completion (ANTICIPATED): December 1, 2026
• Study Completion (ANTICIPATED): December 1, 2026

Study Registration Dates

• First Submitted: September 4, 2018
• First Submitted That Met QC Criteria: September 6, 2018
• First Posted (ACTUAL): September 10, 2018

Study Record Updates

• Last Update Posted (ESTIMATE): February 14, 2023
• Last Update Submitted That Met QC Criteria: February 10, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: atopic dermatitis; eczema
• Additional Relevant MeSH Terms: Skin Diseases; Dermatitis; Skin Diseases, Eczematous; Eczema
• Other Study ID Numbers: P00029896

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No