Educational Eczema Video Intervention

Eczema Clinical Trial

Official title:

Randomized Controlled Trial of an Educational Eczema Video

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03664271
• Other study ID #: P00029896
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2025
• Est. completion date: December 2026

Study information

• Verified date: February 2023
• Source: Boston Children's Hospital
• Contact: Corinna Rea, MD, MPH
• Phone: 6173554188
• Email: corinna.rea[@]childrens.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 168
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Eczema

Intervention

Behavioral:
• in-clinic video intervention
Video with information about eczema and eczema treatment, to be watched in clinic and at home
• at home video intervention
Video with information about eczema and eczema treatment, to be watched at home only

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boston Children's Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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