NCT03664271

Brief 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
168

participants targeted

Target at P75+ for not_applicable

Timeline
5mo left

Started Jan 2025

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress76%
Jan 2025Dec 2026

First Submitted

Initial submission to the registry

September 4, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 10, 2018

Completed
6.3 years until next milestone

Study Start

First participant enrolled

January 1, 2025

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

February 14, 2023

Status Verified

February 1, 2023

Enrollment Period

1.9 years

First QC Date

September 4, 2018

Last Update Submit

February 10, 2023

Conditions

Eczema

Keywords

atopic dermatitiseczema

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • change in infant quality of life

    3 month follow-up

  • change in family quality of life

    3 month follow-up

  • change in caregiver knowledge

    3 month follow-up

  • change in child quality of life

    3 month follow-up

Study Arms (3)

in-clinic video intervention

EXPERIMENTAL

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

at home video intervention

ACTIVE COMPARATOR

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

usual care

NO INTERVENTION

Control: Caregivers will not watch the educational video, but will be given access to it at the conclusion of the study.

Interventions

in-clinic video interventionBEHAVIORAL

Video with information about eczema and eczema treatment, to be watched in clinic and at home

in-clinic video intervention
at home video interventionBEHAVIORAL

Video with information about eczema and eczema treatment, to be watched at home only

at home video intervention

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

EczemaDermatitis, Atopic

Condition Hierarchy (Ancestors)

DermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousSkin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Corinna Rea, MD, MPH

    Boston Children's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Corinna Rea, MD, MPH

CONTACT

6173554188corinna.rea@childrens.harvard.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant in Medicine, Principal Investigator, Instructor in Pediatrics

Study Record Dates

First Submitted

September 4, 2018

First Posted

September 10, 2018

Study Start

January 1, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

February 14, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share