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Educational Eczema Video Intervention

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ClinicalTrials.gov Identifier: NCT03664271
Recruitment Status : Not yet recruiting
First Posted : September 10, 2018
Last Update Posted : June 14, 2019
Sponsor:
Information provided by (Responsible Party):
Corinna Rea, Boston Children’s Hospital

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.

Condition or disease Intervention/treatment Phase
Eczema Behavioral: in-clinic video intervention Behavioral: at home video intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 168 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of an Educational Eczema Video
Estimated Study Start Date : January 2020
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

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.



Primary Outcome Measures :
  1. change in eczema severity [ Time Frame: 3 month follow-up ]
    eczema severity as measured by the Patient Oriented Eczema Measure (0-28 range, higher score=worse eczema severity)


Secondary Outcome Measures :
  1. change in infant quality of life [ Time Frame: 3 month follow-up ]
    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.

  2. change in family quality of life [ Time Frame: 3 month follow-up ]
    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. change in caregiver knowledge [ Time Frame: 3 month follow-up ]
    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.

  4. change in child quality of life [ Time Frame: 3 month follow-up ]
    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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03664271


Contacts
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Contact: Corinna Rea, MD, MPH 6173554188 corinna.rea@childrens.harvard.edu

Sponsors and Collaborators
Boston Children’s Hospital
Investigators
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Principal Investigator: Corinna Rea, MD, MPH Boston Children’s Hospital

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Responsible Party: Corinna Rea, Assistant in Medicine, Principal Investigator, Instructor in Pediatrics, Boston Children’s Hospital
ClinicalTrials.gov Identifier: NCT03664271     History of Changes
Other Study ID Numbers: P00029896
First Posted: September 10, 2018    Key Record Dates
Last Update Posted: June 14, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Corinna Rea, Boston Children’s Hospital:
atopic dermatitis
eczema

Additional relevant MeSH terms:
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Eczema
Dermatitis
Skin Diseases
Skin Diseases, Eczematous