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Educational Eczema Video Intervention

Primary Purpose

Eczema

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
in-clinic video intervention
at home video intervention
Sponsored by
Boston Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Eczema focused on measuring atopic dermatitis, eczema

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Active Comparator

    No Intervention

    Arm Label

    in-clinic video intervention

    at home video intervention

    usual care

    Arm Description

    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.

    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.

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

    Outcomes

    Primary Outcome Measures

    change in eczema severity
    eczema severity as measured by the Patient Oriented Eczema Measure (0-28 range, higher score=worse eczema severity)

    Secondary Outcome Measures

    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.
    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
    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.
    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.

    Full Information

    First Posted
    September 4, 2018
    Last Updated
    February 10, 2023
    Sponsor
    Boston Children's Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03664271
    Brief Title
    Educational Eczema Video Intervention
    Official Title
    Randomized Controlled Trial of an Educational Eczema Video
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 2025 (Anticipated)
    Primary Completion Date
    December 2026 (Anticipated)
    Study Completion Date
    December 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Boston Children's Hospital

    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 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Eczema
    Keywords
    atopic dermatitis, eczema

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    168 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    in-clinic video intervention
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    at home video intervention
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    usual care
    Arm Type
    No Intervention
    Arm Description
    Control: Caregivers will not watch the educational video, but will be given access to it at the conclusion of the study.
    Intervention Type
    Behavioral
    Intervention Name(s)
    in-clinic video intervention
    Intervention Description
    Video with information about eczema and eczema treatment, to be watched in clinic and at home
    Intervention Type
    Behavioral
    Intervention Name(s)
    at home video intervention
    Intervention Description
    Video with information about eczema and eczema treatment, to be watched at home only
    Primary Outcome Measure Information:
    Title
    change in eczema severity
    Description
    eczema severity as measured by the Patient Oriented Eczema Measure (0-28 range, higher score=worse eczema severity)
    Time Frame
    3 month follow-up
    Secondary Outcome Measure Information:
    Title
    change in infant quality of life
    Description
    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.
    Time Frame
    3 month follow-up
    Title
    change in family quality of life
    Description
    family quality of life as measured by the DFI (Dermatitis Family Impact Questionnaire), 0-30 scale with higher score reflecting worse quality of life
    Time Frame
    3 month follow-up
    Title
    change in caregiver knowledge
    Description
    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.
    Time Frame
    3 month follow-up
    Title
    change in child quality of life
    Description
    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.
    Time Frame
    3 month follow-up

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Corinna Rea, MD, MPH
    Phone
    6173554188
    Email
    corinna.rea@childrens.harvard.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Corinna Rea, MD, MPH
    Organizational Affiliation
    Boston Children's Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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