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 : September 11, 2018
|Condition or disease||Intervention/treatment||Phase|
|Eczema||Behavioral: in-clinic video intervention Behavioral: at home video intervention||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||168 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomized Controlled Trial of an Educational Eczema Video|
|Estimated Study Start Date :||January 2019|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2020|
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.
- 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)
- 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.
- 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
- 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.
- 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.
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
|Contact: Corinna Rea, MD, MPHfirstname.lastname@example.org|
|Principal Investigator:||Corinna Rea, MD, MPH||Boston Children’s Hospital|