Clinical trial NCT07009483: Effectiveness of Psychodermatologic Educational Modules on Atopic Dermatitis Patient Outcomes: A Randomized Controlled Trial
Official title: Effectiveness of Psychodermatologic Educational Modules on Atopic Dermatitis Patient Outcomes: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Atopic Dermatitis (AD)
Keywords: Atopic Dermatitis
Dermatology
Psychodermatology
Patient Education
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2025-06-06
Enrollment: 42
Sex: ALL
Minimum age (years): 4
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: In a previous part of this study, we created educational modules about the psychodermatology of inflammatory skin conditions, with a particular emphasis on atopic dermatitis, for patients. These modules will empower patients to better manage both the psychological and physical aspects of their skin conditions. As part of this project, we aim to conduct a clinical trial to determine the effectiveness of these modules on eczema severity and health-related quality of life in patients. We hope to use these findings to develop and disseminate accessible educational material on the psychological aspects of dermatologic care.


Eligibility criteria: Inclusion Criteria:

1. New diagnosis or follow-up for previous diagnosis of Atopic Dermatitis.
2. Reliable internet access to be able to access the e-modules.
3. Able to speak English at a level required to understand the content of this study.
4. Child participants will be included in this study contingent on the consent of their guardian/caregiver(s).
5. Age range of eligible participants: Age 4 years and older.

Exclusion Criteria:

1. Does not have a new diagnosis or follow-up for previous diagnosis of Atopic Dermatitis.
2. Unable to access and/or navigate e-modules with reasonable support/instruction.
3. Unable to speak English at a level required to understand the content of this study.
4. Unable to provide informed consent.
5. Less than 4 years of age.

Primary outcomes:
measure: Health-Related Quality of Life
timeFrame: Baseline, 4 weeks, and 12 weeks
Secondary outcomes:
measure: Eczema Disease Severity
timeFrame: Baseline, 4 weeks, and 12 weeks
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Rao Dermatology
state: Alberta
city: Edmonton
country: Canada
facility: Kaye Edmonton Clinic
state: Alberta
city: Edmonton
country: Canada
facility: Stollery Children's Hospital
state: Alberta
Study officials:
affiliation: University of Alberta
name: Marlene Dytoc, MD, PhD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
citation: Liu C, Chan M, Beard V, Mathura P, Dytoc M. Beyond Skin Deep: case-based online modules to teach multidisciplinary care in dermatology among clerkship students. BMC Med Educ. 2023 Feb 4;23(1):90. doi: 10.1186/s12909-023-04072-z.
citation: Verma L, Turk T, Dennett L, Dytoc M. Teledermatology in Atopic Dermatitis: A Systematic Review. J Cutan Med Surg. 2024 Mar-Apr;28(2):153-157. doi: 10.1177/12034754231223694. Epub 2024 Jan 11.
citation: Odeshi O, Turk T, Fiorillo L, Lowe S, Dytoc M. Teledermatology Versus In-Person Visits for the Follow-Up of Atopic Dermatitis Patients. J Cutan Med Surg. 2024 Jul-Aug;28(4):346-351. doi: 10.1177/12034754241253192. Epub 2024 May 28.
citation: Turk T, Fujiwara E, Abba-Aji A, Mathura P, Dytoc M. Psychodermatology in Canada: A National Survey Assessment of Dermatologists' Perception, Practice Patterns, and Challenges. J Cutan Med Surg. 2021 May-Jun;25(3):249-256. doi: 10.1177/1203475420977473. Epub 2020 Dec 2.
citation: Silverberg JI, Gelfand JM, Margolis DJ, Boguniewicz M, Fonacier L, Grayson MH, Ong PY, Chiesa Fuxench ZC, Simpson EL. Symptoms and diagnosis of anxiety and depression in atopic dermatitis in U.S. adults. Br J Dermatol. 2019 Sep;181(3):554-565. doi: 10.1111/bjd.17683. Epub 2019 Mar 5.
citation: Silverberg JI, Gelfand JM, Margolis DJ, Boguniewicz M, Fonacier L, Grayson MH, Simpson EL, Ong PY, Chiesa Fuxench ZC. Patient burden and quality of life in atopic dermatitis in US adults: A population-based cross-sectional study. Ann Allergy Asthma Immunol. 2018 Sep;121(3):340-347. doi: 10.1016/j.anai.2018.07.006. Epub 2018 Jul 16.
citation: Dalgard FJ, Gieler U, Tomas-Aragones L, Lien L, Poot F, Jemec GBE, Misery L, Szabo C, Linder D, Sampogna F, Evers AWM, Halvorsen JA, Balieva F, Szepietowski J, Romanov D, Marron SE, Altunay IK, Finlay AY, Salek SS, Kupfer J. The psychological burden of skin diseases: a cross-sectional multicenter study among dermatological out-patients in 13 European countries. J Invest Dermatol. 2015 Apr;135(4):984-991. doi: 10.1038/jid.2014.530. Epub 2014 Dec 18.