Effectiveness of Psychodermatologic Educational Modules on Atopic Dermatitis Patient Outcomes

NCT07009483 | Active Not Recruiting

• 1 other identifier: Pro00153557
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 3

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.

Conditions

Atopic Dermatitis (AD)

Keywords

Atopic Dermatitis; Dermatology; Psychodermatology; Patient Education

Outcome Measures

Primary Outcomes (1)

• Health-Related Quality of Life

  Quality of Life will be measured using the Dermatology Life Quality Index (DLQI). The scores range from 0 to 30 (higher score indicative of worse outcomes)

  Baseline, 4 weeks, and 12 weeks

Secondary Outcomes (1)

• Eczema Disease Severity

  Baseline, 4 weeks, and 12 weeks

Study Arms (2)

Educational Module Arm

EXPERIMENTAL

This arm consists of participants living with atopic dermatitis that will be trialing our educational modules. In addition to receiving standard medical care, they will be asked to complete these modules throughout the duration of the study period.

Behavioral: Patient education modules providing information on the psychological aspects of atopic dermatitis treatment and management.

Control Arm

NO INTERVENTION

This arm will consist of participants living with atopic dermatitis. They will receive standard medical care, but will not be given access to the educational modules until the study period has been completed.

Interventions

Patient education modules providing information on the psychological aspects of atopic dermatitis treatment and management. BEHAVIORAL

Provision of online patient educational modules (in addition to patients receiving regular clinical action/ appointments at the Kaye Edmonton Clinic, the Stollery Children's Hospital, and the Rao Dermatology Clinic for Atopic Dermatitis).

Educational Module Arm

Eligibility Criteria

• Age: 4 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (3)

Rao Dermatology

Edmonton, Alberta, T6G 1C3, Canada

Location

Kaye Edmonton Clinic

Edmonton, Alberta, T6G 1Z1, Canada

Location

Stollery Children's Hospital

Edmonton, Alberta, T6G 2B7, Canada

Location

Related Publications (7)

• 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.

  PMID: 36739386 BACKGROUND

• 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.

  PMID: 38205736 BACKGROUND

• 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.

  PMID: 38807447 BACKGROUND

• 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.

  PMID: 34039041 BACKGROUND

• 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.

  PMID: 30838645 BACKGROUND

• 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.

  PMID: 30025911 BACKGROUND

• 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.

  PMID: 25521458 BACKGROUND

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Marlene Dytoc, MD, PhD, FRCPC

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2025
• First Posted: June 6, 2025
• Study Start: June 2, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 27, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (3)