Suspended

Psychodermatologic Educational Modules for Atopic Dermatitis

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What is being tested

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

Behavioral
Who is being recruted

Atopic Dermatitis (AD)

Over 4 Years
+10 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Supportive Care Study

Interventional
Study Start: June 2025

See protocol details

Summary

Principal SponsorUniversity of Alberta
Last updated: August 27, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: June 2, 2025Actual date on which the first participant was enrolled.

This study focuses on evaluating special educational modules designed to help people with atopic dermatitis, also known as eczema, better manage their condition. The modules teach patients about the psychological and physical aspects of living with eczema. The goal is to see if these educational tools can reduce the severity of eczema symptoms and improve the overall quality of life for those affected. This is important because managing the mental and emotional challenges of skin conditions can be just as crucial as treating the physical symptoms. Participants in this study will use these educational modules, which provide information and strategies for dealing with the psychological impact of eczema. The study will observe how well these modules help in reducing the severity of eczema symptoms and improving participants' quality of life. By measuring these outcomes, the study aims to gather evidence on the effectiveness of the educational material, potentially leading to broader access to these resources for people with eczema.

Official TitleEffectiveness of Psychodermatologic Educational Modules on Atopic Dermatitis Patient Outcomes 
Principal SponsorUniversity of Alberta
Last updated: August 27, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
42 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Supportive Care Study
These studies explore ways to improve comfort and daily life for people living with a condition. They may focus on easing symptoms, reducing treatment side effects, or supporting overall well-being.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 4 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Atopic Dermatitis (AD)
Criteria
5 inclusion criteria required to participate
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)

Show More Criteria

5 exclusion criteria prevent from participating
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

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
2 intervention groups 

are designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
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.
Group II
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.
Study Objectives
Primary Objectives

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)
Secondary Objectives

Eczema Disease Severity will be measures using the Patient-Oriented SCORing for Atopic Dermatitis (PO-SCORAD). Scores range between 0 and 103 points (higher score indicative of worse outcomes)

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 3 locations
Suspended
Rao DermatologyEdmonton, CanadaSee the location
Suspended
Kaye Edmonton ClinicEdmonton, Canada
Suspended
Stollery Children's HospitalEdmonton, Canada
Suspended3 Study Centers