Efficacy of Targeted Intervention for Topical Steroid Phobia.
NCT ID: NCT03658252
Last Updated: 2020-02-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
270 participants
INTERVENTIONAL
2018-10-01
2019-05-04
Brief Summary
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The primary aim of this study is to determine the effectiveness of targeted education, and involvement in a moderated social forum in reducing steroid phobia as assessed by the TOPICOP© score. Secondary objectives include determining if a decrease in TOPICOP© score correlates to an increase in compliance, or an improvement in quality of life.
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Detailed Description
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There is large evidence that topical steroids are safe in the long term when used appropriately, and the benefits of reducing skin inflammation outweigh their risks of skin atrophy and telangiectasia.
Topical corticosteroid phobia (TCS phobia) toward topical steroids is a significant factor contributing to non adherence. Much of this may be attributed to the excessive or exaggerated propagation of 'steroid phobia' messages from the internet, family/friends, and even medical professionals.
The TOPICOP© score is the first, and presently only score that is validated to explore TCS phobia. It consists of 12 items assessing three domains of TCS phobia, knowledge and beliefs, fears and behavior. Responses are graded with a 4 point Likert scale.
The primary aim of this study is to determine the effectiveness of targeted education, and involvement in a moderated social forum in reducing steroid phobia as assessed by the TOPICOP© score. Secondary objectives include determining if reduction in steroid phobia correlates to an increase in compliance, or an improvement in quality of life.
The investigators hypothesise that providing information directed at common misconceptions towards topical steroids will decrease steroid phobia, and that this would result in improved adherence and quality of life. Providing access to moderated forums with balanced views and information may also help to address concerns of patients.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
TRIPLE
Study Groups
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Intervention
Participants in the intervention arm will be shown a 2 minute educational video, and given an information leaflet on topical steroids. At 1 month of follow up, a link encouraging participants to sign up for a pre-selected, disease specific, moderated online support group would be sent to their emails.
Participants will continue to receive standard medical care and counselling by their dermatologists as clinically indicated.
Targeted education
Educational video developed by the hospital, addressing common misconceptions of topical steroids. A patient information leaflet on topical steroids
Online disease specific forum
An invitation to join an online moderated disease specific social forum
Control
Patients in the control arm will receive only standard medical care and counseling by their dermatologist as clinically indicated.
No interventions assigned to this group
Interventions
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Targeted education
Educational video developed by the hospital, addressing common misconceptions of topical steroids. A patient information leaflet on topical steroids
Online disease specific forum
An invitation to join an online moderated disease specific social forum
Eligibility Criteria
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Inclusion Criteria
Willing to provide telephone number or email address, and to be recontacted. Able to read and understand english.
Exclusion Criteria
21 Years
ALL
No
Sponsors
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National University Health System, Singapore
OTHER
Responsible Party
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Ellie Choi
Senior Resident, Division of Dermatology, Department of Medicine, Principal Investigator
Principal Investigators
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Ellie Choi, MBBS, MRCP, MMed (IM)
Role: PRINCIPAL_INVESTIGATOR
National University Healthcare System
Chris Tan, MBBS, FAMS
Role: STUDY_DIRECTOR
National University Healthcare System
Nisha Chandran, MBBS, MRCP, MMed (IM)
Role: STUDY_DIRECTOR
National University Healthcare System
Locations
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National University Hospital
Singapore, , Singapore
Countries
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References
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Pawin H, Beylot C, Chivot M, Faure M, Poli F, Revuz J, Dreno B. Creation of a tool to assess adherence to treatments for acne. Dermatology. 2009;218(1):26-32. doi: 10.1159/000165628. Epub 2008 Oct 22.
Dreno B, Thiboutot D, Gollnick H, Finlay AY, Layton A, Leyden JJ, Leutenegger E, Perez M; Global Alliance to Improve Outcomes in Acne. Large-scale worldwide observational study of adherence with acne therapy. Int J Dermatol. 2010 Apr;49(4):448-56. doi: 10.1111/j.1365-4632.2010.04416.x.
Moret L, Anthoine E, Aubert-Wastiaux H, Le Rhun A, Leux C, Mazereeuw-Hautier J, Stalder JF, Barbarot S. TOPICOP(c): a new scale evaluating topical corticosteroid phobia among atopic dermatitis outpatients and their parents. PLoS One. 2013 Oct 16;8(10):e76493. doi: 10.1371/journal.pone.0076493. eCollection 2013.
Other Identifiers
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2018/00481
Identifier Type: -
Identifier Source: org_study_id
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