Efficacy of Targeted Intervention for Topical Steroid Phobia.

Adherence, Medication Clinical Trial

Official title:

A Randomised Controlled Trial Assessing the Efficacy of Targeted Intervention for Topical Steroid Phobia.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03658252
• Other study ID #: 2018/00481
• Status: Completed
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: May 4, 2019

Study information

• Verified date: February 2020
• Source: National University Health System, Singapore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Topical steroids are an important component of treatment for many dermatological conditions, however 'Corticosteroid phobia' is a significant factor contributing to non adherence to prescribed therapy.

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.

Description:

Oral and topical steroids are commonly prescribed in the dermatological setting for its anti inflammatory property, for conditions ranging from eczematous disease, autoimmune disorders and many other primary dermatoses.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 270
• Est. completion date: May 4, 2019
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

Participants aged 21 years and above. Currently prescribed and expected to be on topical steroids for the next 3 months.

Willing to provide telephone number or email address, and to be recontacted. Able to read and understand english.

Exclusion Criteria:

Not on topical steroids. Unable to understand english. Unable or unwilling to be contacted for follow up surveys.

Related Conditions & MeSH terms

• Adherence, Medication
• Dermatologic Disease
• Phobia
• Phobic Disorders
• Skin Diseases

Intervention

Behavioral:
• 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

Locations

Country	Name	City	State
Singapore	National University Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
National University Health System, Singapore

Country where clinical trial is conducted

Singapore, 

References & Publications (3)

Dréno 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. — View Citation

Moret L, Anthoine E, Aubert-Wastiaux H, Le Rhun A, Leux C, Mazereeuw-Hautier J, Stalder JF, Barbarot S. TOPICOP©: 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. — View Citation

Pawin H, Beylot C, Chivot M, Faure M, Poli F, Revuz J, Dréno 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in TOPICOP© score at 3 months	Validated score assessing topical corticosteroid (TCS) phobia. It consists of 12 items assessing three domains of TCS phobia, knowledge and beliefs, fears and behaviour on a 4 point likert scale. The individual domain and global scores are calculated as a percentage of the total score. A higher score indicated greater steroid phobia.	3 months
Secondary	Change in TOPICOP© score at 1 month	Validated score assessing topical corticosteroid (TCS) phobia. It consists of 12 items assessing three domains of TCS phobia, knowledge and beliefs, fears and behaviour on a 4 point likert scale. The individual domain and global scores are calculated as a percentage of the total score. A higher score indicated greater steroid phobia.	1 month
Secondary	Change in ECOB (Elaboration d'un outil d'evaluation de l'observance des traitements médicamenteux) score at 1 month	Score comprising 4 questions to assess patients awareness of their medication and compliance. Questions administered in english. Designed initially to assess adherence to topical and oral therapies in acne, but is used in this study to assess adherence to topical steroids. Range of total score is from 0-4. A score of 4 classifies the patient as adherent, and <4 as non adherent.	1 month
Secondary	Change in ECOB (Elaboration d'un outil d'evaluation de l'observance des traitements médicamenteux) score at 3 month	Score comprising 4 questions to assess patients awareness of their medication and compliance. Questions administered in english. Designed initially to assess adherence to topical and oral therapies in acne, but is used in this study to assess adherence to topical steroids. Range of total score is from 0-4. A score of 4 classifies the patient as adherent, and <4 as non adherent.	3 month
Secondary	Change in Dermatology Life Quality Index score at 1 month	Dermatology specific quality of life instrument. A 10 point questionnaire, with a total score range from 0 to 30. A higher score indicated greater impact on quality of life.	1 month
Secondary	Change in Dermatology Life Quality Index score at 3 month	Dermatology specific quality of life instrument. A 10 point questionnaire, with a total score range from 0 to 30. A higher score indicated greater impact on quality of life.	3 month