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Clinical Trials/NCT03658252
NCT03658252
Completed
Not Applicable

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

National University Health System, Singapore1 site in 1 country270 target enrollmentOctober 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Dermatologic Disease
Sponsor
National University Health System, Singapore
Enrollment
270
Locations
1
Primary Endpoint
Change in TOPICOP© score at 3 months
Status
Completed
Last Updated
6 years ago

Overview

Brief 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.

Detailed 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.

Registry
clinicaltrials.gov
Start Date
October 1, 2018
End Date
May 4, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
National University Health System, Singapore
Responsible Party
Principal Investigator
Principal Investigator

Ellie Choi

Senior Resident, Division of Dermatology, Department of Medicine, Principal Investigator

National University Health System, Singapore

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Change in TOPICOP© score at 3 months

Time Frame: 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.

Secondary Outcomes

  • Change in TOPICOP© score at 1 month(1 month)
  • Change in ECOB (Elaboration d'un outil d'evaluation de l'observance des traitements médicamenteux) score at 3 month(3 month)
  • Change in Dermatology Life Quality Index score at 1 month(1 month)
  • Change in Dermatology Life Quality Index score at 3 month(3 month)
  • Change in ECOB (Elaboration d'un outil d'evaluation de l'observance des traitements médicamenteux) score at 1 month(1 month)

Study Sites (1)

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