Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03658252
Other study ID # 2018/00481
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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 TOPICOPĀ© 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 TOPICOPĀ© 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.

Study Design


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
See also
  Status Clinical Trial Phase
Recruiting NCT05546931 - Mobile Health Program for Rural Hypertension N/A
Recruiting NCT04316715 - Life-Steps Counseling to Enhance Adherence and Engagement in PrEP Care N/A
Active, not recruiting NCT04602468 - Real World Clinical Outcomes With Novel Modulator Therapy Combinations in People With CF (RECOVER) Phase 4
Active, not recruiting NCT04588883 - Strengthening Families Living With HIV in Kenya N/A
Enrolling by invitation NCT04676204 - Relationship Between Oral DMT Burden and Adherence in MS
Not yet recruiting NCT03807388 - ReMindCare App for Patients From First Episode of Psychosis Unit. N/A
Completed NCT05168449 - The Impact of Pharmacist-led Mobile Application on Adherence in Chronic Kidney Disease Patients N/A
Active, not recruiting NCT04612088 - Intervention for Multivitamin Adherence on Bariatric Patients N/A
Completed NCT03958331 - Behavioral Economics and Adherence in Teens (BEAT!) N/A
Completed NCT05233644 - Medication Adherence in Heart Failure After Hospitalisation
Completed NCT03837496 - Small-group, Virtual Program for Improving Symptoms and Distress Related to Hormonal Therapy for Breast Cancer Survivors N/A
Recruiting NCT03683966 - MigALastat Therapy Adherence Among FABRY Patients: A Prospective Multicentral Observational Study
Withdrawn NCT04754867 - Pre-Test of For the Future Self and Smoking Cessation N/A
Recruiting NCT05996094 - Antiretroviral Adherence and Drug-level Monitoring
Not yet recruiting NCT06056037 - Making ART Work Among Brazilian Youth N/A
Completed NCT03842436 - Feasibility and Acceptability of Digital Pills to Monitor PrEP Adherence in MSM With Substance Use Phase 4
Completed NCT03651596 - Leveraging mHealth Messaging to Promote Adherence in Teens With CKD N/A
Completed NCT03081559 - Improving Engagement in HIV Care for High-risk Women N/A
Recruiting NCT05515497 - BMT4me: Post-HSCT Medication Adherence mHealth App N/A
Active, not recruiting NCT04065347 - Quantification of Tenofovir Alafenamide Adherence (QUANTI-TAF)