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Efficacy of Targeted Intervention for Topical Steroid Phobia.

Primary Purpose

Dermatologic Disease, Phobia, Adherence, Medication

Status
Completed
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Targeted education
Online disease specific forum
Sponsored by
National University Health System, Singapore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Dermatologic Disease focused on measuring steroid phobia, topical corticosteroids, eczema, psoriasis, adherence, quality of life

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

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.

Patients in the control arm will receive only standard medical care and counseling by their dermatologist as clinically indicated.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.

Full Information

First Posted
August 31, 2018
Last Updated
February 25, 2020
Sponsor
National University Health System, Singapore
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1. Study Identification

Unique Protocol Identification Number
NCT03658252
Brief Title
Efficacy of Targeted Intervention for Topical Steroid Phobia.
Official Title
A Randomised Controlled Trial Assessing the Efficacy of Targeted Intervention for Topical Steroid Phobia.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
May 4, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National University Health System, Singapore

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dermatologic Disease, Phobia, Adherence, Medication
Keywords
steroid phobia, topical corticosteroids, eczema, psoriasis, adherence, quality of life

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
270 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Patients in the control arm will receive only standard medical care and counseling by their dermatologist as clinically indicated.
Intervention Type
Behavioral
Intervention Name(s)
Targeted education
Intervention Description
Educational video developed by the hospital, addressing common misconceptions of topical steroids. A patient information leaflet on topical steroids
Intervention Type
Behavioral
Intervention Name(s)
Online disease specific forum
Intervention Description
An invitation to join an online moderated disease specific social forum
Primary Outcome Measure Information:
Title
Change in TOPICOP© score at 3 months
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Change in TOPICOP© score at 1 month
Description
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.
Time Frame
1 month
Title
Change in ECOB (Elaboration d'un outil d'evaluation de l'observance des traitements médicamenteux) score at 1 month
Description
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.
Time Frame
1 month
Title
Change in ECOB (Elaboration d'un outil d'evaluation de l'observance des traitements médicamenteux) score at 3 month
Description
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.
Time Frame
3 month
Title
Change in Dermatology Life Quality Index score at 1 month
Description
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.
Time Frame
1 month
Title
Change in Dermatology Life Quality Index score at 3 month
Description
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.
Time Frame
3 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ellie Choi, MBBS, MRCP, MMed (IM)
Organizational Affiliation
National University Healthcare System
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Chris Tan, MBBS, FAMS
Organizational Affiliation
National University Healthcare System
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Nisha Chandran, MBBS, MRCP, MMed (IM)
Organizational Affiliation
National University Healthcare System
Official's Role
Study Director
Facility Information:
Facility Name
National University Hospital
City
Singapore
Country
Singapore

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
18946201
Citation
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.
Results Reference
background
PubMed Identifier
20465705
Citation
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.
Results Reference
background
PubMed Identifier
24146878
Citation
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.
Results Reference
background

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Efficacy of Targeted Intervention for Topical Steroid Phobia.

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