Efficacy of Targeted Intervention for Topical Steroid Phobia.

NCT03658252 | Completed

• 1 other identifier: 2018/00481
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

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.

Conditions

Dermatologic Disease; Phobia; Adherence, Medication

Keywords

steroid phobia; topical corticosteroids; eczema; psoriasis; adherence; quality of life

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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 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

Study Arms (2)

Intervention

EXPERIMENTAL

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.

Behavioral: Targeted education; Behavioral: Online disease specific forum

Control

NO INTERVENTION

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

Interventions

Targeted education BEHAVIORAL

Educational video developed by the hospital, addressing common misconceptions of topical steroids. A patient information leaflet on topical steroids

Intervention

Online disease specific forum BEHAVIORAL

An invitation to join an online moderated disease specific social forum

Intervention

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• National University Health System, Singapore: lead

Study Sites (1)

National University Hospital

Singapore, Singapore

Location

Related Publications (3)

• 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.

  PMID: 18946201 BACKGROUND

• 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.

  PMID: 20465705 BACKGROUND

• 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.

  PMID: 24146878 BACKGROUND

MeSH Terms

Conditions

Skin Diseases; Phobic Disorders; Medication Adherence; Eczema; Psoriasis

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases; Anxiety Disorders; Mental Disorders; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Dermatitis; Skin Diseases, Eczematous; Skin Diseases, Papulosquamous

Study Officials

• Ellie Choi, MBBS, MRCP, MMed (IM)

  National University Healthcare System

  PRINCIPAL INVESTIGATOR

• Chris Tan, MBBS, FAMS

  National University Healthcare System

  STUDY DIRECTOR

• Nisha Chandran, MBBS, MRCP, MMed (IM)

  National University Healthcare System

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Resident, Division of Dermatology, Department of Medicine, Principal Investigator

Study Record Dates

• First Submitted: August 31, 2018
• First Posted: September 5, 2018
• Study Start: October 1, 2018
• Primary Completion: December 31, 2018
• Study Completion: May 4, 2019
• Last Updated: February 26, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)