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Dermatologic DiseaseNCT03658252

Efficacy of Targeted Intervention for Topical Steroid Phobia.

A study testing Targeted education and Online disease specific forum in people with Dermatologic Disease and Phobia, run by National University Health System, Singapore at 1 site in Singapore.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 21 years and older
What is being tested?
Targeted education and Online disease specific forum
Could I receive a placebo?
No, everyone receives an active treatment
How many people
270 participants
Where
1 siteSingapore
Study dates
1 Oct 2018to 4 May 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Singapore1 site

  • National University Hospital

    Singapore

Other trials in Singapore

About this study

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

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.

Read the 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.

Being tested
Targeted education, Online disease specific forum
Keywords
steroid phobia, topical corticosteroids, eczema, psoriasis, adherence, quality of life
Medical subject headings
Skin Diseases, Phobic Disorders, Medication Adherence, Eczema, Psoriasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Targeted educationBehavioural

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

  • Online disease specific forumBehavioural

    An invitation to join an online moderated disease specific social forum

Study groups in NCT03658252
Study groupRoleWhat they receive
InterventionExperimentalParticipants 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.
Receives: Behavioral: Targeted education; Behavioral: Online disease specific forum
ControlNo interventionPatients in the control arm will receive only standard medical care and counseling by their dermatologist as clinically indicated.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 3 months

Secondary outcomes (5)

  1. 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.

    Measured: 1 month

  2. 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.

    Measured: 1 month

  3. 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.

    Measured: 3 month

  4. 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.

    Measured: 1 month

  5. 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.

    Measured: 3 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Sep 2018
  2. Study start1 Oct 2018
  3. Primary completion31 Dec 2018
  4. Study completion4 May 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
270 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03658252
Sponsor's protocol ID
2018/00481
Other IDs
2018
Status last verified
Feb 2020
First submitted
31 Aug 2018
Last updated
26 Feb 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 18946201

  • 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.

    PubMed 20465705

  • 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.

    PubMed 24146878

Questions about this trial

What is this clinical trial studying?

A study testing Targeted education and Online disease specific forum in people with Dermatologic Disease and Phobia, run by National University Health System, Singapore at 1 site in Singapore.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in TOPICOP© score at 3 months (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03658252, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2020.

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