Using an Internet Study to Improve Adherence for Psoriasis Patients

Study Description

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Brief Summary:

To evaluate whether participation in an Internet-based intervention helps improve short-term and long-term psoriasis treatment outcomes, in particular, adherence.

Condition or disease	Intervention/treatment	Phase
Psoriasis	Behavioral: Internet Survey; Drug: fluocinonide 0.05% ointment	Not Applicable

Detailed Description:

An investigator-blinded, prospective study of subjects with mild to moderate psoriasis will be conducted. Forty subjects ages 18 years and older will be enrolled.The Internet-based survey will be piloted to evaluate its effect on adherence to topical psoriasis medication. Subjects randomized in a 1:1 ratio to the Internet-survey group will log their impression of the state of their psoriasis on a weekly basis. Subjects in both the intervention and control groups will receive standard-of-care topical fluocinonide 0.05% ointment to be applied to affected areas on the skin twice daily. Adherence to fluocinonide will be assessed using Medication Event Monitoring System (MEMS®) caps, electronic monitors affixed to the medication containers. Investigators and subjects will be blinded to the adherence data until the final (Month 12) treatment visit.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	40 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Investigator)
Primary Purpose:	Treatment
Official Title:	Using an Internet Study to Improve Adherence for Psoriasis Patients
Study Start Date :	October 2012
Actual Primary Completion Date :	March 2016
Actual Study Completion Date :	April 2016

Arms and Interventions

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Arm	Intervention/treatment
Experimental: Intervention - internet reminder survey; Treatment phase is 12 months. During the intervention, each subject will receive fluocinonide 0.05% ointment, a standard treatment for psoriasis. If their psoriasis could be suitably treated with fluocinonide, then they will be asked to participate in the study. At the initial study visit, fluocinonide will be dispensed in a small jar with a MEMS® electronic monitoring cap attached. Subjects will be asked to apply the medication twice daily. They will be asked to the entire affected area, excluding face and genitals. Subjects will be instructed to apply the smallest amount of study medication sufficient to cover the affected areas. At the end of the treatment phase, subjects will have a feedback session with specific results of adherence behavior revealed. They will receive weekly surveys via internet to complete.	Behavioral: Internet Survey Drug: fluocinonide 0.05% ointment; Other Names: Fluonex; Lonide; Lyderm; Fluocinonide-E; Lidex; Lidex-E; Vanos; Licon; Dermacin; Fluex
Experimental: Standard of care, no internet survey; Standard treatment for psoriasis. If it is felt that their psoriasis could be suitably treated with fluocinonide, then they will be asked to participate in the study. At the initial study visit, fluocinonide will be dispensed to the subjects in a small jar with a MEMS® electronic monitoring cap attached. Subjects will be asked to apply the medication twice daily. All subjects will be assigned to treatment with topical fluocinonide to the entire affected area, excluding face and genitals. Subjects will be instructed to apply the smallest amount of study medication sufficient to cover the affected areas. At the end of the treatment phase, subjects will have a feedback session with specific results of adherence behavior revealed.	Drug: fluocinonide 0.05% ointment; Other Names: Fluonex; Lonide; Lyderm; Fluocinonide-E; Lidex; Lidex-E; Vanos; Licon; Dermacin; Fluex

Outcome Measures

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Primary Outcome Measures :

1. Measured MEMS Adherence [ Time Frame: 1 month, 3 months, 6 monthhs, 12 months ]

   The measured adherence (MEMS®) of the Internet survey group compared to the standard-of-care control group after one month (short-term assessment) and twelve months (long-term assessment) of commencing the study

   The MEMS® cap incorporates a microprocessor into the bottle cap of a standard medication bottle. Each time the bottle is opened for at least 3 seconds, the time and date of the opening are recorded. Subjects will be asked to bring the unused portion of the medication jar to each visit so that the medication can be "weighed and refilled". At each visit the information will be downloaded via the MEMS® communicator onto a computer database.

Secondary Outcome Measures :

1. MEMS cap relation to internet survey [ Time Frame: 1 month, 3 months, 6 months, 12 months ]

   The measured adherence by the MEMS® cap in relation to the patient reported adherence via the Internet survey.

   The MEMS® cap incorporates a microprocessor into the bottle cap of a standard medication bottle. Each time the bottle is opened for at least 3 seconds, the time and date of the opening are recorded. Subjects will be asked to bring the unused portion of the medication jar to each visit so that the medication can be "weighed and refilled". At each visit the information will be downloaded via the MEMS® communicator onto a computer database.

2. Disease Severity with PASI and IGA assessment [ Time Frame: baseline, 1 month, 3 months, 6 months, 12 months ]

   The change (dynamic assessment) from baseline visit to each return visit (or end of treatment) in the Psoriasis Area Severity Index and Investigator's Global Assessment.

   Investigator's Global Assessment (IGA): Similar to assessment performed in clinical practice, based on a 6-point scale from 0 (completely clear) to 5 (very severe). Treatment success is defined as score of 0 or 1 (clear or almost clear).

   Psoriasis Area and Severity Index (PASI): The Psoriasis Area and Severity Index is commonly used in clinical trials as a granular measure of disease severity. It is weighted for area in each of the four body regions and scores erythema, induration and desquamation on an overall scale from 0-72. Treatment success is defined as a 75% reduction in PASI score from baseline value.

3. MEMs cap data compared to PASI and IGA Assessment [ Time Frame: 1 month, 3 months, 6 months,12 months ]
   The measured adherence by the MEMS® cap in relation to the change (dynamic assessment) in the Psoriasis Area Severity Index and Investigator's Global Assessment.

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

• Any male or female 18 years or older of age with a diagnosis of mild to moderate psoriasis by a dermatologist will be eligible for participation.
• Less than 20% of body surface involvement for psoriasis.
• Subject is capable of understanding and willing to provide a signed and dated written voluntary informed consent before any protocol specific procedures are performed.
• The subject is able to complete the study and comply with study instructions, including attending all study visits.
• In general good health with no other skin disease, disease state or physical condition which would impair evaluation of psoriasis or which would increase health risk by study participation

Exclusion Criteria:

• Individuals younger than 18 years of age.
• Known allergy or sensitivity to topical fluocinonide.
• Inability to complete all study-related visits, or inability to complete the Internet survey due to inadequate Internet access.
• Introduction of any other prescription medication, topical or systemic, for psoriasis while participating in the study. Subjects who are on systemic anti-inflammatory treatments for psoriasis must be on a stable dose for at least 3 months prior to enrollment.
• Any skin condition or disease that may require concurrent therapy or may confound evaluations
• Current enrollment in any research study involving an investigational drug

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, North Carolina
Wake Forest School of Medicine - Dermatology Clinic
Winston-Salem, North Carolina, United States, 27157

Sponsors and Collaborators

Wake Forest University

Investigators

Principal Investigator:	Steven R Feldman, MD, PhD	Wake Forest University Health Sciences

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Wake Forest University
ClinicalTrials.gov Identifier:	NCT01802580 History of Changes
Other Study ID Numbers:	IRB00021783
First Posted:	March 1, 2013
Last Update Posted:	November 6, 2017
Last Verified:	November 2017

Studies a U.S. FDA-regulated Drug Product:		No
Studies a U.S. FDA-regulated Device Product:		No

Additional relevant MeSH terms:

Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Fluocinonide; Anti-Inflammatory Agents	Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Anti-Allergic Agents