Using an Internet Study to Improve Adherence for Psoriasis Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Wake Forest School of Medicine
Sponsor:
Information provided by (Responsible Party):
Steven R. Feldman, Wake Forest School of Medicine
ClinicalTrials.gov Identifier:
NCT01802580
First received: February 20, 2013
Last updated: May 27, 2014
Last verified: May 2014
  Purpose

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


Condition Intervention
Psoriasis
Behavioral: Internet Survey
Drug: fluocinonide 0.05% ointment

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Using an Internet Study to Improve Adherence for Psoriasis Patients

Resource links provided by NLM:


Further study details as provided by Wake Forest School of Medicine:

Primary Outcome Measures:
  • Measured MEMS Adherence [ Time Frame: 1 month, 3 months, 6 monthhs, 12 months ] [ Designated as safety issue: No ]

    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:
  • MEMS cap relation to internet survey [ Time Frame: 1 month, 3 months, 6 months, 12 months ] [ Designated as safety issue: No ]

    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.


  • Disease Severity with PASI and IGA assessment [ Time Frame: baseline, 1 month, 3 months, 6 months, 12 months ] [ Designated as safety issue: Yes ]

    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.


  • MEMs cap data compared to PASI and IGA Assessment [ Time Frame: 1 month, 3 months, 6 months,12 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 40
Study Start Date: October 2012
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01802580

Contacts
Contact: Susie C Dowd 336-716-3775 sdowd@wakhealth.edu

Locations
United States, North Carolina
Wake Forest School of Medicine - Dermatology Clinic Recruiting
Winston Salem, North Carolina, United States, 27157
Contact: Susie C Dowd    336-716-3775    sdowd@wakhealth.edu   
Contact: Irma M Richardson, MHA    336-716-2903    irichard@wakehealth.edu   
Principal Investigator: Steven R Feldman, MD, PhD         
Sponsors and Collaborators
Wake Forest School of Medicine
Investigators
Principal Investigator: Steven R Feldman, MD, PhD Wake Forest School of Medicine
  More Information

No publications provided

Responsible Party: Steven R. Feldman, Professor, Wake Forest School of Medicine
ClinicalTrials.gov Identifier: NCT01802580     History of Changes
Other Study ID Numbers: IRB00021783
Study First Received: February 20, 2013
Last Updated: May 27, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Fluocinonide
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Allergic Agents

ClinicalTrials.gov processed this record on September 30, 2014