Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Oral Psoriasis Treatment Adherence and Intervention Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02850900
Recruitment Status : Active, not recruiting
First Posted : August 1, 2016
Last Update Posted : October 27, 2020
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Brief Summary:

Response to psoriasis treatment is variable in large part because of poor adherence treatments. Studies using electronic monitors have assessed adherence to topical and injectable psoriasis treatments and to biologics, yielding critically important insights. Adherence to oral psoriasis treatments is not as well characterized but is also critical, as the therapeutic windows for these treatments are narrower than for other psoriasis treatment options.

The proposed study will assess patients' adherence to oral psoriasis treatment (primarily methotrexate) and will also collect pilot data on an intervention to improve adherence. The primary hypothesis of the investigators study is that adherence to oral psoriasis treatment is poor and that a reporting intervention may improve adherence to oral psoriasis treatment. In the investigator-blinded, 6-month prospective study, patients will be randomized to standard-of-care treatment or standard-of-care supplemented with the weekly online reporting intervention. Adherence will be assessed using electronic monitors. This randomized trial will permit the investigators to determine adherence to oral psoriasis treatment, assess the relationship between adherence and psoriasis outcomes, identify factors that are associated with adherence to oral psoriasis treatment (including physician trust, confidence in the treatment plan, and depression), and obtain preliminary data on the impact of an Internet-reporting measure on patients' adherence to oral psoriasis treatment

.


Condition or disease Intervention/treatment Phase
Psoriasis Behavioral: Internet Survey Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Oral Psoriasis Treatment Adherence and Intervention Study
Study Start Date : April 2016
Actual Primary Completion Date : July 2018
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: Internet Survey
Subject will receive an electronic survey weekly to complete
Behavioral: Internet Survey
Weekly survey will be emailed, subjects should complete them

No Intervention: No Survey
No intervention



Primary Outcome Measures :
  1. Adherence to prescribed oral Methotrexate treatment [ Time Frame: 6 months ]
    Determined by intervention of weekly internet survey compared to no survey

  2. Patterns of Misuse [ Time Frame: 6 months ]
    Self-report of not taking the medication as prescribed;

  3. Psoriasis severity outcomes [ Time Frame: 6 months ]
    The relationship between body surface area, Physician Global Assessment outcomes will be assessed.


Secondary Outcome Measures :
  1. Relationship to Adherence [ Time Frame: 6 months ]
    It will be explored using physician trust scale, a validated tool.

  2. Relationship to Satisfaction [ Time Frame: 6 months ]
    It will be explored using the treatment and satisfaction survey, a validated survey.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Any male or female 12 years or older of age with a diagnosis of psoriasis who is prescribed methotrexate by a dermatologist will be eligible for participation.
  • Greater than 10% 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.

Exclusion Criteria:

  • Individuals younger than 12 years of age.
  • Known allergy or sensitivity to methotrexate.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02850900


Locations
Layout table for location information
United States, North Carolina
Wake Forest University School of Medicine - Department of Dermatology
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest University Health Sciences
Pfizer
Investigators
Layout table for investigator information
Principal Investigator: William H Huang, MD Wake Forest
Publications:

Layout table for additonal information
Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT02850900    
Other Study ID Numbers: IRB00035938
First Posted: August 1, 2016    Key Record Dates
Last Update Posted: October 27, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: will determine at later date

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases