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
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||29 participants|
|Intervention Model:||Parallel Assignment|
|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|
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
- Adherence to prescribed oral Methotrexate treatment [ Time Frame: 6 months ]Determined by intervention of weekly internet survey compared to no survey
- Patterns of Misuse [ Time Frame: 6 months ]Self-report of not taking the medication as prescribed;
- Psoriasis severity outcomes [ Time Frame: 6 months ]The relationship between body surface area, Physician Global Assessment outcomes will be assessed.
- Relationship to Adherence [ Time Frame: 6 months ]It will be explored using physician trust scale, a validated tool.
- Relationship to Satisfaction [ Time Frame: 6 months ]It will be explored using the treatment and satisfaction survey, a validated survey.
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
|United States, North Carolina|
|Wake Forest University School of Medicine - Department of Dermatology|
|Winston-Salem, North Carolina, United States, 27157|
|Principal Investigator:||William H Huang, MD||Wake Forest|