Oral Psoriasis Treatment Adherence and Intervention Study

NCT02850900 | Completed

• 1 other identifier: IRB00035938
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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 .

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (3)

• Adherence to prescribed oral Methotrexate treatment

  Determined by intervention of weekly internet survey compared to no survey

  6 months

• Patterns of Misuse

  Self-report of not taking the medication as prescribed;

  6 months

• Psoriasis severity outcomes

  The relationship between body surface area, Physician Global Assessment outcomes will be assessed.

  6 months

Secondary Outcomes (2)

• Relationship to Adherence

  6 months

• Relationship to Satisfaction

  6 months

Study Arms (2)

Internet Survey

EXPERIMENTAL

Subject will receive an electronic survey weekly to complete

Behavioral: Internet Survey

No Survey

NO INTERVENTION

No intervention

Interventions

Internet Survey BEHAVIORAL

Weekly survey will be emailed, subjects should complete them

Internet Survey

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• Pfizer: collaborator

Study Sites (1)

Wake Forest University School of Medicine - Department of Dermatology

Winston-Salem, North Carolina, 27157, United States

Location

Related Publications (12)

• Richards HL, Fortune DG, O'Sullivan TM, Main CJ, Griffiths CE. Patients with psoriasis and their compliance with medication. J Am Acad Dermatol. 1999 Oct;41(4):581-3.

  PMID: 10495380 BACKGROUND

• Carroll CL, Feldman SR, Camacho FT, Balkrishnan R. Better medication adherence results in greater improvement in severity of psoriasis. Br J Dermatol. 2004 Oct;151(4):895-7. doi: 10.1111/j.1365-2133.2004.06174.x.

  PMID: 15491434 BACKGROUND

• Storm A, Andersen SE, Benfeldt E, Serup J. One in 3 prescriptions are never redeemed: primary nonadherence in an outpatient clinic. J Am Acad Dermatol. 2008 Jul;59(1):27-33. doi: 10.1016/j.jaad.2008.03.045. Epub 2008 May 7.

  PMID: 18467003 BACKGROUND

• Balkrishnan R, Dugan E, Camacho FT, Hall MA. Trust and satisfaction with physicians, insurers, and the medical profession. Med Care. 2003 Sep;41(9):1058-64. doi: 10.1097/01.MLR.0000083743.15238.9F.

  PMID: 12972845 BACKGROUND

• Hall MA, Dugan E, Zheng B, Mishra AK. Trust in physicians and medical institutions: what is it, can it be measured, and does it matter? Milbank Q. 2001;79(4):613-39, v. doi: 10.1111/1468-0009.00223.

  PMID: 11789119 BACKGROUND

• Hall MA, Zheng B, Dugan E, Camacho F, Kidd KE, Mishra A, Balkrishnan R. Measuring patients' trust in their primary care providers. Med Care Res Rev. 2002 Sep;59(3):293-318. doi: 10.1177/1077558702059003004.

  PMID: 12205830 BACKGROUND

• Atkinson MJ, Sinha A, Hass SL, Colman SS, Kumar RN, Brod M, Rowland CR. Validation of a general measure of treatment satisfaction, the Treatment Satisfaction Questionnaire for Medication (TSQM), using a national panel study of chronic disease. Health Qual Life Outcomes. 2004 Feb 26;2:12. doi: 10.1186/1477-7525-2-12.

  PMID: 14987333 BACKGROUND

• Murphy J, Coster G. Issues in patient compliance. Drugs. 1997 Dec;54(6):797-800. doi: 10.2165/00003495-199754060-00002.

  PMID: 9421690 BACKGROUND

• Frances C, Cosnes A, Duhaut P, Zahr N, Soutou B, Ingen-Housz-Oro S, Bessis D, Chevrant-Breton J, Cordel N, Lipsker D, Costedoat-Chalumeau N. Low blood concentration of hydroxychloroquine in patients with refractory cutaneous lupus erythematosus: a French multicenter prospective study. Arch Dermatol. 2012 Apr;148(4):479-84. doi: 10.1001/archdermatol.2011.2558.

  PMID: 22508872 BACKGROUND

• Eisen SA, Woodward RS, Miller D, Spitznagel E, Windham CA. The effect of medication compliance on the control of hypertension. J Gen Intern Med. 1987 Sep-Oct;2(5):298-305. doi: 10.1007/BF02596162.

  PMID: 3655955 BACKGROUND

• Paterson DL, Swindells S, Mohr J, Brester M, Vergis EN, Squier C, Wagener MM, Singh N. Adherence to protease inhibitor therapy and outcomes in patients with HIV infection. Ann Intern Med. 2000 Jul 4;133(1):21-30. doi: 10.7326/0003-4819-133-1-200007040-00004.

  PMID: 10877736 BACKGROUND

• Urquhart J. The electronic medication event monitor. Lessons for pharmacotherapy. Clin Pharmacokinet. 1997 May;32(5):345-56. doi: 10.2165/00003088-199732050-00001. No abstract available.

  PMID: 9160169 BACKGROUND

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• William H Huang, MD

  Wake Forest

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2016
• First Posted: August 1, 2016
• Study Start: April 1, 2016
• Primary Completion: July 1, 2018
• Study Completion: September 13, 2021
• Last Updated: December 13, 2023

Record last verified: 2023-09

Locations

US (1)