Oral Psoriasis Treatment Adherence and Intervention Study
NCT ID: NCT02850900
Last Updated: 2023-12-13
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
29 participants
Study Classification
INTERVENTIONAL
Study Start Date
2016-04-30
Study Completion Date
2021-09-13
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
.
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
.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Psoriasis is a common, chronic inflammatory disease that has a major impact on patients' quality of life. Patients' response to treatment is variable. Poor adherence to topical, oral and biologic psoriasis treatments is common and may account for poor responses.1, 2 Many psoriasis patients do not even fill their prescriptions.3 Electronic monitoring of adherence provides the most detailed and accurate way to assess adherence. While studies using electronic monitors have assessed adherence to topical psoriasis treatments and to biologics, adherence to oral psoriasis treatments is not as well characterized. Understanding adherence to oral psoriasis treatments is critical, as the therapeutic windows for these treatments are narrower than for other psoriasis treatment options, making adherence to recommended dosing all the more critical.
Developing methods to improve psoriasis patients' adherence has the potential to provide an immediate, practical means to improve patients' treatment outcomes. Return visits improve patients' use of medication \& treatment outcomes but are not practical and add additional costs to the patient and medical system. Having patients report on their treatment experience without an office visit offers promise for improving adherence but has not been tested in a psoriasis population.
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.
The Specific Aims of this study are:
1. To determine adherence to oral psoriasis treatments (methotrexate) with electronic monitors.
2. To assess the relationship between adherence and psoriasis outcomes (measured by body surface area \[BSA\], Physician Global Assessment \[PGA\] and \[BSA\]x\[PGA\]).
3. To identify factors that are associated with adherence to oral psoriasis treatment, including physician trust, confidence in the treatment plan, and depression which will be measured with the Wake Forest University Physician Trust Scale (WFUPTS),4-6 the Treatment Satisfaction Questionnaire for Medication (TSQM),7 and the Hamilton Depression Rating Scale (HAM-D).
4. To test obtain preliminary data on the impact of an Internet-reporting measure on patients' adherence to oral psoriasis treatment.
The investigators propose an investigator-blinded, 6-month prospective study of 40 patients aged 12 and older who have been prescribed oral psoriasis treatment. Adherence 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 6) treatment visit.
This study is of high significance, providing critically important information on how patients use oral psoriasis treatments, as well as a foundation to develop and implement intervention trials to improve adherence and outcomes in patients treated with oral psoriasis treatments. Innovations in this study include seeking to change the paradigm of the investigators understanding of the role of adherence in oral psoriasis treatment, including effects on treatment failures and side effects, developing a new understanding of the roles of physician and medication trust in adherence, and potentially changing the timing and methods of clinical assessments in psoriasis (and other) patients in light of the effects of the timing and methods of clinical assessments on treatment adherence and outcomes. The use of objective electronic adherence monitors and well-validated assessment tools adds strength to the approach of this study; another strength of the approach is careful attention to research ethics of adherence monitoring. The environment of this study is particularly strong, with facilities for and extensive experience in all aspects of adherence monitoring research.
The overall goal of this study is to better understand and improve adherence behaviors in patients with psoriasis, a common, chronic, relapsing, inflammatory disease. Psoriasis reduces patients' quality of life, yet patients with psoriasis, as with other chronic diseases, frequently misuse medicine, impairing effectiveness of prescribed therapies (when underused) and increasing the risks of treatment (when overused or mistimed).8 Poor adherence to treatment can be misconstrued as poor response, which can lead to unnecessary treatment escalation resulting in exposing patients to more toxic or costly medications.9 In many cases, non-adherence, rather than non-response, is the underlying precursor of treatment failure.10, 11
Adherence issues with oral psoriasis treatment are largely unexplored and are of critical importance. Oral methotrexate is widely used (encouraged by payors), yet it is risky, with a more narrow therapeutic window than biologics. Other oral agents approved for psoriasis include cyclosporine (with a risk of renal disease) and apremilast (which is associated with gastrointestinal tolerability issues). While large database studies find that oral psoriasis treatment is underused, the variation in use of oral psoriasis treatments among patients is critically important and has not been defined.
Traditional methods for measuring medical adherence tend to be unreliable. Assessment methods such as patient interviews, questionnaires, surveys, and diaries deliver inconsistent data that depend upon the patient's willingness to accurately record medication use and ability to remember what they did. Electronic monitoring devices offer an effective means for objective adherence monitoring. Medication Event Monitoring System caps (MEMS®, AARDEX Corp., Fremont, CA) include microprocessors in the bottle cap of a standard medication bottle that record each time and date the bottle is opened and the interval since the last bottle opening.12
The availability of accurate electronic adherence measurement provides a foundation to study novel ways to improve adherence. In several studies of psoriasis and other inflammatory skin diseases, a clear pattern of improved adherence around the time of office visits is evident. The tendency for patients to be more adherent around the time of office visits may be a form of a more general tendency to be adherent when interacting with the healthcare system to assess their treatment outcomes, a form of "white coat compliance" or Hawthorne effect. A pilot study of adolescents with acne vulgaris tested whether adherence to topical benzoyl peroxide could be improved by weekly online-reporting of their treatment experience.
Developing methods to improve psoriasis patients' adherence has the potential to provide an immediate, practical means to improve patients' treatment outcomes. Return visits improve patients' use of medication \& treatment outcomes but are not practical and add additional costs to the patient and medical system. Having patients report on their treatment experience without an office visit offers promise for improving adherence but has not been tested in a psoriasis population.
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.
The Specific Aims of this study are:
1. To determine adherence to oral psoriasis treatments (methotrexate) with electronic monitors.
2. To assess the relationship between adherence and psoriasis outcomes (measured by body surface area \[BSA\], Physician Global Assessment \[PGA\] and \[BSA\]x\[PGA\]).
3. To identify factors that are associated with adherence to oral psoriasis treatment, including physician trust, confidence in the treatment plan, and depression which will be measured with the Wake Forest University Physician Trust Scale (WFUPTS),4-6 the Treatment Satisfaction Questionnaire for Medication (TSQM),7 and the Hamilton Depression Rating Scale (HAM-D).
4. To test obtain preliminary data on the impact of an Internet-reporting measure on patients' adherence to oral psoriasis treatment.
The investigators propose an investigator-blinded, 6-month prospective study of 40 patients aged 12 and older who have been prescribed oral psoriasis treatment. Adherence 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 6) treatment visit.
This study is of high significance, providing critically important information on how patients use oral psoriasis treatments, as well as a foundation to develop and implement intervention trials to improve adherence and outcomes in patients treated with oral psoriasis treatments. Innovations in this study include seeking to change the paradigm of the investigators understanding of the role of adherence in oral psoriasis treatment, including effects on treatment failures and side effects, developing a new understanding of the roles of physician and medication trust in adherence, and potentially changing the timing and methods of clinical assessments in psoriasis (and other) patients in light of the effects of the timing and methods of clinical assessments on treatment adherence and outcomes. The use of objective electronic adherence monitors and well-validated assessment tools adds strength to the approach of this study; another strength of the approach is careful attention to research ethics of adherence monitoring. The environment of this study is particularly strong, with facilities for and extensive experience in all aspects of adherence monitoring research.
The overall goal of this study is to better understand and improve adherence behaviors in patients with psoriasis, a common, chronic, relapsing, inflammatory disease. Psoriasis reduces patients' quality of life, yet patients with psoriasis, as with other chronic diseases, frequently misuse medicine, impairing effectiveness of prescribed therapies (when underused) and increasing the risks of treatment (when overused or mistimed).8 Poor adherence to treatment can be misconstrued as poor response, which can lead to unnecessary treatment escalation resulting in exposing patients to more toxic or costly medications.9 In many cases, non-adherence, rather than non-response, is the underlying precursor of treatment failure.10, 11
Adherence issues with oral psoriasis treatment are largely unexplored and are of critical importance. Oral methotrexate is widely used (encouraged by payors), yet it is risky, with a more narrow therapeutic window than biologics. Other oral agents approved for psoriasis include cyclosporine (with a risk of renal disease) and apremilast (which is associated with gastrointestinal tolerability issues). While large database studies find that oral psoriasis treatment is underused, the variation in use of oral psoriasis treatments among patients is critically important and has not been defined.
Traditional methods for measuring medical adherence tend to be unreliable. Assessment methods such as patient interviews, questionnaires, surveys, and diaries deliver inconsistent data that depend upon the patient's willingness to accurately record medication use and ability to remember what they did. Electronic monitoring devices offer an effective means for objective adherence monitoring. Medication Event Monitoring System caps (MEMS®, AARDEX Corp., Fremont, CA) include microprocessors in the bottle cap of a standard medication bottle that record each time and date the bottle is opened and the interval since the last bottle opening.12
The availability of accurate electronic adherence measurement provides a foundation to study novel ways to improve adherence. In several studies of psoriasis and other inflammatory skin diseases, a clear pattern of improved adherence around the time of office visits is evident. The tendency for patients to be more adherent around the time of office visits may be a form of a more general tendency to be adherent when interacting with the healthcare system to assess their treatment outcomes, a form of "white coat compliance" or Hawthorne effect. A pilot study of adolescents with acne vulgaris tested whether adherence to topical benzoyl peroxide could be improved by weekly online-reporting of their treatment experience.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Psoriasis
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
SINGLE
Investigators
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Internet Survey
Subject will receive an electronic survey weekly to complete
Group Type
EXPERIMENTAL
Internet Survey
Intervention Type
BEHAVIORAL
Weekly survey will be emailed, subjects should complete them
No Survey
No intervention
Group Type
NO_INTERVENTION
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Internet Survey
Weekly survey will be emailed, subjects should complete them
Intervention Type
BEHAVIORAL
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
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.
* 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.
* 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.
Minimum Eligible Age
12 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Pfizer
INDUSTRY
Sponsor Role
collaborator
Wake Forest University Health Sciences
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Responsibility Role
SPONSOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
William H Huang, MD
Role: PRINCIPAL_INVESTIGATOR
Wake Forest
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Wake Forest University School of Medicine - Department of Dermatology
Winston-Salem, North Carolina, United States
Site Status
Countries
Review the countries where the study has at least one active or historical site.
United States
References
Explore related publications, articles, or registry entries linked to this study.
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
BACKGROUND
Murphy J, Coster G. Issues in patient compliance. Drugs. 1997 Dec;54(6):797-800. doi: 10.2165/00003495-199754060-00002.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
BACKGROUND
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Informed Consent Form
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IRB00035938
Identifier Type: -
Identifier Source: org_study_id