Using an Internet Study to Improve Adherence for Psoriasis Patients

NCT01802580 | Completed Early Phase 1 Results FDA Drug

• 1 other identifier: IRB00021783
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (1)

• Measured MEMS Adherence- Number of Days With a Correct Number of Doses Taken

  Number of days patients adhered to the treatment is reported. All subjects receive the MEMs caps on their medication and it is reported by the "number" of days that the "dosage" was taken correctly, either with or without internet reminder survey intervention. number of days with a correct number of doses taken

  up to 12 months

Secondary Outcomes (3)

• Mean of Days Per Week Medication Was Taken - Internet Survey

  up to 12 months

• Disease Severity With PASI

  baseline and 12 months

• Disease Severity With IGA Assessment

  baseline and 12 months

Study Arms (2)

Intervention - internet reminder survey

EXPERIMENTAL

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

Standard of care, no internet survey

EXPERIMENTAL

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

Interventions

Internet Survey BEHAVIORAL

Intervention - internet reminder survey

fluocinonide 0.05% ointment DRUG

Also known as: Fluonex, Lonide, Lyderm, Fluocinonide-E, Lidex, Lidex-E, Vanos, Licon, Dermacin, Fluex

Intervention - internet reminder survey; Standard of care, no internet survey

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University: lead

Study Sites (1)

Wake Forest University Health Sciences Department of Dermatology

Winston-Salem, North Carolina, 27157, United States

Location

Related Publications (19)

• Camisa C. Psoriasis. Oxford: Blackwell Scientific Publications, 1994

  BACKGROUND

• Piacquadio D, Kligman A. The critical role of the vehicle to therapeutic efficacy and patient compliance. J Am Acad Dermatol. 1998 Aug;39(2 Pt 3):S67-73. doi: 10.1016/s0190-9622(98)70448-7. No abstract available.

  PMID: 9703127 BACKGROUND

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  PMID: 3068168 BACKGROUND

• 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

• Fouere S, Adjadj L, Pawin H. How patients experience psoriasis: results from a European survey. J Eur Acad Dermatol Venereol. 2005 Nov;19 Suppl 3:2-6. doi: 10.1111/j.1468-3083.2005.01329.x.

  PMID: 16274404 BACKGROUND

• van de Kerkhof PC, de Hoop D, de Korte J, Cobelens SA, Kuipers MV. Patient compliance and disease management in the treatment of psoriasis in the Netherlands. Dermatology. 2000;200(4):292-8. doi: 10.1159/000018390.

  PMID: 10894958 BACKGROUND

• Carroll CL, Feldman SR, Camacho FT, Manuel JC, Balkrishnan R. Adherence to topical therapy decreases during the course of an 8-week psoriasis clinical trial: commonly used methods of measuring adherence to topical therapy overestimate actual use. J Am Acad Dermatol. 2004 Aug;51(2):212-6. doi: 10.1016/j.jaad.2004.01.052.

  PMID: 15280839 BACKGROUND

• Yentzer BA, Wood AA, Sagransky MJ, O'Neill JL, Clark AR, Williams LL, Feldman SR. An Internet-based survey and improvement of acne treatment outcomes. Arch Dermatol. 2011 Oct;147(10):1223-4. doi: 10.1001/archdermatol.2011.277. No abstract available.

  PMID: 22006146 BACKGROUND

• Zaghloul SS, Goodfield MJ. Objective assessment of compliance with psoriasis treatment. Arch Dermatol. 2004 Apr;140(4):408-14. doi: 10.1001/archderm.140.4.408.

  PMID: 15096368 BACKGROUND

• Zschocke I, Mrowietz U, Karakasili E, Reich K. Non-adherence and measures to improve adherence in the topical treatment of psoriasis. J Eur Acad Dermatol Venereol. 2014 May;28 Suppl 2:4-9. doi: 10.1111/jdv.12445.

  PMID: 24684738 BACKGROUND

• Laufs U, Bohm M, Kroemer HK, Schussel K, Griese N, Schulz M. [Strategies to improve medication adherence]. Dtsch Med Wochenschr. 2011 Aug;136(31-32):1616-21. doi: 10.1055/s-0031-1281566. Epub 2011 Aug 1. German.

  PMID: 21809255 BACKGROUND

• McGrady ME, Hommel KA. Medication adherence and health care utilization in pediatric chronic illness: a systematic review. Pediatrics. 2013 Oct;132(4):730-40. doi: 10.1542/peds.2013-1451. Epub 2013 Sep 2.

  PMID: 23999953 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

• Aslam I, Feldman SR. Practical Strategies to Improve Patient Adherence to Treatment Regimens. South Med J. 2015 Jun;108(6):325-31. doi: 10.14423/SMJ.0000000000000294. No abstract available.

  PMID: 26079456 BACKGROUND

• Feldman SR. Practical Ways to Improve Patients' Treatment Outcomes. Winston-Salem, NC:Medical Quality Enhancement Corporation, 2008.

  BACKGROUND

• Miller WR, Rollnick S. Motivational Interviewing: Helping People Change, 3rd edn. New York: Guilford Press, 2013.

  BACKGROUND

• van der Meer V, van den Hout WB, Bakker MJ, Rabe KF, Sterk PJ, Assendelft WJ, Kievit J, Sont JK; SMASHING (Self-Management in Asthma Supported by Hospitals, ICT, Nurses and General Practitioners) Study Group. Cost-effectiveness of Internet-based self-management compared with usual care in asthma. PLoS One. 2011;6(11):e27108. doi: 10.1371/journal.pone.0027108. Epub 2011 Nov 11.

  PMID: 22096523 BACKGROUND

• Feinstein AR. On white-coat effects and the electronic monitoring of compliance. Arch Intern Med. 1990 Jul;150(7):1377-8. No abstract available.

  PMID: 2369237 BACKGROUND

• Eysenbach G. The law of attrition. J Med Internet Res. 2005 Mar 31;7(1):e11. doi: 10.2196/jmir.7.1.e11.

  PMID: 15829473 BACKGROUND

MeSH Terms

Conditions

Psoriasis

Interventions

Fluocinonide; Ointments

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Fluocinolone Acetonide; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Dosage Forms; Pharmaceutical Preparations

Limitations and Caveats

A limitation is we did not have continuous measure of disease severity and could not fully assess how much any changes in disease severity affected subjects' use of medication.

Results Point of Contact

• Title: Dr. Steve Feldman, Professor of Dermatology, Public Health Scienes, and Pathology
• Organization: Wake Forest University Health Sciences

sfeldman@wakehealth.edu

336-716-7740

Study Officials

• Steven R Feldman, MD, PhD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2013
• First Posted: March 1, 2013
• Study Start: October 1, 2012
• Primary Completion: March 1, 2016
• Study Completion: April 1, 2016
• Last Updated: June 4, 2020
• Results First Posted: November 12, 2019

Record last verified: 2020-05

Locations

US (1)