Using an Internet Study to Improve Adherence for Psoriasis Patients

Psoriasis Clinical Trial

Official title:

Using an Internet Study to Improve Adherence for Psoriasis Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01802580
• Other study ID #: IRB00021783
• Status: Completed
• Phase: Early Phase 1
• Start date: October 2012
• Est. completion date: April 2016

Study information

• Verified date: May 2020
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

An investigator-blinded, prospective study of subjects with mild to moderate psoriasis will be conducted. Forty subjects ages 18 years and older will be enrolled.The Internet-based survey will be piloted to evaluate its effect on adherence to topical psoriasis medication. Subjects randomized in a 1:1 ratio to the Internet-survey group will log their impression of the state of their psoriasis on a weekly basis. Subjects in both the intervention and control groups will receive standard-of-care topical fluocinonide 0.05% ointment to be applied to affected areas on the skin twice daily. Adherence to fluocinonide 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 12) treatment visit.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Psoriasis

Intervention

Behavioral:
• Internet Survey

Drug:
• fluocinonide 0.05% ointment

Locations

Country	Name	City	State
United States	Wake Forest University Health Sciences Department of Dermatology	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University

Country where clinical trial is conducted

United States, 

References & Publications (19)

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. — View Citation

Camisa C. Psoriasis. Oxford: Blackwell Scienti?c Publications, 1994

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. — View Citation

Eysenbach G. The law of attrition. J Med Internet Res. 2005 Mar 31;7(1):e11. — View Citation

Feinstein AR. On white-coat effects and the electronic monitoring of compliance. Arch Intern Med. 1990 Jul;150(7):1377-8. — View Citation

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

Fouéré 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. — View Citation

Laufs U, Böhm M, Kroemer HK, Schüssel 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. Review. German. — View Citation

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. Review. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Witkowski JA. Compliance: the dermatologic patient. Int J Dermatol. 1988 Nov;27(9):608-11. Review. — View Citation

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. — View Citation

Zaghloul SS, Goodfield MJ. Objective assessment of compliance with psoriasis treatment. Arch Dermatol. 2004 Apr;140(4):408-14. — View Citation

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. Review. — View Citation

* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Mean of Days Per Week Medication Was Taken - Internet Survey	The average number of days per week that participants reported taking the medication in the internet survey	up to 12 months
Secondary	Disease Severity With PASI	Psoriasis Area and Severity Index (PASI): The Psoriasis Area and Severity Index is commonly used in clinical trials as a granular measure of disease severity. PASI combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease). It is weighted for area in each of the four body regions and scores erythema, induration and desquamation on an overall scale from 0-72. Treatment success is defined as a 75% reduction in PASI score from baseline value.	baseline and 12 months
Secondary	Disease Severity With IGA Assessment	Investigator's Global Assessment (IGA): Similar to assessment performed in clinical practice, based on a 6-point scale from 0 (completely clear) to 5 (very severe). Treatment success is defined as score of 0 or 1 (clear or almost clear).	baseline and 12 months