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To evaluate whether participation in an Internet-based intervention helps improve short-term and long-term psoriasis treatment outcomes, in particular, adherence.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Internet Survey | Behavioral |
| ||
| fluocinonide 0.05% ointment |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Disease Severity With PASI |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven R Feldman, MD, PhD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest University Health Sciences Department of Dermatology | Winston-Salem | North Carolina | 27157 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Camisa C. Psoriasis. Oxford: Blackwell Scientific Publications, 1994 | ||
| 9703127 | 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. | |
| 3068168 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention - Internet Reminder Survey | 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. Internet Survey fluocinonide 0.05% ointment |
| FG001 | Standard of Care, no Internet Survey | 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. fluocinonide 0.05% ointment |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Description of participants that completed study
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Intervention - Internet Reminder Survey | 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. Internet Survey fluocinonide 0.05% ointment |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Mean | Full Range | Days | up to 12 months |
|
up to 12 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention - Internet Reminder Survey | 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. Internet Survey fluocinonide 0.05% ointment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fungal Infection | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Fungal infection |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Steve Feldman, Professor of Dermatology, Public Health Scienes, and Pathology | Wake Forest University Health Sciences | 336-716-7740 | sfeldman@wakehealth.edu |
Not provided
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D005447 | Fluocinonide |
| D009824 | Ointments |
| ID | Term |
|---|---|
| D005446 | Fluocinolone Acetonide |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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| Drug |
|
|
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 |
| 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 |
| Background |
| Witkowski JA. Compliance: the dermatologic patient. Int J Dermatol. 1988 Nov;27(9):608-11. doi: 10.1111/j.1365-4362.1988.tb02416.x. No abstract available. |
| 10495380 | 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. |
| 16274404 | 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. |
| 10894958 | 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. |
| 15280839 | 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. |
| 22006146 | 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. |
| 15096368 | 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. |
| 24684738 | 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. |
| 21809255 | 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. |
| 23999953 | 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. |
| 18467003 | 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. |
| 26079456 | 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. |
| 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. |
| 22096523 | 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. |
| 2369237 | 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. |
| 15829473 | Background | Eysenbach G. The law of attrition. J Med Internet Res. 2005 Mar 31;7(1):e11. doi: 10.2196/jmir.7.1.e11. |
| Withdrawal by Subject |
|
| Other |
|
| Lack of Efficacy |
|
| BG001 | Standard of Care, no Internet Survey | 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. fluocinonide 0.05% ointment |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | Standard of Care, no Internet Survey | 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. fluocinonide 0.05% ointment |
|
|
| 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 | Includes all participants randomized to this arm. Because the other arm has no internet reminder, there will only be one arm reported for this measure. | Posted | Mean | Full Range | days per week | 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. | Data not collected on all participants | Posted | Mean | Standard Deviation | score on a scale | 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). | data not collected in all participants at month 12 | Posted | Mean | Standard Deviation | score on a scale | baseline and 12 months |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 1 |
| 20 |
| EG001 | Standard of Care, no Internet Survey | 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. fluocinonide 0.05% ointment | 0 | 20 | 0 | 20 | 1 | 20 |
|
| Burning Sensation | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Burning sensation where drug is applied |
|
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| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
| month 12 |
|
|
| month 12 |
|
|