- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01802580
Using an Internet Study to Improve Adherence for Psoriasis Patients
18 de mayo de 2020 actualizado por: Wake Forest University
To evaluate whether participation in an Internet-based intervention helps improve short-term and long-term psoriasis treatment outcomes, in particular, adherence.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Actual)
40
Fase
- Fase temprana 1
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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North Carolina
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Winston-Salem, North Carolina, Estados Unidos, 27157
- Wake Forest University Health Sciences Department of Dermatology
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: 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.
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Otros nombres:
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Experimental: 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.
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Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Measured MEMS Adherence- Number of Days With a Correct Number of Doses Taken
Periodo de tiempo: up to 12 months
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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
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Mean of Days Per Week Medication Was Taken - Internet Survey
Periodo de tiempo: up to 12 months
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The average number of days per week that participants reported taking the medication in the internet survey
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up to 12 months
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Disease Severity With PASI
Periodo de tiempo: baseline and 12 months
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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.
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baseline and 12 months
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Disease Severity With IGA Assessment
Periodo de tiempo: baseline and 12 months
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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).
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baseline and 12 months
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Steven R Feldman, MD, PhD, Wake Forest University Health Sciences
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Eysenbach G. The law of attrition. J Med Internet Res. 2005 Mar 31;7(1):e11. doi: 10.2196/jmir.7.1.e11.
- 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.
- 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.
- 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.
- 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.
- Camisa C. Psoriasis. Oxford: Blackwell Scientific Publications, 1994
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Feldman SR. Practical Ways to Improve Patients' Treatment Outcomes. Winston-Salem, NC:Medical Quality Enhancement Corporation, 2008.
- Miller WR, Rollnick S. Motivational Interviewing: Helping People Change, 3rd edn. New York: Guilford Press, 2013.
- 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.
- Feinstein AR. On white-coat effects and the electronic monitoring of compliance. Arch Intern Med. 1990 Jul;150(7):1377-8. No abstract available.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de octubre de 2012
Finalización primaria (Actual)
1 de marzo de 2016
Finalización del estudio (Actual)
1 de abril de 2016
Fechas de registro del estudio
Enviado por primera vez
20 de febrero de 2013
Primero enviado que cumplió con los criterios de control de calidad
27 de febrero de 2013
Publicado por primera vez (Estimar)
1 de marzo de 2013
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
4 de junio de 2020
Última actualización enviada que cumplió con los criterios de control de calidad
18 de mayo de 2020
Última verificación
1 de mayo de 2020
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- IRB00021783
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Sí
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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Ensayos clínicos sobre Internet Survey
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