Using an Internet Study to Improve Adherence for Psoriasis Patients
18 mai 2020 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
40
Phase
- Première phase 1
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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North Carolina
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Winston-Salem, North Carolina, États-Unis, 27157
- Wake Forest University Health Sciences Department of Dermatology
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Tout
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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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Autres noms:
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Expérimental: 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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Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Measured MEMS Adherence- Number of Days With a Correct Number of Doses Taken
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Mean of Days Per Week Medication Was Taken - Internet Survey
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Steven R Feldman, MD, PhD, Wake Forest University Health Sciences
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- 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.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 octobre 2012
Achèvement primaire (Réel)
1 mars 2016
Achèvement de l'étude (Réel)
1 avril 2016
Dates d'inscription aux études
Première soumission
20 février 2013
Première soumission répondant aux critères de contrôle qualité
27 février 2013
Première publication (Estimation)
1 mars 2013
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
4 juin 2020
Dernière mise à jour soumise répondant aux critères de contrôle qualité
18 mai 2020
Dernière vérification
1 mai 2020
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- IRB00021783
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Oui
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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