Effects of structured patient education in adults with atopic dermatitis: Multicenter randomized controlled trial - 06/09/17

Doi : 10.1016/j.jaci.2017.01.029

Annice Heratizadeh, MD ^a,^⁎ , Thomas Werfel, MD ^a, Andreas Wollenberg, MD ^b, Susanne Abraham, MD ^c, Sibylle Plank-Habibi ^d, Christina Schnopp, MD ^e, Michael Sticherling, MD ^f, Christian Apfelbacher, PhD ^g,^h, Tilo Biedermann, MD ^e,ⁱ, Kristine Breuer, MD ^j, Isabel Fell, MD ^k, Regina Fölster-Holst, MD ^l, Guido Heine, MD ^m, Jennifer Grimm ⁿ, Lars Hennighausen, PhD ^o, Claudia Kugler ^e, Imke Reese, PhD ^p, Johannes Ring, MD ^e,^q, Knut Schäkel, MD ^r, Jochen Schmitt, MD, MPH ^s, Kurt Seikowski, PhD ^t, Esther von Stebut, MD ^u, Nicola Wagner, MD ^v, Anja Waßmann-Otto, PhD ^a, Ute Wienke-Graul, MD ^d, Elke Weisshaar, MD ^g, Margitta Worm, MD ^m, Uwe Gieler, MD ^w, Joerg Kupfer, PhD ^x,^{^{∗
Further members of the Arbeitsgemeinschaft Neurodermitisschulung für Erwachsene (ARNE) Study Group who substantially contributed to the study: Katrin Brauner,^f Sabine Dölle, PhD,^m Laura Ehmann, MD,^b Ute Hagmaier,^g Susanne Eberlein,^d Julia Kroth, MD,^b Katja Lämmerhirt,^c Rosemarie Landleiter,^f Ute Lorenz,^d Anja Lüdemann,^c Uwe Matterne, PhD,^g Heidrun Mitzel-Rink, MD,^u Margarete Niebuhr, MD,^a Tessa Rehberg,^c Sandra Vogel,^b and Katja Wichmann, MD.^a}}
Arbeitsgemeinschaft Neurodermitisschulung für Erwachsene (ARNE) Study Group
Katrin Brauner ^f, Sabine Dölle, PhD ^m, Laura Ehmann, MD ^b, Ute Hagmaier ^g, Susanne Eberlein ^d, Julia Kroth, MD ^b, Katja Lämmerhirt ^c, Rosemarie Landleiter ^f, Ute Lorenz ^d, Anja Lüdemann ^c, Uwe Matterne, PhD ^g, Heidrun Mitzel-Rink, MD ^u, Margarete Niebuhr, MD ^a, Tessa Rehberg ^c, Sandra Vogel ^b, Katja Wichmann, MD ^a
^a Division of Immunodermatology and Allergy Research, Department of Dermatology and Allergy, Hannover Medical School, Hannover, Germany
^b Department of Dermatology and Allergy, Ludwig-Maximilian-Universität Munich, Munich, Germany
^c Department of Dermatology, Medical Faculty Carl-Gustav-Carus, Technical University of Dresden, Dresden, Germany
^d Department of Dermatology and Allergology, Vital Klinik GmbH & Co. KG, Alzenau, Germany
^f Department of Dermatology, Universitätsklinikum Erlangen, Erlangen, Germany
^g Department of Clinical Social Medicine, University Hospital Heidelberg, Heidelberg, Germany
^m Department of Dermatology and Allergy, Campus Mitte, Charité Universitätsmedizin, Berlin, Germany
^u Department of Dermatology, University Medical Center, Johannes Gutenberg-University, Mainz, Germany

^a Division of Immunodermatology and Allergy Research, Department of Dermatology and Allergy, Hannover Medical School, Hannover, Germany
^b Department of Dermatology and Allergy, Ludwig-Maximilian-Universität Munich, Munich, Germany
^c Department of Dermatology, Medical Faculty Carl-Gustav-Carus, Technical University of Dresden, Dresden, Germany
^d Department of Dermatology and Allergology, Vital Klinik GmbH & Co. KG, Alzenau, Germany
^e Department of Dermatology and Allergology Biederstein, Technical University Munich, Munich, Germany
^f Department of Dermatology, Universitätsklinikum Erlangen, Erlangen, Germany
^g Department of Clinical Social Medicine, University Hospital Heidelberg, Heidelberg, Germany
^h Medical Sociology, Institute of Epidemiology and Preventive Medicine, University of Regensburg, Regensburg, Germany
ⁱ Department of Dermatology, Eberhard Karls University, Tübingen, Germany
^j Department of Allergology and Occupational Dermatology, Dermatologikum Hamburg, Hamburg, Germany
^k Dermatology Centre of Rehabilitation and Prevention GmbH Bad Soden, Bad Soden, Germany
^l Department of Dermatology, Universitätsklinikum Schleswig-Holstein, Campus Kiel Dermatologie, Venerologie und Allergologie, Kiel, Germany
^m Department of Dermatology and Allergy, Campus Mitte, Charité Universitätsmedizin, Berlin, Germany
ⁿ Dermatologisches Zentrum Buxtehude, Buxtehude, Germany
^o Psychological Practice, Academy of Neurodermatitis Hessen, Hessen, Germany
^p Nutrition Counselling Allergology, Munich, Germany
^q Christine Kuehne Center for Allergy Research and Education (CK-CARE), Davos, Switzerland
^r Department of Dermatology, University Hospital Heidelberg, Heidelberg, Germany
^s Center for Evidence-based Healthcare, Medizinische Fakultät Carl Gustav Carus, TU Dresden, Dresden, Germany
^t Department of Psychosomatic Medicine, University Leipzig, Leipzig, Germany
^u Department of Dermatology, University Medical Center, Johannes Gutenberg-University, Mainz, Germany
^v Klinikum Darmstadt Bereich Eberstadt Hautklinik, Darmstadt, Germany
^w Department of Dermatology and Allergology, Justus-Liebig-University Giessen, Giessen, Germany
^x Institute of Medical Psychology, Justus-Liebig-University Giessen, Giessen, Germany

^∗Corresponding author: Annice Heratizadeh, MD, Division of Immunodermatology and Allergy Research, Department of Dermatology and Allergy, Hannover Medical School, Carl-Neuberg Str. 1, 30625 Hannover, Germany.Division of Immunodermatology and Allergy ResearchDepartment of Dermatology and AllergyHannover Medical SchoolCarl-Neuberg Str. 1Hannover30625Germany

Abstract

Background

Atopic dermatitis (AD) is a chronic relapsing skin disease prevalent in 1% to 3% of adults in Western industrialized countries.

Objective

We sought to investigate the effectiveness of educational training in an outpatient setting on coping with the disease, quality of life, symptoms, and severity in adults with AD.

Methods

In this German prospective, randomized controlled multicenter study, adult patients with moderate-to-severe AD were educated by referring to a comprehensive 12-hour training manual consented by a multiprofessional study group from different centers (Arbeitsgemeinschaft Neurodermitisschulung für Erwachsene [ARNE]). Patients were randomly allocated to the intervention or waiting control groups. Study visits were performed at baseline and after 1 year (1 year of follow-up). Primary outcomes were defined as a decrease in (1) “catastrophizing cognitions” with respect to itching (Juckreiz-Kognitions-Fragebogen questionnaire), (2) “social anxiety” (Marburger Hautfragebogen questionnaire), (3) subjective burden by symptoms of the disease (Skindex-29 questionnaire), and (4) improvement of disease signs and symptoms assessed by using the SCORAD index at 1 year of follow-up. Data were analyzed on an intention-to-treat basis.

Results

At 1 year of follow-up, patients from the intervention group (n = 168) showed a significantly better improvement compared with the waiting group (n = 147) in the following defined primary study outcomes: coping behavior with respect to itching (P < .001), quality of life assessed by using the Skindex-29 questionnaire (P < .001), and the SCORAD index (P < .001).

Conclusions

This is the first randomized, controlled multicenter study on patient education in adult AD. The ARNE training program shows significant beneficial effects on a variety of psychosocial parameters, as well as AD severity.

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Key words : Atopic dermatitis, adulthood, patient education, multi-professional, psychosocial, disease severity, quality of life, coping

Abbreviations used : AD, ARNE, DLQI, GADIS, HADS-D, JKF, MHF, QoL, PO-SCORAD

Plan

Methods

Study design

Patients

Patient-education training program

Study procedures

Assessment of sociodemographic data

Questionnaires on coping strategies and possible psychiatric comorbidities

Assessments on QoL

Scoring signs and symptoms of AD

Number of subjects and population for analysis

Sociodemographic and baseline characteristics

Primary end points

Secondary analysis

Discussion

This investigator-initiated study was financially supported in part by Astellas Pharma GmbH. The German Society for Dermatology (Deutsche Dermatologische Gesellschaft) endorsed this study.

Disclosure of potential conflict of interest: A. Wollenberg serves as a consultant for Anacor, Celgene, Galdermam GlaxoSmithKline, LEO Pharma, MedImmune, Novartis, Pierre Fabre, Pfizer, Regeneron, and Sanofi; receives payment for lectures from Bioderma, Galderma, GlaxoSmithKline, Hans Karrer, LEO Pharma, L'Oreal, Medimmune, Novartis, Pierre Fabre, Regeneron, and Sanofi; and receives travel support from Chugai, L'Oreal, Novartis, and Pierre Fabre. M. Sticherling serves on the board for Dupilumab Germany and Serono. C. Apfelbacher serves as a consultant for Cogitando; receives grant support from Siemens Healthcare; receives payments for lectures from European Academy of Dermatology and Venerology; and receives travel support from the European Academy of Allergy and Clinical Immunology, German Society of Intensive Care Medicine, and Austrian Society of Intensive Care Medicine. T. Biedermann serves as a consultant for Novartis and Meda; receives grant support from DFG, Novartis, and Phadia; and receives payments for lectures from ALK-Abelló, Astellas, Bencard, Biogen, Janssen, Leo, Meda, MSD, Novartis, Phadia, and Thermo Fisher. K. Breuer serves on the board from ALK-Abelló; payment for lectures from ALK-Abelló and Thermo Fisher; receives payment for educational presentations from Janssen Cilag; and receives travel support from Novartis. L. Hennighausen receives payment from educational presentation from CK Care Workshop and travel support from CK Care Workshop. J. Ring serves as a consultant for MEDA, Bencord, Novartis, and GlaxoSmithKline. J. Schmitt receives grant support form Novartis, Sanofi, Pfizer, ALK-Abelló, and MSD. E. von Stebut serves as a consultant for Novartis; receives grant support from DFG; and receives payments from Baiersdof. M. Worm serves as a consultant for ALK-Abelló, Arzneimittel GmbH, Meda Pharma GmbH, and Allergopharma GmbH; receives payments from lectures from ALK-Abelló Arzneimittel GmbH, Meda Pharma GmbH, and Allergopharma GmbH; and receives travel support from Meda Pharma GmbH. U. Gieler serves as a consultant for Acne Study; receives payment from lectures from Galderma, Allmirall, GlaxoSmithKline, and Bayer; and receives travel support from EADV, Galderma, AbbVie, Janssen, Novartis, and Lilly. The rest of the authors declare that they have no relevant conflicts of interest.

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Vol 140 - N° 3

P. 845 - septembre 2017 Retour au numéro

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Effects of structured patient education in adults with atopic dermatitis: Multicenter randomized controlled trial - 06/09/17

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