title: (Cost)-effectiveness of a multi-component intervention for adults with epilepsy: study protocol of a Dutch randomized controlled trial (ZMILE study).
abstract: BACKGROUND
  In patients with epilepsy, poor adherence to anti-epileptic drugs has been shown to be the most important cause of poorly controlled epilepsy. Furthermore, it has been noted that the quality of life among patients with epilepsy can be improved by counseling and treatments aimed at increasing their self-efficacy and concordance, thus stimulating self-management skills. However, there is a need for evidence on the effectiveness of such programs, especially within epilepsy care. Therefore, we have developed a multi-component intervention (MCI) which combines a self-management/education program with e-Health interventions. Accordingly, the overall objective of this study is to assess the (cost)-effectiveness and feasibility of the MCI, aiming to improve self-efficacy and concordance in patients with epilepsy.
  
  
  METHODS
  A RCT in two parallel groups will be conducted to compare the MCI with a control condition in epilepsy patients. One hundred eligible epilepsy patients will be recruited and allocated to either the intervention or control group. The intervention group will receive the MCI consisting of a self-management/education program of six meetings, including e-Health interventions, and will be followed for 12 months. The control group will receive care as usual and will be followed for 6 months, after which patients will be offered the possibility of participating in the MCI. The study will consist of three parts: 1) a clinical effectiveness study, 2) a cost-effectiveness study, and 3) process evaluation. The primary outcome will be self-efficacy. Secondary outcomes include adherence, side effects, change in seizure severity & frequency, improved quality of life, proactive coping, and societal costs. Outcome assessments will be done using questionnaires at baseline and after 3, 6, 9, and 12 months (last two applicable only for intervention group).
  
  
  CONCLUSIONS
  In times of budget constraints, MCI could be a valuable addition to the current healthcare provision for epilepsy, as it is expected that higher concordance and self-efficacy will result in reduced use of healthcare resources and an increased QOL. Accordingly, this study is aimed helping patients to be their own provider of health care, shifting epilepsy management from professionals to self-care by patients equipped with appropriate skills and tools.
  
  
  BACKGROUND
  NTR4484 .
authors.affiliation: CAPHRI School for Public Health and Primary Care, Maastricht University, P.O. Box 616, 6200 MD, Maastricht, the Netherlands. leenenl@kempenhaeghe.nl.|Department of Health Services Research, Maastricht University, Duboisdomein 30, 6229 GT, Maastricht, the Netherlands. leenenl@kempenhaeghe.nl.|Department of Research & Development, Epilepsy Centre Kempenhaeghe, Heeze, the Netherlands. leenenl@kempenhaeghe.nl.
authors.forename: Loes Am
authors.initials: LA
authors.lastname: Leenen
authors.affiliation: CAPHRI School for Public Health and Primary Care, Maastricht University, P.O. Box 616, 6200 MD, Maastricht, the Netherlands. b.wijnen@maastrichtuniversity.nl.|Department of Health Services Research, Maastricht University, Duboisdomein 30, 6229 GT, Maastricht, the Netherlands. b.wijnen@maastrichtuniversity.nl.|Department of Research & Development, Epilepsy Centre Kempenhaeghe, Heeze, the Netherlands. b.wijnen@maastrichtuniversity.nl.
authors.forename: Ben Fm
authors.initials: BF
authors.lastname: Wijnen
authors.affiliation: CAPHRI School for Public Health and Primary Care, Maastricht University, P.O. Box 616, 6200 MD, Maastricht, the Netherlands. reina.dekinderen@maastrichtuniversity.nl.|Department of Health Services Research, Maastricht University, Duboisdomein 30, 6229 GT, Maastricht, the Netherlands. reina.dekinderen@maastrichtuniversity.nl.|Department of Research & Development, Epilepsy Centre Kempenhaeghe, Heeze, the Netherlands. reina.dekinderen@maastrichtuniversity.nl.
authors.forename: Reina Ja
authors.initials: RJ
authors.lastname: de Kinderen
authors.affiliation: Department of Research & Development, Epilepsy Centre Kempenhaeghe, Heeze, the Netherlands. majoiem@kempenhaeghe.nl.|Department of Neurology, Academic Centre for Epileptology, Epilepsy Centre Kempenhaeghe & Maastricht University Medical Centre, Maastricht, The Netherlands. majoiem@kempenhaeghe.nl.|MHENS, School for Mental Health and Neuroscience, department of Psychiatry and Neuropsychology, Maastricht University Medical Centre, Maastricht, the Netherlands. majoiem@kempenhaeghe.nl.
authors.forename: Marian Hjm
authors.initials: MH
authors.lastname: Majoie
authors.affiliation: MHENS, School for Mental Health and Neuroscience, department of Psychiatry and Neuropsychology, Maastricht University Medical Centre, Maastricht, the Netherlands. c.vanheugten@maastrichtuniversity.nl.|Department of Neuropsychology and Psychopharmacology, Maastricht University, Maastricht, the Netherlands. c.vanheugten@maastrichtuniversity.nl.
authors.forename: Caroline M
authors.initials: CM
authors.lastname: van Heugten
authors.affiliation: CAPHRI School for Public Health and Primary Care, Maastricht University, P.O. Box 616, 6200 MD, Maastricht, the Netherlands. s.evers@maastrichtuniversity.nl.|Department of Health Services Research, Maastricht University, Duboisdomein 30, 6229 GT, Maastricht, the Netherlands. s.evers@maastrichtuniversity.nl.|Trimbos Institute, Netherlands Institute of Mental Health and Addiction, Utrecht, the Netherlands. s.evers@maastrichtuniversity.nl.
authors.forename: Silvia Maa
authors.initials: SM
authors.lastname: Evers
mesh_terms: D000223:Adaptation, Psychological; D000927:Anticonvulsants / Q000627:therapeutic use*; D001007:Anxiety / Q000523:psychology; D003362:Cost-Benefit Analysis; D003863:Depression / Q000523:psychology; D004827:Epilepsy / Q000191:economics / Q000523:psychology / Q000628:therapy*; D006801:Humans; D055118:Medication Adherence; D063731:Mobile Applications; D009426:Netherlands; D010353:Patient Education as Topic / Q000379:methods; D011788:Quality of Life; D012107:Research Design; D012648:Self Care / Q000191:economics / Q000379:methods*; D020377:Self Efficacy; D011795:Surveys and Questionnaires; D017216:Telemedicine
chemical_list: D000927:Anticonvulsants