Self-management Intervention for adults with epilepsy|
|- candidate number||17124|
|- NTR Number||NTR4484|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||2-apr-2014|
|- Secondary IDs||METC ID: NL44203.068.13 ZonMW number 836011018|
|- Public Title||Self-management Intervention for adults with epilepsy|
|- Scientific Title||(Cost-) effectiveness of a Multi-Component
Intervention for adults with epilepsy: a Dutch
randomized controlled trial|
|- ACRONYM||ZMILE (Zelfmanagement Interventie Leven met Epilepsie)|
|- hypothesis||We believe that self-management can be a (cost) effective way to improve patients’ ability to cope with their disease which can result, among others, in improved self-efficacy, adherence, and disease specific and generic quality of life.
|- Healt Condition(s) or Problem(s) studied||Epilepsy, Selfmanagement|
|- Inclusion criteria||- Diagnosed with epilepsy
- Using anti-epileptic drugs
- Age at least 18 years
- Living at home (Netherlands)
- Able and willing to use a Smartphone in the program.
- Able to provide informed consent |
|- Exclusion criteria||- Insufficient mental ability to understand, learn from and profit from the self-management
treatment on the basis of clinical judgement of the treating neurologist.
- Insufficient command of the Dutch language based on clinical judgement.
- Inability to function in a group because of mood or behavioural problems as assessed
by the neurologist. |
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-apr-2014|
|- planned closingdate||1-jan-2016|
|- Target number of participants||100|
|- Interventions||A multi component intervention (MCI), which combines a self-management/education program with eHealth interventions (apps and Medication Event Monitoring System) aiming to improve
adherence to Anti-epileptic drugs.|
|- Primary outcome||1) Epilepsy Self-Efficacy Scale-33 items (ESES). The ESES is a 33-item scale that measures different aspects of efficacy within the self-management of epilepsy. The items represent three dimensions of self-management: medication management, seizure management, and general management including safety and health. Items are rated on an 11-point Likert rating scale, ranging from 0, “not at all certain I can do”, to 10, “very certain I can do”. The total possible scores for the ESES range from 0 to 330. Higher scores correspond to higher levels of confidence in ability to manage epilepsy. |
|- Secondary outcome||2) Adherence, which will be determined using: 1) MEMS. Electronic monitoring, such as MEMS has been proposed as a possible “gold standard” for medication adherence measurement, and 2) the Medication Adherence Rating Scale (MARS-5), which measures self-reported adherence.
3) General self-efficacy, which will be determined using the Dutch adaptation of the general Self-Efficacy Scale (GSES). The GSES consists of 10 items assessed on a 4-point scale, ranging from ‘totally wrong’ to ‘totally true’. The scale was designed to assess self-efficacy, i.e., the belief that one’s actions are responsible for successful outcomes. The scaled score for each question ranges from 1 to 4. Higher scores indicate stronger patient’s belief in self-efficacy.
4) Seizure frequency will be determined using a short questionnaire regarding seizure frequency covering the past 4 weeks. The questions mainly focus on the number of seizures, whether the person documents his/her seizures and in what way the person documents his/her seizures.
5) Seizure severity, which will be determined using the National Hospital Seizure Severity Scale (NHS3). The NHS3 contains seven seizure-related factors and generates a score from 1 to 27, in which a higher score represents a more severe seizure.
6) Adverse events, which will be determined using the SIDe-effect of AntiEpileptic Drugs questionnaire (SIDAED). The SIDAED consists of 46 items with possible AED-related complaints. These items form 10 categories: general CNS, behavior (increased irritability), depressive symptoms, cognitive function, motor problems and co-ordination, visual complaints, headache, cosmetic and dermatological complaints, gastrointestinal complaints, and sexuality and menses. For each item the patient rates the severity of the complaint on a four- point Likert scale (no problem, mild, moderate, or serious problem). In addition, the duration of the complaints is scored (since a few weeks, since months or half a year or longer).
7) Depression/Anxiety, which will be determined using the Hospital Anxiety and Depression Scale (HADS). The HADS has a total of 14 items, each scored on a scale of 0-3, with 3 indicating higher symptom frequencies. Scores for each subscale (anxiety and depression) can range from 0-21 and scores for the entire scale (emotional distress) range from 0-42, with higher scores indicating more distress.
8) Self-rated proactive Coping, which will be determined using the Utrecht Proactive Coping Competence Scale (UPPC). A total of 21 items are assessed on a 4-point scale ranging from ‘not competent at all’ to ‘very competent’. Total scores are calculated by averaging the 99 individual item scores. Higher scores on the UPCC indicate higher levels of perceived proactive coping competencies.
9) Disease specific quality of life will be measured with the Quality Of Life in Epilepsy-patient-weighted (QOLIE-31-P). The QOLIE-31-P consists of 38 items assessing 7 domains of Seizure Worry, Overall QOL, Emotional well-being, Energy-Fatigue, Cognitive Functioning, Medication effects, Social Functioning and an Overall Score. In addition, for each domain, questions regarding how much distress a person feels about problems and worries related to epilepsy are included. Higher values indicate a better Quality of life.
10) Generic quality of life will be assessed with the EuroQoL-5 dimensions (EQ-5D-5L). The EQ-5D-5L consists of five dimensions, mobility, self-care, usual activities, pain/discomfort, anxiety/depression, each of which can take one of five responses. Utilities derived from the EQ-5D-5L will be used in the QALY calculation, using the currently developed Dutch algorithm.
11) Societal costs will be measured retrospectively with the a medical Cost Questionnaire (MCQ), an adapted version of the Trimbos/iMTA questionnaire for costs associated with psychiatric illness and the Productivity Cost Questionnaire (PCQ) each covering 3 months.
|- Timepoints||Possible candidates for this study will be recruited from the outpatient clinic of
Kempenhaeghe. Patients receive a face-to-face interview with the researcher in which the
study is explained in detail. After patients have given informed consent, baseline
measurements (T0) are conducted. After this baseline measurements randomisation will
take place. Patients are either assigned to the intervention group or the CAU control
group. Participants are told that a group will start as soon as 4-6 patients are recruited for
each group. The expectation is that this will only last a few weeks. Once sufficient
patients have been randomised, the MCI intervention is offered to the intervention group
during a 9-week period. After finishing the intervention and at established follow up
outcome measurements are conducted by sending the questionnaires to the participant’s home. Participants are asked to fill in the
questionnaires and bring them with them when visiting a scheduled standard 3-monthly
visit of the outpatient clinic. The researcher contacts the participant during these visits
and asks them to provide missing information. |
|- Trial web site|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| L.A.M. Leenen|
|- CONTACT for SCIENTIFIC QUERIES|| B.F.M. Wijnen|
|- Sponsor/Initiator ||University Maastricht (UM), CAPHRI Research Institute|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||Background: Epilepsy is a chronic disorder of the brain characterized by recurrent seizures, which are the result of excessive electrical discharges in the brains. It is estimated that only 70-80% of newly diagnosed adults with epilepsy can be successfully treated with anti-epileptic drugs. In epilepsy patients, poor adherence has been shown to be the most important cause of poorly controlled epilepsy. Furthermore it is emphasized that an increase in quality of life among patients with epilepsy could be reached by counseling and treatment aimed at increasing their self-efficacy. However, there is a need for evidence-based programs within epilepsy care. Hence the overall objective of this study is to assess the (cost-) effectiveness of a multi-component intervention (MCI; self-management/education program & e-health) aiming to improve self-efficacy and adherence in people with epilepsy compared to care as usual.
Methods/design: A randomized controlled trial in 2 parallel groups will be conducted to compare the MCI intervention with a waiting list control condition in epilepsy patients. One hundred eligible epilepsy patients will be recruited from the Kempenhaeghe epilepsy center and allocated to intervention or control group. Patients in the intervention group will be followed for 12 months and patients in the control group will be followed for 6 months. The study will consist of three parts: 1) a clinical effectiveness study, 2) a cost-effectiveness study, and 3) a process evaluation. The primary outcome will be self-efficacy. Other outcomes include: adherence, seizure severity & frequency, emotional functioning, quality of life, proactive coping, side effects, and health care resource use. Outcome assessments will be done using questionnaires at baseline and after 3, 6, 9, and 12 months.
Discussion: This study will determine the (cost-) effectiveness of a MCI intervention to improve the management of epilepsy in adult patients. The MCI is designed to stimulate self-management skills and awareness of epilepsy patients in combination with the use of e-health interventions. Hence, this study is aimed at patients, making them their own provider of health care and thus shifting management from professionals to self-care by patient equipped with appropriate tools and training.
|- Main changes (audit trail)|
|- RECORD||2-apr-2014 - 25-apr-2014|
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