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Self-management Intervention for adults with epilepsy

(Cost-) effectiveness of a Multi-Component Intervention for adults with epilepsy: a Dutch randomized controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON25737
Enrollment
100
Registered
2014-04-02
Start date
2014-04-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epilepsy, Epilepsie

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-e

Sponsors

Maastricht University School for Public Health and Primary Care (Caphri). Department of Health Services Research Postbus 616 6200MD Maastricht
Lead Sponsor

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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)

Contacts

Public ContactL.A.M. Leenen

Verpleegkundig Specialist (Nurse Practitioner) Kempenhaeghe, Centre for Epilepsy Sterkselseweg 65

+31 40 2279022

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)