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

Completed

• Conditions: epilepsie; Epilepsy

• Registration Number: NL-OMON40155
• Lead Sponsor: niversiteit Maastricht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2016-11-16
• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 102

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 intervention 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome for the (cost) effectiveness study is self-efficacy<br /><br>measured with Epilepsy Self-Efficacy Scale (ESES); </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcomes for the (cost)-effectiveness study are adherence measured by<br /><br>Monitor Adherence Response Scale (MARS) and Medication Event Monitoring System<br /><br>(MEMS), general self-efficacy measured by Generalized Self-efficacy Scale<br /><br>(GSES) and generic quality of life as measured with the EuroQol-5D and the<br /><br>AQOL-8D.<br /><br><br /><br>Other outcome measures are side effects, depression/mood, quality of life,<br /><br>coping skills, societal costs, seizure frequency.</p><br>