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

(Cost-) effectiveness of a Multi-Component Intervention for adults with epilepsy: a Dutch randomized controlled trial - ZMILE (Self-management intervention: Living with Epilepsy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON40155
Enrollment
100
Registered
2013-12-04
Start date
2014-04-08
Completion date
Unknown
Last updated
2024-04-29

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

Conditions

epilepsie Epilepsy

Interventions

MULTICOMPONENT INTERVENTION The components of the MCI are methods of enhancing self-management skills & usages of different eHealth tools, which can be used to (self) monitor their condition. Gro

Sponsors

Universiteit Maastricht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

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 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.

Design outcomes

Primary

MeasureTime frame
The primary outcome for the (cost) effectiveness study is self-efficacy measured with Epilepsy Self-Efficacy Scale (ESES);

Secondary

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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)