Enhancement of quality of life by a digital therapeutic for people with epilepsy (emyna): protocol of a randomized controlled trial - ELAINE trial (Enhancing QoL in epilepsy with A digital INtervEntion)

Enhancement of quality of life by a digital therapeutic for people with epilepsy (emyna): protocol of a randomized controlled trial - ELAINE trial (Enhancing QoL in epilepsy with A digital INtervEntion) - ELAINE

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

DRKS

Registry ID

DRKS00025828

Enrollment

440

Registered

2021-12-08

Start date

2021-12-13

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

G40

Interventions

Group 1: Intervention group: access to online program emyna Group 2: Control group: Treatment-As-Usual

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: • diagnosis of epilepsy (ICD-10: G40.-, verified by physician’s document), prescribtion of antiseizure medication (ASM) • consent to participation impaired health-related quality of life (< 67 on QOLIE-31 total score)

Exclusion criteria

Exclusion criteria: none

Design outcomes

Primary

Measure	Time frame
Health-related quality of life primarily measured 3 months after baseline, total scores of the Quality of Life in Epilepsy Questionnaire (QOLIE-31). Measured again at 6 months after baseline as follow-up.	—

Secondary

Measure	Time frame
Self-Efficacy Total score of the General Self-Efficacy Scale (GSE). Adherence to Medication Total score of Rief Adherence Index (RAI). General distresss Total score of Depression-Anxiety-Stress-Scales (DASS-21) - revised German version. Ability to Work Total score of Work and Social Assessment Scale (WSAS) - German version. The primary timepoint for acquisition of data about the effectiveness of the intervention will be 3 months after inclusion (T1). 6 months post-allocation will be another timepoint for acquisition of data, treated as a Follow-up for stability of effects.	—

Measure

Time frame

Self-Efficacy Total score of the General Self-Efficacy Scale (GSE). Adherence to Medication Total score of Rief Adherence Index (RAI). General distresss Total score of Depression-Anxiety-Stress-Scales (DASS-21) - revised German version. Ability to Work Total score of Work and Social Assessment Scale (WSAS) - German version. The primary timepoint for acquisition of data about the effectiveness of the intervention will be 3 months after inclusion (T1). 6 months post-allocation will be another timepoint for acquisition of data, treated as a Follow-up for stability of effects.

—

Countries

Germany

Contacts

Public ContactLinda Betz

GAIA AG

team@emyna-studie.de+49 40 3510520

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026