Self-management education for adults with poorly controlled epilepsy

• Register: ISRCTN
• Last refreshed on: 5 June 2018
• Main ID: ISRCTN57937389
• Date of registration: 27/03/2013
• Prospective Registration: Yes
• Primary sponsor: Institute of Psychiatry, King?s College London (UK)
• Public title: Self-management education for adults with poorly controlled epilepsy
• Scientific title: Self-Management education for adults with poorly controlled epILEpsy (SMILE): a project involving a randomised controlled trial
• Date of first enrolment: 28/05/2013
• Target sample size: 468
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN57937389
• Study type: Interventional
• Study design: Mixed-methods project. Following a pilot to optimise MOSES for UK delivery, a single-blind RCT of MOSES, with a nested qualitative component (plus TAU) vs TAU (Quality of life)
• Phase: Not Applicable

Countries of recruitment

United Kingdom

Contacts

• Name: Leone Ridsdale

Key inclusion & exclusion criteria

Inclusion criteria: 1. Patient has a documented diagnosis of epilepsy (all epilepsy syndromes and all types of focal and generalised seizures will be permitted
2. Currently being prescribed antiepileptic drugs
3. Aged =16 years (no upper age limit)
4. Able to provide informed consent, participate in the workshops and complete the questionnaires in English
5. Had at least 2 seizures in previous 12 months (as reported by patient)
Exclusion criteria: 1. Have actual/suspected psychogenic nonepileptic seizures only
2. Have acute symptomatic seizures related to acute neurological illness or substance misuse
3. Has a severe psychiatric disorders (e.g., psychosis) or terminal medical condition
4. Are enrolled in other nonpharmacological epilepsy treatment studies

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Epilepsy/Neurology
Nervous System Diseases
Epilepsy

Intervention(s)

Following optimisation for UK delivery, a single-blind RCT will compare effect of MOSES (plus treatment as usual TAU) to TAU alone.

Active treatment MOSES: We shall run ~21 MOSES courses for those randomised to the active treatment arm. The time between randomisation and receipt of MOSES will be ~=1 month. Eight to twelve participants will be invited to each course (with 2-3 carers if requested by the patients). Two health professionals will facilitate each course. Each will have completed an English translation of the formalised training programme used in Germany to train people to deliver MOSES. At least one of the facilitators will have a medical background so as to be able to provide appropriate care should a participant have a seizure. With participants? consent, MOSES sessions will be audio-recorded to allow us to assess treatment fidelity and to permit ongoing supervision.

MOSES consists of a number of components with a range of training modules. It is a complex intervention. Materials for the delivery of MOSES include a detailed workbook for participants. MOSES is subdivided into nine modules for delivery, designed to improve participants? knowledge of epilepsy in terms of its diagnosis, treatment and consequences and to improve understanding of associated psychosocial and occupational difficulties16. The modules cover:
i) Living with epilepsy: Recognising, expressing emotions about and coping with epilepsy;
ii) Epidemiology: Prevalence and age-related incidence of epilepsy;
iii) Basic knowledge: Causes, pathophysiology, types of seizures;
iv) Diagnosis: Important diagnostic tools. Importance of exact descriptions and documentation of seizures for the doctor;
v) Treatment: Various treatment possibilities, guidelines and approaches with AEDs, importance of AED compliance to achieve better seizure control;
vi) Self-control: How to influence and prevent the occurrence of epileptic seizures; recognition and avoidance of provoking factors;
vii) Prognosis:

Primary Outcome(s)

The primary outcome measure for this project is quality of life (QOL) measured at 12 month follow-up in this project's randomised controlled trial (Phase 2 of the project). QoL will be measured using a standardised and psychometrically robust epilepsy-specific measure, called the QOLIE31 (Cramer et al., 1998). The QOLIE31 comprises seven subscales seizure worry, emotional wellbeing, energy fatigue, cognitive functioning, medication effects, social functioning, overall QOL. This measure is to be completed at assessments 1 (baseline), 2 (6 month follow-up) and 3 (12 month follow-up).

Secondary Outcome(s)

The secondary outcome measures are the following which will be completed as part of the project's randomised controlled trial component (Phase 2 of the project):
1. Seizure control (seizure frequency over the previous 6/12 months and seizure recency through reports of time since last seizure; Thapar et al., 2009). This measure is to be completed at assessments 1, 2 and 3
2. Impact (Impact Scale measuring self-perceived impact of epilepsy on relationships, social and occupational activities, personal health and aspirations, and standard of living; Jacoby et al., 1993). This measure is to be completed at assessments 1, 2 and 3
3. Medication adherence (medication adherence subscale from the Epilepsy Self management Scale; Dilorio et al., 2009). To be completed at assessments 1 and 3 only
4. Medication adverse effects (during the past 4 weeks, how much have you been bothered by (a) physical effects of antiepileptic medication and (b) mental effects of antiepileptic medication?; Cramer et al., 1998). To be completed at assessments 1 and 3 only
5. Psychological distress (Hospital Anxiety and Depression Scale; Zigmond & Snaith, 1983). To be completed at assessments 1 and 3 only
6. Perceived stigma (Stigma of Epilepsy Scale; Jacoby, 1994). To be completed at assessments 1 and 3 only
7. Mastery/control over epilepsy(epilepsy specific scale; Wagner et al., 1995). To be completed at assessments 1 and 3 only
8. To permit an assessment of the cost effectiveness of the intervention, participants will report their use of different health services and work status over the prior 6months (Modified Client Service Receipt Inventory; Beecham over the prior 6months (Modified Client Service Receipt Inventory; Beecham & Knapp, 2001) and to complete the EuroQoL health status measure (EQ5D; The EuroQol Group, 1990). To be completed at assessments 1 and 3 only

Secondary ID(s)

1; HTA 09/165/01

Source(s) of Monetary Support

Health Technology Assessment Programme

Ethics review

Status:
Approval date:
Contact:

National Research Ethics Service, NRES Committee London - Fulham, REC ref: 12/LO/1962

Results

• Results available: Yes
• Date Completed: 07/07/2016