Extrait

Background and study aims People with epilepsy want more support in learning how to self-manage their condition. Group patient education courses are one way this is achieved for other chronic conditions and are offered as part of routine NHS care. A promising course for epilepsy called MOSES is used in Germany. When tested in German-speaking countries, it resulted in improved patient knowledge about epilepsy, better seizure control and coping and tolerance of medication. MOSES consists of patients receiving a workbook and completing a 2-day course in groups of 8 to 12 people. The developers of MOSES have translated it into English. We aim to first adapt MOSES for delivery in the NHS context (initial study called a pilot) and then test how helpful it is for people with epilepsy in the UK (larger study called a randomised controlled trial). Who can participate? Pilot Phase: We shall run 2 pilot MOSES courses. We will recruit about 20 participants to attend these courses. Participants will be recruited via an advertisement on the British Epilepsy Association’s website and in their user magazine. To participate a person needs to have a diagnosis of epilepsy (all epilepsy syndromes and seizures types permitted); be being prescribed anti-epileptic drugs; aged 16 years or over (no upper age limit); have experienced more than 2 seizures in the past 12 months (of any type); be able to provide informed consent, participate in the workshops and complete questionnaires in English; and live in the London area. People who have a severe psychiatric disorder (e.g., psychosis) or a terminal medical condition will not be able to participate. Randomised Controlled Trial Phase: We shall recruit 428 people with epilepsy from 16 specialist hospital clinics from South-east England. This will compare how helpful the adapted MOSES programme (plus standard medical care) is compared to standard medical care alone. To take part, a person needs to have a documented diagnosis of epilepsy (all epilepsy syndromes and seizures types are permitted); be prescribed anti-epileptic drugs, be aged 16 years or over (no upper age limit); be able to provide informed consent, participate in the workshops and complete the questionnaires in English; and have had at least 2 seizures in previous 12 months (as reported by patient). A person will not be able to take part if they have actual/suspected psychogenic non-epileptic seizures only; have acute symptomatic seizures related to acute neurological illness or substance misuse; have a severe psychiatric disorder (e.g., psychosis) or terminal medical condition; and/ or are enrolled in another epilepsy-related non-pharmacological treatment study. What does the study involve? Pilot Phase: The pilot courses shall be run at our university. Ten participants will attend each course (with 2-3 carers if patients request this). A research worker will observe each course to record their impressions. Participants will feedback on the intervention, its content and cultural acceptability by means of focus groups held on the final day of the course. Participants will also be invited to return 2-3 weeks later for individual interview and to complete the questionnaires to be used in the trial. Taxis will be arranged for participants’ and refreshments will be provided. Randomised Controlled Trial Phase: The duration of the trial for a participant is 12 months. Using standard self-report questionnaires, participants will be assessed at recruitment (assessment 1), and then again 6- (assessment 2) and 12-months later (assessment 3). Areas assessed by the questionnaires include Quality of life in epilepsy, seizure control, psychological distress, confidence managing epilepsy and health service use. A computer programme will randomly allocate patients to the MOSES programme (plus standard medical care) or to the standard medical care alone (this will be done remotely after assessment 1). Patients will be instructed not to tell research workers which group they have been allocated to. We shall run approximately 21 MOSES courses. The time between randomisation and receipt of MOSES will be less than one month. Eight to twelve participants will be invited to each course (with two or three 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 persons to deliver MOSES. With participants’ consent, MOSES sessions will be audio-recorded to allow us to assess treatment fidelity and to permit ongoing supervision. Once all 12 month follow-up data has been collected, delayed-MOSES courses will be run for those in the standard-medical care only group. What are the possible benefits and risks of participating? The overall benefit of the study is the opportunity for people with epilepsy to engage in self-management education to potentially enable them to better manage their epilepsy and improve their quality of life. A potential benefit for society will be cost savings for NHS resources. There are no known disadvantages or risks of taking part. The course is routinely given to people with epilepsy in other countries. However, the course and some of the questionnaires involve participants thinking about epilepsy and feelings. For some people, this can be upsetting. They can stop taking part in the course or doing the questionnaire at any time. This would not affect their medical care. If taking part in the course or answering the questionnaires makes a participant worried about their feelings, they can talk to their GP. They can also ask the health professionals giving their MOSES course for advice. Where is the study run from? The study is being done by the Clinical Neuroscience Department at King's College London, UK. When is the study starting and how long is it expected to run for? The project will start on the 1st of June 2013 and is expected to run for 35 months. Who is funding the study? The study is funded by the National Institute for Health Research (NIHR). Additional support is being provided by King’s College Hospital NHS Foundation Trust, UK. Who is the main contact? 1. Professor Leone Ridsdale ([email protected]; +44 (0)20 7848 0293) 2. Professor Laura Goldstein ([email protected]; +44 (0)20 7848 0218)

Critère d'inclusion

• Epilepsy/Neurology

Liens

• ictrp
• isrctn