Self-management Intervention for adults with epilepsy

Background: Epilepsy is a chronic disorder of the brain characterized by recurrent seizures, which are the result of excessive electrical discharges in the brains. It is estimated that only 70-80% of newly diagnosed adults with epilepsy can be successfully treated with anti-epileptic drugs. In epilepsy patients, poor adherence has been shown to be the most important cause of poorly controlled epilepsy. Furthermore it is emphasized that an increase in quality of life among patients with epilepsy could be reached by counseling and treatment aimed at increasing their self-efficacy. However, there is a need for evidence-based programs within epilepsy care. Hence the overall objective of this study is to assess the (cost-) effectiveness of a multi-component intervention (MCI; self-management/education program & e-health) aiming to improve self-efficacy and adherence in people with epilepsy compared to care as usual.

Methods/design: A randomized controlled trial in 2 parallel groups will be conducted to compare the MCI intervention with a waiting list control condition in epilepsy patients. One hundred eligible epilepsy patients will be recruited from the Kempenhaeghe epilepsy center and allocated to intervention or control group. Patients in the intervention group will be followed for 12 months and patients in the control group will be followed for 6 months. The study will consist of three parts: 1) a clinical effectiveness study, 2) a cost-effectiveness study, and 3) a process evaluation. The primary outcome will be self-efficacy. Other outcomes include: adherence, seizure severity & frequency, emotional functioning, quality of life, proactive coping, side effects, and health care resource use. Outcome assessments will be done using questionnaires at baseline and after 3, 6, 9, and 12 months.

Discussion: This study will determine the (cost-) effectiveness of a MCI intervention to improve the management of epilepsy in adult patients. The MCI is designed to stimulate self-management skills and awareness of epilepsy patients in combination with the use of e-health interventions. Hence, this study is aimed at patients, making them their own provider of health care and thus shifting management from professionals to self-care by patient equipped with appropriate tools and training.

We believe that self-management can be a (cost) effective way to improve patients’ ability to cope with their disease which can result, among others, in improved self-efficacy, adherence, and disease specific and generic quality of life.

Possible candidates for this study will be recruited from the outpatient clinic of
Kempenhaeghe. Patients receive a face-to-face interview with the researcher in which the
study is explained in detail. After patients have given informed consent, baseline
measurements (T0) are conducted. After this baseline measurements randomisation will
take place. Patients are either assigned to the intervention group or the CAU control
group. Participants are told that a group will start as soon as 4-6 patients are recruited for
each group. The expectation is that this will only last a few weeks. Once sufficient
patients have been randomised, the MCI intervention is offered to the intervention group
during a 9-week period. After finishing the intervention and at established follow up
outcome measurements are conducted by sending the questionnaires to the participant’s home. Participants are asked to fill in the
questionnaires and bring them with them when visiting a scheduled standard 3-monthly
visit of the outpatient clinic. The researcher contacts the participant during these visits
and asks them to provide missing information.

A multi component intervention (MCI), which combines a self-management/education program with eHealth interventions (apps and Medication Event Monitoring System) aiming to improve
adherence to Anti-epileptic drugs.