The Benefits of a Care Pathway Combining Remote Monitoring and Support From a Nurse After a Change in Anti-epileptic Treatment: a Pilot Study

Официальное название

The Benefits of a New Care Pathway Combining Remote Monitoring and Support From a Nurse for Epileptic Patients After a Change in Anti-epileptic Treatment: a Pilot Study

Обзор

Epilepsy is a chronic condition affecting approximately 600,000 people in France. Epilepsy treatment relies on antiepileptic drugs, the effectiveness of which depends on adherence to medication schedule, with missed doses increasing the risk of seizures. As with any chronic illness, epilepsy presents a significant challenge in terms of treatment adherence. Furthermore, despite good medication adherence, 30% of patients remain drug-resistant. Therefore, the aim is to create a remote monitoring program, supported by a nurse, lasting six months after the introduction of a new antiepileptic drug, to support the patient until their next appointment with a neurologist. This system would optimize and secure the care pathway during treatment changes by improving the detection of side effects and/or a resurgence of seizures requiring medication adjustments.

Вмешательства

• Другое Remote monitoring training
  Training in the care pathway via remote monitoring software
• Другое Description of the standard care pathway
  Description of the standard care pathway with the nurse
• Другое Therapeutic support with a nurse
  Therapeutic support with a nurse who ensures the patient's adherence to remote monitoring at 1 month and 3 months
• Диагностический тест Questionnaires for the two groups
  Quality of life questionnaires at baseline and at 6 months
• Другое Satisfaction questionnaire for the group with remote monitoring
  Satisfaction questionnaire for the group with remote monitoring at 6 months

Первичные конечные точки

• Describe the evolution of therapeutic adherence [Срок оценки: 6 months after the inclusion]

Вторичные конечные точки (5)

• Evolution of Quality of Life between baseline and 6 months [Срок оценки: 6 months after the inclusion]
• Description of the care pathway between baseline and 6 months [Срок оценки: 6 months after the inclusion]
• Description of patient satisfaction with their medical care [Срок оценки: 6 months after the inclusion]
• Evaluation of patient acceptability of remote monitoring [Срок оценки: 6 months after the inclusion]
• Evaluation of satisfaction with the use of remote monitoring by the healthcare team [Срок оценки: 6 months after the inclusion]

Критерии участия

Критерии включения

• Confirmed diagnosis of epilepsy by a neurologist
• Patient requiring the introduction of anti-epileptic medication as an add-on to their usual treatment or as a replacement for their current treatment(s)
• Access to a reliable internet connection and a compatible device for remote monitoring (smartphone, tablet, computer)
• Ability to understand and use remote communication technologies

Критерии исключения

• Presence of concurrent neurological or psychiatric disorders affecting the ability to use remote monitoring.
• Presence of a progressive neurological disease, including degenerative CNS disease, or a progressive tumor.
• Change in treatment for pregnancy preparation.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

Франция · 1 центр

• Cerebral electrophysiology, epilepsy and sleep, Purpan Hospital, Place du Docteur Baylac — Toulouse

Идентификаторы

NCT: NCT07507240 · RC31/25/0401 · ID-RCB

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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