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

Sponsor
University Hospital, Toulouse
Study ID
NCT07507240
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Apr 2, 2026
Start date
May 1, 2026
Status verified
Mar 2026
Primary completion
Nov 1, 2027
Completion
May 1, 2028

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Patients with remote monitoring
    Patients who will benefit from remote monitoring to support them in their changes to antiepileptic treatment
  • Active Comparator: Patients without remote monitoring
    Patients who will receive standard care without remote monitoring as part of a change in anti-epileptic treatment

Primary Outcome Measure

Describe the evolution of therapeutic adherence [ Time Frame: 6 months after the inclusion ]

Central Contacts

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