LEONIDaS Caregivers Study

NCT ID: NCT05140122

Last Updated: 2023-12-14

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-10-26
• Study Completion Date: 2023-10-26

Brief Summary

Dravet syndrome is a rare form of severe epilepsy that begins in the first year of life and is associated with frequent and/or prolonged seizures. Individuals with Dravet Syndrome often experience a range of comorbidities, including behavioral and developmental delays, movement and balance issues, sleep difficulties, chronic infections, and growth and nutritional issues. Patients with Dravet syndrome are at high risk of death due to SUDEP (Sudden Unexpected Death in Epilepsy), prolonged seizures, seizure-related accidents, and infections.

Due to the severity of this condition, parents of children with Dravet syndrome are typically highly involved in their child's 24-hour care and this has a considerable impact on family life. Recent studies have highlighted the profound impact that such caregiving has on physical health, mental health, social function and financial resources. In particular, caregivers report high levels of stress and anxiety, fatigue, depression and social isolation. However, there is currently a lack of effective interventions to reduce the negative impact of caregiving on caregivers.

The aim of this study is to prospectively study carers of individuals with Dravet syndrome to identify pharmacological and psychological factors that are associated with increased or decreased vulnerability to stress, depression and anxiety. Using a naturalistic, observational design the investigators will assess a cohort of Dravet Syndrome carers every six months for 3 years in order to further characterise trajectories of caregiver burden and the factors that influence this, including factors related to the person with Dravet syndrome (e.g. age, seizure frequency/severity, treatment/medications, comorbidities) and factors related to the carer and family environment (e.g. social engagement/isolation, fatigue, finances, relationships). The investigators will use both standardized questionnaires and a neurocognitive task (Facial Expression Recognition Task) to assess vulnerability to anxiety and depression. The study will be conducted online.

Conditions

Dravet Syndrome; Depression; Anxiety

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Primary caregivers of individuals with Dravet Syndrome

Multiple

Intervention Type: DRUG

We will collect information on all medications taken by the caregiver and the person they care for.

Multiple

Intervention Type: OTHER

We will collect information on all forms of therapy or medical intervention taken by the caregiver and the person they care for.

Interventions

Multiple

We will collect information on all medications taken by the caregiver and the person they care for.

Intervention Type: DRUG

Multiple

We will collect information on all forms of therapy or medical intervention taken by the caregiver and the person they care for.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Willing and able to give informed consent for participation in the study
• Aged 18 years or above
• Primary caregiver of an individual with a medical history supporting a clinical diagnosis of Dravet syndrome
• Able to access the internet

Exclusion Criteria

• Inability to provide informed written consent
• Another caregiver of the same individual with Dravet is already enrolled in the study

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.

INDUSTRY

Sponsor Role: collaborator

University of Oxford

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Catherine Harmer, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Oxford

Other Identifiers

R76178/RE001

Identifier Type: -

Identifier Source: org_study_id