LEONIDaS Caregivers Study

Sponsor
University of Oxford (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05140122
Collaborator
Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc. (Industry)
500
72

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

Study Design

Study Type:
Observational
Anticipated Enrollment :
500 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
The LEONIDaS(Long Term Exploration of Outcomes From New Interventions in Dravet Syndrome) Caregivers Study
Anticipated Study Start Date :
Jan 1, 2022
Anticipated Primary Completion Date :
Dec 31, 2027
Anticipated Study Completion Date :
Dec 31, 2027

Arms and Interventions

Arm Intervention/Treatment
Primary caregivers of individuals with Dravet Syndrome

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

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

Outcome Measures

Primary Outcome Measures

  1. Anxiety and depression scores on the Hospital Anxiety and Depression Scale (HADS) [Follow up at three years]

    Higher scores indicate higher symptom levels (worse outcome)

  2. Anxiety and depression scores on the Hospital Anxiety and Depression Scale (HADS) [Follow up at two years]

    Higher scores indicate higher symptom levels (worse outcome)

  3. Anxiety and depression scores on the Hospital Anxiety and Depression Scale (HADS) [Follow up at one year]

    Higher scores indicate higher symptom levels (worse outcome)

  4. Caregiver stress scores on the UW Caregiver Stress Scale [Follow up at three years]

    Higher scores indicate higher symptom levels (worse outcome)

  5. Caregiver stress scores on the UW Caregiver Stress Scale [Follow up at two years]

    Higher scores indicate higher symptom levels (worse outcome)

  6. Caregiver stress scores on the UW Caregiver Stress Scale [Follow up at one year]

    Higher scores indicate higher symptom levels (worse outcome)

  7. Emotional processing biases on the Facial Expression Recognition Task (FERT) [Follow up at three years]

  8. Emotional processing biases on the Facial Expression Recognition Task (FERT) [Follow up at two years]

  9. Emotional processing biases on the Facial Expression Recognition Task (FERT) [Follow up at one year]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of Oxford
  • Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.

Investigators

  • Principal Investigator: Catherine Harmer, PhD, University of Oxford

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Oxford
ClinicalTrials.gov Identifier:
NCT05140122
Other Study ID Numbers:
  • R76178/RE001
First Posted:
Dec 1, 2021
Last Update Posted:
Dec 1, 2021
Last Verified:
Oct 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 1, 2021