跳至主要内容
临床试验/NCT06402526
NCT06402526已完成不适用

Unicentre Parallel Open Randomized Trial to Evaluate the Efficacy of a Mobile Epilepsy Education Application Developed For The Parents/Caregivers of Children With Epilepsy in Canada

McGill University Health Centre/Research Institute of the McGill University Health Centre4 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2024年6月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
72
试验地点
4
主要终点
Change in epilepsy knowledge after 1 month of use of the Mobile Epilepsy Education Package

研究概览

简要总结

Background. Following a childhood diagnosis of epilepsy, children and their families encounter significant concerns about the disease trajectory, side effects of anti-seizure medications, and long-term prognosis. The multitude of uncertainties can cause significant anxiety in the family, often within the context of limited supports and resources. Epilepsy education can help address these concerns, mitigating the development of anxiety, ultimately leading to better patient-, family- and system-level outcomes. Globally, the MEEP is the only mobile application providing education, monitoring of symptoms, and tracking of medical appointments. The original MEEP was developed, tested, and integrated into practice in Turkey; the investigators will now evaluate the efficacy of an English and French version of the MEEP for families of children with epilepsy in Canada.

A two-group, single-center, randomized controlled intervention trial with 1:1 allocation ratio will be conducted in the Pediatric Neurology Clinic of the Montreal Children's Hospital. Seventy-two caregivers of children with epilepsy (intervention=36, control= 36), aged 1-17 years and treated at the study site will be eligible. Family Introduction Form, Epilepsy Information Scale for Parents and Parental Anxiety Scale for Seizures will be used to collect data at baseline and 3 weeks post-delivery of the 7-week intervention. The MEEP consists of 2 parts. The first part entails the delivery of the educational content of the MEEP, and the second part consists of a "Parental Monitoring Section." Comparator. The control group will continue to benefit from the standard educational services provided by the study site.

详细描述

OBJECTIVES:

Evaluate the efficacy of an English and French version of the Mobile Epilepsy Education Package (MEEP) for parents/caregivers of children with epilepsy in Canada.

Primary Objective:

To determine whether the MEEP used by parents/caregivers with children diagnosed with epilepsy increases the level of knowledge about epilepsy.

Secondary Objectives

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Parents/caregivers whose children are between 1-17 years old;
  • Parents/caregivers whose child was diagnosed with epilepsy at least 2 months ago;
  • At least one primary caregiver is comfortable interacting in English or French; and
  • At least one primary caregiver owns and uses a smartphone on a daily basis.

排除标准

  • - Inability to provide informed consent for any reason.

结局指标

主要结局

Change in epilepsy knowledge after 1 month of use of the Mobile Epilepsy Education Package

时间窗: 7 weeks

This will be assessed using the "Epilepsy Knowledge Scale for Parents." This scale consists of 20 questions including the cause of seizures, emergency care, complications of seizures, cognitive and psychosocial consequences and limitations. In scoring the items in the scale, False means "0" and True means "1". A score between 0-20 can be obtained from the scale. A high total score indicates that parents have a high level of knowledge about epilepsy.

次要结局

  • Change in epilepsy anxiety after 1 month of use of the Mobile Epilepsy Education(7 weeks)

研究者

发起方
McGill University Health Centre/Research Institute of the McGill University Health Centre
申办方类型
Other
责任方
Principal Investigator
主要研究者

Kenneth Myers, MD

Principal Investigator

McGill University Health Centre/Research Institute of the McGill University Health Centre

研究点 (4)

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