Anxiety Clinical Trial
Official title:
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
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.
Status | Not yet recruiting |
Enrollment | 72 |
Est. completion date | September 30, 2026 |
Est. primary completion date | September 30, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - Inability to provide informed consent for any reason. |
Country | Name | City | State |
---|---|---|---|
Canada | Montreal Children's Hospital | Montréal | Quebec |
Canada | Research Institute of the McGill University Health Centre | Montréal | Quebec |
Lead Sponsor | Collaborator |
---|---|
McGill University Health Centre/Research Institute of the McGill University Health Centre | The Scientific and Technological Research Council of Turkey |
Canada,
Aaberg KM, Gunnes N, Bakken IJ, Lund Soraas C, Berntsen A, Magnus P, Lossius MI, Stoltenberg C, Chin R, Suren P. Incidence and Prevalence of Childhood Epilepsy: A Nationwide Cohort Study. Pediatrics. 2017 May;139(5):e20163908. doi: 10.1542/peds.2016-3908. — View Citation
Austin J, Dunn D, Huster G, Rose D. Development of scales to measure psychosocial care needs of children with seizures and their parents. 1. J Neurosci Nurs. 1998 Jun;30(3):155-60. doi: 10.1097/01376517-199806000-00002. — View Citation
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Sayik D, Acikgoz A, Yimenicioglu S. A randomized controlled study: Evaluating the efficacy of a mobile application developed for mothers who have children with epilepsy in Turkiye. J Pediatr Nurs. 2023 May-Jun;70:103-110. doi: 10.1016/j.pedn.2023.02.010. — View Citation
Turan Gurhopur FD, Isler Dalgic A. The effect of a modular education program for children with epilepsy and their parents on disease management. Epilepsy Behav. 2018 Jan;78:210-218. doi: 10.1016/j.yebeh.2017.07.048. Epub 2017 Dec 6. — View Citation
Wohlrab GC, Rinnert S, Bettendorf U, Fischbach H, Heinen G, Klein P, Kluger G, Jacob K, Rahn D, Winter R, Pfafflin M; Famoses Project Group. famoses: a modular educational program for children with epilepsy and their parents. Epilepsy Behav. 2007 Feb;10(1 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in epilepsy knowledge after 1 month of use of the Mobile Epilepsy Education Package | 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. | 7 weeks | |
Secondary | Change in epilepsy anxiety after 1 month of use of the Mobile Epilepsy Education | This will be assessed with the "Parental Anxiety Scale for Seizures." This scale consists of 9 items in 5-point Likert type. Each item in the scale is scored between 1 and 5. A score between 9 and 45 can be obtained from the scale. A high total score indicates that parents have low anxiety about seizures. | 7 weeks |
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