Clinical trial NCT06402526: Evaluating the Efficacy of a Mobile Epilepsy Education Application
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Epilepsy
Epilepsy in Children
Anxiety
Knowledge, Attitudes, Practice
Keywords: Epilepsy
Mobile application
Education
Anxiety
Knowledge
Parents/Caregivers
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
Collaborators: name: The Scientific and Technological Research Council of Turkey
First posted: 2024-05-07
Enrollment: 72
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Eligible participants will be randomly allocated in a 1:1 ratio to the intervention group (use of MEEP) or the control group (standard care).
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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

1. To determine whether MEEP used by parents/caregivers of children with epilepsy reduces their anxiety about epilepsy.
2. To determine whether there is an increase in adherence to treatment by using the following MEEP features:

   1. "treatment/exam control time reminder" tab in the "follow-up section" of MEEP; and
   2. data on app usage (number of logins, time spent on app).

Primary and Secondary Endpoints/Outcome Measures The primary outcome is epilepsy knowledge and will be assessed using the " Epilepsy Knowledge Scale for Parents." The secondary outcome is parental anxiety and will be assessed with the "Parental Anxiety Scale for Seizures."

Other secondary outcomes are:

1. To determine whether there is an increase in adherence to treatment by using the "treatment/exam control time reminder" tab in the "follow-up section" of MEEP.
2. To determine whether there is an increase in adherence to treatment by using the data on app usage (number of logins, time spent on app).

Eligibility criteria: 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.

Primary outcomes:
measure: Change in epilepsy knowledge after 1 month of use of the Mobile Epilepsy Education Package
timeFrame: 7 weeks
Secondary outcomes:
measure: Change in epilepsy anxiety after 1 month of use of the Mobile Epilepsy Education
timeFrame: 7 weeks
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Montreal Children's Hospital
state: Quebec
city: Montréal
country: Canada
facility: Research Institute of the McGill University Health Centre
state: Quebec
Study officials:
affiliation: RI-MUHC, Montreal Children's Hospital, McGill University
name: Kenneth Alexis Myers, MD PhD FRCPC
role: PRINCIPAL_INVESTIGATOR
affiliation: Ingram School of Nursing, McGill University
name: Dilek Sayik, RN, PhD
role: STUDY_CHAIR
affiliation: Faculty of Health Sciences, Eskisehir Osmangazi University
name: Ayfer Acikgoz, RN, PhD
role: STUDY_CHAIR
affiliation: Shriners Hospitals for Children, Ingram School of Nursing, McGill University
name: Argerie Tsimicalis, RN, PhD
role: STUDY_CHAIR
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