Acceptability and impact of a web-based Lifestyle and sElf management Education Program (LEEP) for people with epilepsy

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12615000694516
• Date of registration: 03/07/2015
• Prospective Registration: Yes
• Primary sponsor: St Vincent's Private Hospital Melbourne
• Public title: Acceptability and impact of a web-based Lifestyle and sElf management Education Program (LEEP) for people with epilepsy
• Scientific title: The effect of a web-based Lifestyle and sElf Management Education Program (LEEP) when compared to treatment as usual on seizure frequency, mood, resilience, self-management and quality of life measures for people with epilepsy.
• Date of first enrolment: 01/07/2016
• Target sample size: 150
• Recruitment status: Not yet recruiting
• URL: https://anzctr.org.au/ACTRN12615000694516.aspx
• Study type: Interventional
• Study design: Purpose: Educational / counselling / training; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;
• Phase: Not Applicable

Countries of recruitment

Australia

Contacts

• Name: A/Prof Karen-leigh Edward

• Name: A/Prof Karen-leigh Edward

Key inclusion & exclusion criteria

Inclusion criteria: Participants will be patients who have a diagnosis of the following types of epilepsy - temporal lobe epilepsy, frontal lobe epilepsy, parietal lobe epilepsy, occipital lobe epilepsy, symptomatic generalized epilepsy, idiopathic (genetic) generalised epilepsy, and reflex epilepsy. Additionally, participants can be of any sex, cultural background, and educational background.
Exclusion criteria: Inability to give informed consent and inability to understand English, other types of brain injury that could impact on the person’s ability to provide informed consent or ability to participate in the study.

Age minimum: 18 Years
Age maximum: No limit
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Public Health - Health promotion/education

Neurological - Epilepsy

Epilepsy;
Epilepsy

Intervention(s)

Lifestyle sElf management Education Program (LEEP) is a mobile device application that has three main foci - factual disease related information, providing information related to managing the psychosocial aspects of epilepsy and increasing accessibility of information and support. The participants will complete four (4) education modules across four (4) weeks (i.e. one module per week). Each module should take participants a total of 30 minutes to complete. Information related to participant's adherence to using the intervention will be reported through the application to the research team. The participants will also be receiving a weekly 'check in' telephone call by study staff to see how they are progressing with the program. Participants are required to complete each module weekly over the four weeks, however will have access to the intervention for a total of 8 weeks in the event that they may need extra time to complete modules.

Primary Outcome(s)

Seizure frequency as assessed by self-report seizure diary.[At baseline, 3 months and 6 months after the intervention commencement.]

Self-management ability assessed by Epilepsy Self-Management Scale (ESMS).[At baseline, 3 months and 6 months after the intervention commencement.]

Health Related Quality of Life as assessed by the Quality of Life in Epilepsy Inventory – QOLIE-31. [At baseline, 3 months and 6 months after the intervention commencement]

Secondary Outcome(s)

Economic impact as assessed by direct comparison to usual care and all cause hospital admissions. Data related to hospital admissions with be extrapolated from participant's medical records.[At 6 months after the intervention commencement.]

Mood will be assessed by the Neurological Disorder Depression Inventory for Epilepsy (NDDI-E). This is a Primary Outcome.[At baseline, 3 months and 6 months after the intervention commencement.]

Resilience as assessed by Connor-Davidson Resilience scale CD-RISC. This is a Primary Outcome.[At baseline, 3 months and 6 months after the intervention commencement]

Acceptability of intervention for people with epilepsy assessed by fidelity data (routine use and adherence to program). The program is delivered to participants in mobile phone application. The application will have reporting properties available to the study team to monitor usage and completion of modules. [At 6 months after the intervention commencement.]

Secondary ID(s)

Nil

Source(s) of Monetary Support

St Vincent's Private Hospital Melbourne

Ethics review

Status: Not approved
Approval date:
Contact:

Australian Catholic University HREC