Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000694516
Ethics application status
Not yet submitted
Date submitted
4/06/2015
Date registered
3/07/2015
Date last updated
15/10/2015
Type of registration
Prospectively registered

Titles & IDs
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.
Secondary ID [1] 286860 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Epilepsy 295255 0
Condition category
Condition code
Neurological 295500 295500 0 0
Epilepsy
Public Health 295501 295501 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 292029 0
Treatment: Other
Intervention code [2] 292030 0
Lifestyle
Intervention code [3] 292031 0
Behaviour
Comparator / control treatment
Treatment as usual which includes their contact with their treating specialist neurologist and/or any other healthcare professional on their treatment team.
Control group
Active

Outcomes
Primary outcome [1] 295235 0
Seizure frequency as assessed by self-report seizure diary.
Timepoint [1] 295235 0
At baseline, 3 months and 6 months after the intervention commencement.
Primary outcome [2] 295236 0
Self-management ability assessed by Epilepsy Self-Management Scale (ESMS).
Timepoint [2] 295236 0
At baseline, 3 months and 6 months after the intervention commencement.
Primary outcome [3] 295237 0
Health Related Quality of Life as assessed by the Quality of Life in Epilepsy Inventory – QOLIE-31.
Timepoint [3] 295237 0
At baseline, 3 months and 6 months after the intervention commencement
Secondary outcome [1] 315161 0
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.
Timepoint [1] 315161 0
At 6 months after the intervention commencement.
Secondary outcome [2] 315162 0
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.
Timepoint [2] 315162 0
At 6 months after the intervention commencement.
Secondary outcome [3] 315592 0
Mood will be assessed by the Neurological Disorder Depression Inventory for Epilepsy (NDDI-E). This is a Primary Outcome.
Timepoint [3] 315592 0
At baseline, 3 months and 6 months after the intervention commencement.
Secondary outcome [4] 315594 0
Resilience as assessed by Connor-Davidson Resilience scale CD-RISC. This is a Primary Outcome.
Timepoint [4] 315594 0
At baseline, 3 months and 6 months after the intervention commencement

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be randomly allocated to two groups (Lifestyle Self-Management Education Group (LEEP) vs. control). Once the participant is enrolled, the researcher will then complete baseline questionnaires, and contact the study coordinator who will obtain the randomisation allocation from the trial centre. Data will be entered into a study database. Consenting participants will be randomly assigned to one of the two study groups with 1:1 allocation ratio. Clinical staff enrolling participants will be blind to the allocation. Participants will not be blind to the allocation. The statistician will be blinded for comparison of the data sets.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The study coordinator will obtain the randomisation allocation from the trial centre. Data will be entered into a study database. Consenting participants will be randomly assigned to one of the two study groups with 1:1 allocation ratio. Simple randomisation table will be created using a computerised sequence generator.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Descriptive and exploratory analysis will be undertaken on the data, and the balance of groups at baseline will be checked. The main analysis will comprise a multivariate treatment of the data (multivariate analysis of variance, MANOVA), in which the significance of the intervention on a linear combination of outcome measures will be assessed. If appropriate, baseline scores will be used as a covariate in a multivariate analysis of covariance (MANCOVA) procedure. Blocking factors will be accounted for in the analysis if appropriate. A significant finding from the MANOVA or MANCOVA procedures will be followed-up with univariate ANOVAs to identify the measures that best discriminate between groups. If assumptions of equality of variance-covariance matrices and multivariate normality of the data are not violated, a discriminant function analysis will also be undertaken to aid interpretation of the linear combination of outcomes and to assess the ability of the outcome measures to classify cases. Cross-validation procedures will also be undertaken to assess the portability of the model, including diagnostic procedures to identify any influential data points. Cross-validation procedures will also be undertaken to assess the portability of the model, including diagnostic procedures to identify any influential data points. We wish to recruit sufficient participants to allow us to demonstrate that a proportionate change in the mean rates of seizure between education groups of 50% is statistically significant at a standard level of power (80%), with significance level set at 0.05. This level of variability is of clinical importance requires 63 participants in total (126 in each arm). However, to allow for a 15% attrition loss we aim to recruit a total of 75 participants in each arm of this study (i.e. 150 in total).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2016
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 3880 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment hospital [2] 3881 0
St Vincent's Private Hospital - Fitzroy
Recruitment postcode(s) [1] 9774 0
3065 - Fitzroy

Funding & Sponsors
Funding source category [1] 291416 0
Hospital
Name [1] 291416 0
St Vincent's Private Hospital Melbourne
Country [1] 291416 0
Australia
Primary sponsor type
Hospital
Name
St Vincent's Private Hospital Melbourne
Address
59-61 Victoria Parade
Fitzroy Victoria 3065
Country
Australia
Secondary sponsor category [1] 290092 0
None
Name [1] 290092 0
Address [1] 290092 0
Country [1] 290092 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 292965 0
Australian Catholic University HREC
Ethics committee address [1] 292965 0
Ethics committee country [1] 292965 0
Australia
Date submitted for ethics approval [1] 292965 0
01/04/2016
Approval date [1] 292965 0
Ethics approval number [1] 292965 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 57830 0
A/Prof Karen-leigh Edward
Address 57830 0
St Vincent's Private Hospital Melbourne
Nursing Research Unit
59-61 Victoria Parade Fitzroy Vic 3065
Country 57830 0
Australia
Phone 57830 0
+61 3 94117338
Fax 57830 0
Email 57830 0
[email protected]
Contact person for public queries
Name 57831 0
Karen-leigh Edward
Address 57831 0
St Vincent's Private Hospital Melbourne
Nursing Research Unit
59-61 Victoria Parade Fitzroy Vic 3065
Country 57831 0
Australia
Phone 57831 0
+61 3 94117338
Fax 57831 0
Email 57831 0
[email protected]
Contact person for scientific queries
Name 57832 0
Karen-leigh Edward
Address 57832 0
St Vincent's Private Hospital Melbourne
Nursing Research Unit
59-61 Victoria Parade Fitzroy Vic 3065
Country 57832 0
Australia
Phone 57832 0
+61 3 94117338
Fax 57832 0
Email 57832 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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Documents added automatically
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