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Trial registered on ANZCTR


Registration number
ACTRN12624000486527
Ethics application status
Approved
Date submitted
20/07/2023
Date registered
19/04/2024
Date last updated
19/04/2024
Date data sharing statement initially provided
19/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
The Keto-eCoach program: supporting dietary treatment for epilepsy.
Scientific title
The Keto-eCoach program: A randomised controlled trial of a multimodality digital health intervention to aid the delivery of ketogenic diet therapy for epilepsy.
Secondary ID [1] 310018 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Epilepsy 330525 0
Condition category
Condition code
Neurological 327377 327377 0 0
Epilepsy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in the intervention arm will commence on the modified ketogenic diet with the addition of enhanced technology modalities for 12 weeks.
The modified ketogenic diet (MKD) is a low carbohydrate, high fat diet based on a macronutrient distribution of 75% of calories from fat, 20% from protein and 5% from carbohydrate. The MKD will be based on the participant’s weight, age and activity levels. Participants will receive individualised dietary advice from a qualified Dietitian at the randomisation visit at Week 0 (Visit 2). Participants will begin to implement the MKD over a period of two week (run-in phase) and then continue of the MKD for a 12-week treatment phase. Participants will have appointments with the dietitian lasting approximately 30-45 minutes, either in-person or by telemedicine at the beginning of the treatment period at Week 2 (Visit 3), Week 4 (Visit 4), Week 6 (Visit 5), Week 10 (Visit 6) and Week 14 (Visit 7),
Participants in the intervention arm will receive all of the following enhanced technology modalities include (1) daily home-based saliva ketone testing using the MX3 Lab device; (2) daily digital seizure and food diaries, underpinned by (3) dynamic dietitian follow-up, this means the dietitian will have access to the participant's digital diaries and will be able to provide tailored nutrition advice during the study visits. During the 12-week intervention period, participants will be asked test their saliva using the MX3 Lab device. This takes less than 60 seconds daily to complete. Participants will be asked to complete daily electronic food and seizure diaries. The food diaries are summary of daily energy, carbohydrate, protein, fat and fibre intake. Each seizure event will recorded indicating the time and type of event, e.g. focal aware seizure or generalized tonic-clonic seizure, and documentation any anti-seizure rescue medication used. It is estimated these diaries will take between 5-10 minutes per day to complete.
Following the completion of the 12-week treatment period, participants will be followed up every 12 weeks until week 50.
Intervention code [1] 326437 0
Treatment: Other
Comparator / control treatment
Ketogenic diet provided as per standard practice. This includes in-person or telehealth appointments with the Dietitian. Participants will be asked to maintain paper-based diaries, recording daily urine ketone levels, seizure-frequency and dietary intake.
Follow up with the dietitian will be at the same frequency as the intervention arm.
Control group
Active

Outcomes
Primary outcome [1] 335239 0
The primary outcome will be based on a desirability of outcome rank (DOOR). The DOOR is a composite outcome which incorporates change in seizure frequency based on seizure diaries, adverse events based on an adverse event diary and change in quality of life, assessed using the Quality of Life in Epilepsy Inventory-31 (QOLIE-31)
Timepoint [1] 335239 0
12 weeks post commencement of the intervention.
Secondary outcome [1] 423612 0
Proportion of participants with greater than or equal to 50% reduction in seizure frequency per 28-days assessed using seizure diaries after 12 weeks dietary therapy will be compared between groups.
Timepoint [1] 423612 0
At 12 weeks, 24 weeks and 48 weeks post commencement of the intervention.
Secondary outcome [2] 423613 0
Proportion of participants remaining on dietary therapy, assessed using the participant's food diaries, after 12 weeks of treatment will be compared between groups.
Timepoint [2] 423613 0
At 12 weeks, 24 weeks and 48 weeks post commencement of the intervention.
Secondary outcome [3] 423614 0
The number of treatment-related adverse events as recorded by the participants in their study diary will be compared between groups after 12 weeks of treatment.
Timepoint [3] 423614 0
At 12 weeks, 24 weeks and 48 weeks post commencement of the intervention.
Secondary outcome [4] 423615 0
The proportion of participants experiencing a clinically meaningful improvement in quality of life scores using the Quality of Life in Epilepsy Inventory-31 will be compared between groups after 12 weeks of treatment.
Timepoint [4] 423615 0
At 12 weeks, 24 weeks and 48 weeks post commencement of the intervention.
Secondary outcome [5] 423616 0
Change in the number of regular medications use will be compared between groups after 12 weeks of treatment assessed using the participant's study diary and data from the pharmaceutical benefits scheme.
Timepoint [5] 423616 0
12 weeks post commencement of the intervention.
Secondary outcome [6] 423617 0
Total healthcare costs, including direct and indirect healthcare costs will be compared between groups after 12 weeks of treatment. Healthcare costs will be determined using data from data linkage with the Pharmaceutical Benefits Scheme and Medicare Benefits Schedule.
Timepoint [6] 423617 0
At 12 weeks, 24 weeks and 48 weeks post commencement of the intervention.
Secondary outcome [7] 423618 0
Acceptability of the intervention will be compared between the groups using the Theoretical Framework of Acceptability questionnaire.
Timepoint [7] 423618 0
At 12 weeks post commencement of the intervention.
Secondary outcome [8] 430709 0
Proportion of participants with 100% reduction in seizure frequency per 28-days after 12 weeks dietary therapy will be compared between groups.
Timepoint [8] 430709 0
At 12 weeks, 24 weeks and 48 weeks post commencement of the intervention.
Secondary outcome [9] 430724 0
Changes in work productivity using the Work Productivity and Activity Impairment Questionnaire will be compared between the groups.
Timepoint [9] 430724 0
At 12 weeks, 24 weeks and 48 weeks post commencement of the intervention.
Secondary outcome [10] 430725 0
Instances of rescue medication use using the participant's study diaries, will compared between the groups
Timepoint [10] 430725 0
At 12 weeks, 24 weeks and 48 weeks post commencement of the intervention.

Eligibility
Key inclusion criteria
1. Male or female, aged 18 years and over, and less than 60 years.
2. Diagnosis of drug-resistant epilepsy according to ILAE definition, “failure of adequate trials of two tolerated and appropriately chosen and used anti-seizure medication schedules (whether as monotherapies or in combination) to achieve sustained seizure freedom”.
3. Must be under the care of a neurologist for their epilepsy treatment.
4. Experiencing 2 or more seizures per 28-days during the 4-week baseline screening phase.
5. Not currently on ketogenic diet therapy.
6. No changes made to concomitant anti-seizure medications, or neuromodulation settings in the prior four weeks to enrolment.
7. Access to a smartphone, tablet and/or computer and internet access.
8. Has a Medicare card.
9. Is living in Australia.
10. Proficient in speaking and reading English.
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Contraindications to the modified ketogenic diet for epilepsy, including fatty acid and/or amino acid oxidation or transport disorders.
2. Current or previous diagnosis of an eating disorder
3. Pregnancy or breast-feeding
4. Diagnosis of diabetes mellitus, serious hepatic or renal disease, or cancer.
5. Current substance abuse disorder that may affect treatment adherence or response
6. Psychogenic non-epileptic (functional) seizures within the past 12 months.
7. Elevated fasting serum total cholesterol, LDL cholesterol and/or triglyceride levels at baseline, defined as >10% above the reference range. Participants will be excluded if baseline serum total cholesterol is >6.1mmol/L, LDL cholesterol is >2.2mmol/L and/or triglycerides is >2.2mmol/L.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The primary study endpoint will be the odds that a random participant who received dietary therapy with the addition of the enhanced technology intervention will have a more desirable DOOR scale outcome than a random participant who received dietary therapy as per standard care at 12 weeks from the start of the intervention. Such an odds is referred to as the Win Ratio, as it reflects the odds of a random participant receiving the enhanced technology intervention “winning” against a random participant in the standard care arm in a direct one-to-one comparison. A greater frequency of “winners” in the treatment group (Win Ratio statistically significantly greater than 1) will demonstrate the superiority of the enhanced technology intervention. The granularity of the co-designed 60 category DOOR scale minimises the chances of a tied outcome between two randomly chosen patients. If ties were to be observed, they will be split equally between the two groups to reflect the existing clinical equipoise. Primary and secondary endpoint analysis will be conducted on intention-to-treat basis and per-protocol analysis.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
136
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 25039 0
The Alfred - Melbourne
Recruitment postcode(s) [1] 40698 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 314195 0
University
Name [1] 314195 0
Monash University
Country [1] 314195 0
Australia
Primary sponsor type
Hospital
Name
Alfred Health
Address
55 Commercial Road, Melbourne, Victoria 3004
Country
Australia
Secondary sponsor category [1] 316273 0
None
Name [1] 316273 0
Address [1] 316273 0
Country [1] 316273 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313322 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 313322 0
Ethics committee country [1] 313322 0
Australia
Date submitted for ethics approval [1] 313322 0
22/11/2023
Approval date [1] 313322 0
06/02/2024
Ethics approval number [1] 313322 0

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

Contacts
Principal investigator
Name 127730 0
Dr Neha Kaul
Address 127730 0
Alfred Health, 55 Commercial Road, Melbourne, VIC 3004
Country 127730 0
Australia
Phone 127730 0
+61 390763063
Fax 127730 0
Email 127730 0
n.kaul@alfred.org.au
Contact person for public queries
Name 127731 0
Neha Kaul
Address 127731 0
Alfred Health, 55 Commercial Road, Melbourne 3004
Country 127731 0
Australia
Phone 127731 0
+61 390763063
Fax 127731 0
Email 127731 0
n.kaul@alfred.org.au
Contact person for scientific queries
Name 127732 0
Neha Kaul
Address 127732 0
Alfred Health, 55 Commercial Road, Melbourne 3004
Country 127732 0
Australia
Phone 127732 0
+61 390763063
Fax 127732 0
Email 127732 0
n.kaul@alfred.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.