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Title:
Adherence to Ketogenic diet therapy for children and young people with epilepsy: how can we do better?
Supervisors:
Prof Rob Horne and Dr Natasha Schoeler
Project Description:
Background
Ketogenic diet therapy (KDT), a group of high-fat, low-carbohydrate diets, are an effective treatment option for children and young people with drug-resistant epilepsy, but around half of children and young people referred for KDT do not start; of those who do start, 25% may discontinue before the 3-month point (Ketogenic Dietitians Research Network, 2019).
There are no standardized instruments or interventions to objectively deal with non-adherence in KDT, despite the fact that adherence is essential for disease management and for evaluating treatment success [1]. To address this need, we are developing a tool-kit to support adherence to KDT as part of the ‘Keto-Start’ study. Keto-Start (funders: NIHR; Rosetrees Trust) seeks to understand the barriers and facilitators to KDT adherence and co-design supportive interventions, applying NICE guidelines for medicines adherence recommendations [CG76]. These guidelines apply the Perceptions and Practicalities Approach (PAPA), a framework for involving patients in treatment decisions and for designing adherence support that is tailored to address the specific perceptions and practicalities, influencing the patient’s motivations and ability to adherence [2].
In our preparative work, we identified key perceptual barriers and practical difficulties that are associated with non-adherence to KDT [3]. These map onto the PAPA framework in a way that is consistent with >93 published studies of medication adherence [4], spanning 27 medical conditions, including epilepsy.
An alternative is also needed to the invasive and, often, inaccurate ketone monitoring and diet histories currently employed to assess adherence to KDT. The ‘iKeto-Check’ questionnaire is a novel alternative method, validated in an Italian population [5].
Aims/Objectives
Aim: To develop and prototype an intervention package to support adherence to KDT in children and young people with epilepsy and their families and to assess its effectiveness in improving KDT starter rates
Objectives:
i) Develop the intervention package, using co-designs from ‘Keto-Start’
ii) Cultural adaptation of ‘iKeto-Check’
iii) Investigate the effectiveness of the intervention package on diet initiation rates in a ‘before and after’ study using the adapted ‘iKeto-check’
Methods
Intervention designs from Keto-Start will be co-developed and the ‘iKeto-Check’ questionnaire adapted for use in the UK, alongside a family-professional advisory group. Agreement rate and content validity index will be calculated and factorial analysis performed to test internal consistency. The intervention package will be prototyped in 4 NHS ketogenic services over 4months.
Stakeholders will be interviewed during and after the intervention to reflect on the feasibility and sustainability of the intervention; the intervention package will be refined accordingly.
The effectiveness of the intervention package on KDT starter rates will be assessed with a ‘before and after’ study with a waitlist control design in 10 NHS ketogenic services. The reasons for not starting diet will be explored via semi-structured interview. For those who start diet, adherence will be assessed with use of ‘iKeto-Check’.
Timeline
Year 1: Intervention development and adaptation of ‘iKeto-Check’
Year 2: Prototyping period (Q1) and intervention refinement (Q2)
Year 3: ‘Before and after’ study
References
1. doi: 10.1016/j.nutres.2024.03.009
2. doi: 10.1027/1016-9040/a000353
3. doi: 10.1016/j.yebeh.2014.07.020
4. doi: 10.1016/j.pec.2015.11.004
5. doi: 10.3390/foods12173214
Contact Information:
Natasha Schoeler