A randomized controlled trial of a multimodality digital health intervention to aid the delivery of the modified ketogenic diet therapy for epilepsy: The Ketotrial protocol
Source: PubMed Central Open Access, NCBI / U.S. National Library of Medicine
Abstract Objective Dietary therapy is an effective treatment for drug‐resistant epilepsy; however, low adherence presents a significant barrier to use in the clinical setting. This study aims to evaluate a multimodality digital health intervention to overcome this barrier and improve outcomes in adults undertaking the modified ketogenic diet for epilepsy. epi470345-sec-0001 Method This is a two‐arm, randomized, controlled trial. A total of 136 participants will be randomized 1:1 to receive the modified ketogenic diet as per standard clinical care, or with the addition of the multimodality digital health intervention for 12 weeks. The intervention will include three components: (1) digital diaries, (2) a novel, at‐home, saliva‐based ketone testing device, and (3) dynamic dietitian support. epi470345-sec-0002 Results The primary treatment benefit will be determined using the epilepsy desirability of outcome rank, a composite outcome measure co‐designed with people living with drug‐resistant epilepsy. Secondary outcomes will include seizure frequency, treatment retention, adverse events, psychiatric symptoms, quality of life, medication use, cost effectiveness, and acceptability of the intervention. epi470345-sec-0003 Significance The results of this trial will provide evidence on the effectiveness of using this innovative digital health intervention approach to improve treatment outcomes of dietary therapy for drug‐resistant epilepsy. epi470345-sec-0004 Ethics and Dissemination
Abstract
Abstract Objective Dietary therapy is an effective treatment for drug‐resistant epilepsy; however, low adherence presents a significant barrier to use in the clinical setting. This study aims to evaluate a multimodality digital health intervention to overcome this barrier and improve outcomes in adults undertaking the modified ketogenic diet for epilepsy. epi470345-sec-0001 Method This is a two‐arm, randomized, controlled trial. A total of 136 participants will be randomized 1:1 to receive the modified ketogenic diet as per standard clinical care, or with the addition of the multimodality digital health intervention for 12 weeks. The intervention will include three components: (1) digital diaries, (2) a novel, at‐home, saliva‐based ketone testing device, and (3) dynamic dietitian support. epi470345-sec-0002 Results The primary treatment benefit will be determined using the epilepsy desirability of outcome rank, a composite outcome measure co‐designed with people living with drug‐resistant epilepsy. Secondary outcomes will include seizure frequency, treatment retention, adverse events, psychiatric symptoms, quality of life, medication use, cost effectiveness, and acceptability of the intervention. epi470345-sec-0003 Significance The results of this trial will provide evidence on the effectiveness of using this innovative digital health intervention approach to improve treatment outcomes of dietary therapy for drug‐resistant epilepsy. epi470345-sec-0004 Ethics and Dissemination This study has received approval from the Alfred Hospital Human Research Ethics Committee (Reference No.: 723/23). The results will be disseminated via peer‐reviewed publications and publicly available plain language summaries. epi470345-sec-0005 Trial Registration Number Australian New Zealand Clinical Trials Registry (ANZCTR, ACTRN12624000486527). epi470345-sec-0006 Plain Language Summary This trial aims to find out if a 12‐week digital health program can improve treatment outcomes of people living with epilepsy. We will invite 136 people commencing on the modified ketogenic diet to be randomly assigned to the digital health program or standard clinic care. The treatment outcome will be assessed combining seizure frequency, side effects, and quality of life. epi470345-sec-0007