OptiCALS: A Randomised Controlled Trial with parallel Process Evaluation and Health Economic analysis to evaluate a nutritional management intervention, OptiCALS, for patients with Amyotrophic Lateral Sclerosis

Study ID: 46436
Short Title: OptiCALS Randomised Controlled Trial
Organisation: Salisbury NHS Foundation Trust
Location: Salisbury District Hospital
Condition: Motor neurone disease
Main Specialty: Neurological disorders
Expected End Date: 31/03/2024
Postcode: SP2 8BJ
Contact Name: R&D department
Contact Email: sft.sftresearch@nhs.net
Active: Yes

Inclusion criteria, exclusion criteria and study summary

Patient Inclusion Criteria: - Age 18 years or older. - Diagnosis of clinically definite, lab supported, clinically probable, or possible ALS by the El-Escorial criteria and additionally the PMA variant where appropriate investigation has excluded mimics of motor neuron disease. - Within 2 years of onset of first muscle weakness. - Stabilised on riluzole for one month or not on riluzole.

Patient Exclusion Criteria: - Co-morbidity that would affect survival or metabolic state (e.g. unstable thyroid disease or unstable diabetes mellitus). - BMI > = 35kg/m2. - Lacking capacity to provide fully informed written consent, verbal consent (for those who cannot provide written consent), or consent via the use of a communication aid. - Previous participation in the HighCALS PGfAR research programme. - Unable to understand written and spoken English. - Using a gastrostomy tube for feeding (those using a gastrostomy tube for fluid or medication are not excluded).

The purpose of this study is to test a support package (the ‘OptiCALS’ intervention) designed to improve nutritional management for people living with amyotrophic lateral sclerosis (ALS), also known as motor neurone disease. Little is currently known regarding how food intake affects ALS and there is a lack of guidance for patients and healthcare professionals on weight and nutrition in ALS. Evidence from small studies suggests better nutrition helps people with ALS live for longer. In light of this, we have designed a web portal called OptiCALS that people with ALS can use. The OptiCALS intervention has been designed to help people with ALS receive the best diet at the most appropriate time, in the most cost-effective manner. The package will include a range of materials including videos, information, advice and interactive tools designed to assist people with ALS to optimise their nutrition. This will be provided alongside support from a healthcare professional. We will test if using OptiCALS helps people with ALS live for longer than those who do not use OptiCALS.

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