Trial ID: ISRCTN30588041
Other - Phase Unknown - No longer available
Background and study aims Amyotrophic lateral sclerosis, or ALS, is a progressive nervous system disease that affects nerve cells in the brain and spinal cord, causing loss of muscle control. ALS is often called Lou Gehrig's disease, after the baseball player who was diagnosed with it. 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 effective manner. The intervention package includes 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. 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. Who can participate? Patients diagnosed with Amyotrophic Lateral Sclerosis/Motor neuron disease, within 2.5 years onset of first muscle weakness. Their carers can also participate in qualitative interviews. What does the study involve? Participants will be randomly assigned to the control group or the intervention group. The control group will continue to receive their usual care, and be restricted to only completing food diaries on the OptiCALS web portal. They will have subsequent study visits during months 1, 3, 6, 9 and 12 to review their food diaries. During these visits, the participant will have measurements and tests taken. The intervention group will be shown OptiCALS during their first study visit. Participants will use OptiCALS for 12 months. They will be asked to complete three food diaries before each study visit during months 1, 3, 6, 9 and 12. These visits will be planned around clinic visits or will be planned separately. At each visit, the participant will have measurements and tests taken. We will also interview 20 participants and their carers to discuss their thoughts on using OptiCALS. Each interview will last an hour and take place in the participant's home or care setting. These interviews will take place 1-3 months after joining the study and then again at 6-12 months. What are the possible benefits and risks of participating? None Where is the study run from? 1. Sponsor - Sheffield Teaching Hospitals NHS Foundation Trust (UK) 2. The University of Sheffield Clinical Trial Research Unit (day-to-day delegated management) When is the study starting and how long is it expected to run for? April 2020 to April 2027 Who is funding the study? National Institute for Health (NIHR) Programme Grant for Applied Research (PGfAR) (UK) Who is the main contact? Elaine Scott, Gemma Hackney, OptiCALS@sheffield.ac.uk
Sheffield Teaching Hospitals NHS Foundation Trust
Source: https://www.isrctn.com/