OptiCALS RCT

OptiCALS RCT

UK Chief Investigator

Professor Christopher McDermott

Research summary

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.

Current status

Active – recruiting

Recruitment groups

Participant groups:

1. Patients with MND

2. Family members of patients with MND (including pre-symptomatic gene carriers)

3. Healthcare professionals

Recruitment targets

• 304 patients with MND

• 30 healthcare professionals

• (No specific recruitment target for family members)

Click here to see how many participants have been recruited into this study to date (external link to the NIHR public study search) 

Locations

• Dorothy House Hospice, Wiltshire (Principal Investigator: Edward Presswood)

• Dundee (Principal Investigator: Ian Morrison)

• Liverpool (Principal Investigator: Carolyn Young)

• Middlesbrough (Principal Investigator: Anthony Hanratty)

• Oxford (Principal Investigator: Martin Turner)

• Plymouth (Principal Investigator: Oliver Hanemann)

• Sheffield (Principal Investigator: Chris McDermott)

• King's College Hospital, London (Principal Investigator: Ammar Al-Chalabi)

• Stoke (Principal Investigator: Tom Lambert)

• Salford (Principal Investigator: Christina Federico)

• LOROS hospice, Leicestershire (Principal Investigator: Christina Faull)

• Hounslow and Richmond Community NHS Trust (Principal Investigator: Andrea Foreroozer)

• Swansea (Principal Investigator: Idris Baker)

• Preston (Principal Investigator: Suresh Chettri)

• York (Principal Investigator: Sarah Baker) Site in set-up, opening soon

• Dublin (Principal Investigator: Orla Hardiman) Site in set-up, opening soon

• University College London (Principal Investigator: Richard Orrell) Site in set-up, opening soon

Information about study sites

Key dates

Recruitment open date: 10 August 2021

Planned recruitment end date: 31 December 2023

Inclusion / exclusion criteria

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 two years of onset of first muscle weakness.

• Stabilised on riluzole for one month or not on riluzole.

Exclusion criteria

• Co-morbidity that would affect survival or metabolic state (eg 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).

Funder

National Institute for Health Research (NIHR)

Sponsor

The University of Sheffield

Phase

4