|Study title||OptiCALS RCT|
|UK Chief Investigator||Prof Christopher McDermott|
|Research summary||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|
|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 2 years of onset of first muscle weakness.
Stabilised on Riluzole for one month or not on Riluzole.
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).
|Current status||Active – recruiting|
|Locations||Dorothy House Hospice, Wiltshire
Ninewells Hospital, Dundee
The Walton Centre for Neurology and Neurosurgery, Liverpool
James Cook Hospital, Middlesborough
John Radcliffe Hospital, Oxford
Derriford Hospital, Plymouth
Royal Hallamshire Hospital, Sheffield
Other sites joining soon - watch this space!
|Recruitment group(s)||Participant groups:
1. Patients with MND
2. Family members of patients with MND (including pre-symptomatic gene carriers)
3. Healthcare Professionals
|Recruitment target(s)||The maximum targets are:
We aim to recruit 304 participants, with 152 participants in the control group and 152 participants in the intervention group. Regarding professionals, we hope to recruit 30, (10 PIs and 20 interventionists). We don't have a concrete target for carer recruitment as a proportion of the patient participants will also have their carer recruited, but this is optional for them. Some will not have carers and some carers may not want to participate. So excluding carers, the total sample size should be 334.
|Key dates||Actual opening date: 10 August 2021
Recruitment planned end date: TBC
|Funder(s)||National Institute of Health Research Central Commissioning Facility
Programme Grants for Applied Research
|Sponsor||University of Sheffield|
|Intervention (if applicable)|
|Phase (if applicable)||Phase 4|
|Publications / Results reports||Links will be provided when papers are published.|
|Participant Information Sheet|