HighCALS intervention development

Study titleHighCALS intervention development: A qualitative study to develop, refine and assess the acceptability of a complex intervention to increase nutritional intake in people with Amyotrophic Lateral Sclerosis.
UK Chief InvestigatorProfessor Chris McDermott
Research summaryAmyotrophic lateral sclerosis (ALS), also known as motor neurone disease, is a devastating and progressive condition. It affects the nervous system and eventually causes paralysis and death. Research suggests that for those people with ALS that are able to maintain their body weight, there is an increase in survival time.

However, due to the impact that the disease has on swallowing, alongside an increase in energy requirements, it is often difficult for people to eat and drink sufficient meaning that weight loss is inevitable. There is also a lack of guidance around how best we can support people to meet their nutritional needs.

We are undertaking a large programme of research to develop and test a nutritional support framework for people with ALS. This application is for the second phase of this work, which we are calling the ‘intervention development study’.

This study will involve two phases – in phase 1, we will undertake interviews with people with ALS and their carers, and focus groups with ALS healthcare professionals, to find out about their views on what promotes or prevents best nutritional practice in ALS.

In phase 2, we will use the information gathered in phase 1, alongside that from others parts of our programme, including surveys and reviews of the literature, to help us develop and test a nutritional support package for people with ALS. We will interview patients, carers and healthcare professionals to get their opinions on what we have developed, and as we further refine this, they will be given the package to test for themselves.

We will use all of this information to finalise the support package, which we will then test in a randomised controlled trial in the next phase of our work.
Inclusion/exclusion criteriaINCLUSION CRITERIA
Patient inclusion criteria: 1) Aged 18 years or older; 2) Capacity to give informed consent; 3) 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 neurone disease; 4) Clinician has judged it appropriate for participant to be included.

Carer inclusion criteria: People are eligible to take part in this study where they are the main (or one of the main) informal carers for the patient.

Healthcare professional inclusion criteria: Healthcare professionals who provide nutritional support to pwALS, including medics, specialist nurses, dietitians, speech and language therapists, physiotherapists, occupational therapists, healthcare assistants and so on.

Patient exclusion criteria: 1) Co-morbidity that would affect survival or metabolic state (e.g., unstable thyroid disease or diabetes mellitus); 2) BMI > = 35kg/m2.

Carer & healthcare professional exclusion criteria: Not applicable.
Current statusActive – recruiting
LocationsBury St. Edmunds
London (King's College Hospital)
Contact detailsLead site
Daniel Beever, Email: d.a.beever@sheffield.ac.uk
Recruitment group(s)Participant groups:
1. Patients with MND
2. Carers of patients with MND
3. Healthcare professionals who provide nutritional support to patients with MND.
Recruitment target(s)Phase 1a: 30 participants.
Phase 1b: 64 participants.
Phase 2a: 50 participants.
Phase 2b: 30 participants.
Key datesActual opening date: 23 October 2018
Recruitment planned end date: 30 April 2020
Funder(s)NIHR Programme Grants for Applied Research
SponsorSheffield Teaching Hospitals NHS Foundation Trust
Study designTreatment intervention study
Intervention (if applicable)Dietary
Complex Intervention
Management of Care
Active Monitoring
Phase (if applicable)Not applicable
Outcome measuresThe primary objective is to understand the beliefs, enablers and barriers to meeting the calorie requirements of people with ALS (pwALS), and develop a nutritional support framework (HighCALS) that overcomes the barriers and optimises the enablers to meet the estimated calorie requirements of pwALS.
Publications / Results reportsLinks will be provided when papers are published.
Participant Information Sheet