HighCALS intervention development study
Research type
Research Study
Full title
HighCALS 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.
IRAS ID
250732
Contact name
Christopher McDermott
Contact email
Sponsor organisation
Sheffield Teaching Hospitals NHS Foundation Trust
Duration of Study in the UK
1 years, 6 months, 30 days
Research summary
Amyotrophic 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.
REC name
North West - Greater Manchester East Research Ethics Committee
REC reference
18/NW/0638
Date of REC Opinion
27 Sep 2018
REC opinion
Favourable Opinion