Amyotrophic lateral sclerosis (ALS) Nervous System Diseases Motor neuron disease
Conditions
Interventions
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 o
Sponsors
Sheffield Teaching Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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 judgement has indicated suitability of patient to take part 5. Can understand written / verbal English Carer inclusion criteria: 6. People are eligible to take part in this study where they are the main (or one of the main) informal carers for the patient, and can understand written / verbal English HCP inclusion criteria: 7. 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 8. Can understand written / verbal English
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is to develop materials and strategies, including an online portal, for MDT members and pwALS/carers as part of the HighCALS intervention. To achieve this we will first understand the barriers to, and the enablers of, high calorie nutritional interventions in pwALS from the perspectives of healthcare professionals, patients, and carers via interviews and focus groups. This will generate a list of behavioural targets to address in the HighCALS intervention. User testing will be carried out on the final iteration of the HighCALS intervention using semi-structured interviews with pwALS, their carers and healthcare professionals. As an intervention development study, we will conduct multiple iterative cycles whereby we will gather feedback from a small sample of participants, and use this to refine and update the intervention, before repeating the process with another small sample of participants. | — |
Secondary
| Measure | Time frame |
|---|---|
| A secondary outcome is to develop a training session for staff to deliver the HighCALS intervention to participants randomised to the intervention group for the future randomised controlled trial. | — |
Countries
England, United Kingdom
Contacts
Public ContactGemma Hackney
Outcome results
None listed