Condition category
Nervous System Diseases
Date applied
19/02/2020
Date assigned
27/02/2020
Last edited
27/02/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Amyotrophic lateral sclerosis (ALS), also known as motor neuron disease (MND), is a devastating neurodegenerative disorder. People with ALS (pwALS) experience a progressive weakness of limb muscles, as well as loss of speech, chewing and swallowing, and eventually succumb to the consequences of respiratory failure due to respiratory muscle weakness. There is no cure for ALS. Malnutrition and weight loss are well recognised poor prognostic factors in ALS. In pwALS with weight loss of 5% or more there is a two-fold increase in risk of death, compared to those who have lost less than 5% of their usual weight at diagnosis. Current guidelines are not evidence-based and do not include any guidance on nutritional management. Surveys indicate a lack of knowledge in healthcare professions regarding the nutritional management of ALS. The poor evidence base explains the poor nutritional outcomes observed. There is a need to confirm the potential of a high calorie diet to influence the disease course in ALS. This study will aim to understand the barriers and enablers of high calorie nutritional interventions in pwALS and develop a nutritional support package targeting these areas.

Who can participate?
Adults over 18 years, with a 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. Carers and healthcare professionals associated with these patients will also take part.

What does the study involve?
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. Interviews will be undertaken at patient home, care setting or other agreed location. 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.

What are the possible benefits and risks of participating?
There are no major disadvantages, other than the time taken to do the interview. Participants may need to take a break or leave the interview at any time. Discussing the participants experience of ALS may be distressing for them, the research team will signpost participants to appropriate organisations for support if needed. We hope participants will find the process beneficial as an opportunity to reflect on their experiences in relation to nutritional management.

Where is the study run from?
1. Sheffield institute for translational neuroscience (UK)
2. Preston MND Care Centre, Royal Preston Hospital (UK)
3. South Tees Hospitals NHS Foundation Trust (UK)

When is the study starting and how long is it expected to run for?
November 2019 to May 2020

Who is funding the study?
National Institute of Health Research through their Programme Grants for Applied Research (PGfAR) (UK)

Who is the main contact?
Naseeb Ezaydi
n.ezaydi@sheffield.ac.uk

Trial website

https://www.sheffield.ac.uk/scharr/sections/dts/ctru/highcals

Contact information

Type

Public

Primary contact

Miss Naseeb Ezaydi

ORCID ID

Contact details

Sheffield Clinical Trials Research Unit
ScHARR
The University of Sheffield
Innovation Centre
c/o Regent Court
30 Regent Street
Sheffield
S1 4DA
United Kingdom
+44 (0)114 215 9426
n.ezaydi@sheffield.ac.uk

Type

Scientific

Additional contact

Prof Christopher McDermott

ORCID ID

http://orcid.org/0000-0002-1269-9053

Contact details

University of Sheffield
Sheffield Institute for Translational Neuroscience
385a Glossop Road
Sheffield
S10 2HQ
United Kingdom
+44 (0)1142 222295
c.j.mcdermott@sheffield.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

CPMS 39652, IRAS 250732

Study information

Scientific 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

Acronym

HighCALS

Study hypothesis

The proposed research described in this protocol forms part of wider programme of work (HighCALS) that seeks to develop and evaluate an intervention to help people living with ALS to achieve a high calorie diet through nutrition behaviours such food fortification and the use of oral nutritional supplements. In line with Medical Research Council guidance on development of complex interventions, the researchers are using a person centred approach to intervention development. In this protocol, the researchers describe a series of qualitative studies to increase our understanding of the barriers to, and enablers of, nutritional behaviours and interventions to achieve a high calorie diet in ALS from the perspectives of patients, carers and healthcare professionals (Phase 1). On the basis of this information (as well as from systematic reviews) the researchers will develop materials (e.g., advice, tips, guidelines) to be delivered via an online portal that will be used as part of the HighCALS intervention. These materials will then be tested for acceptability and usability through further qualitative studies with patients, carers and healthcare professionals (Phase 2).

Ethics approval

Approved 08/10/2018, North West - Greater Manchester East Research Ethics Committee (Health Research Authority, Ground Floor, Skipton House, 80 London Road, London, SE1 6LH, HRA.Queries@nhs.net, 020 797 22545 ), ref: 18/NW/0638

Study design

Qualitative

Primary study design

Observational

Secondary study design

Qualitative research

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Amyotrophic lateral sclerosis (ALS)

Intervention

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. Interviews will be undertaken at patient home, care setting or other agreed location. 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. The nutriotional support package will involve materials (accessible via the online portal and in paper format, if required) designed to help participants meet their calorie requirements, delivered in the form of a personalised strategy. Materials will be informed by behaviour change techniques - for example, information highlighting the link around weight loss and poor outcomes.

Eligible participants will be approached and consented into the study. Participants will attend a study visit, in which they will be introduced to the nutritional support package and how it works. They will then test the package at home over a period of 4 weeks. As the package is accessible via a website, the research team will be able to see how they have interacted with the support package over the 4 weeks, e.g. mouse clicks on certain pages of the website. After 4 weeks, participants will be invited to take part in a face to face interview with a member of the research team. This will last up to an hour and take place either in the participant's home or care setting. The interview will involve discussing their experience of using the support package. This will mark the end of their participation in the study.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

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 outcome measures

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.

Overall trial start date

02/04/2018

Overall trial end date

02/05/2020

Reason abandoned (if study stopped)

Eligibility

Participant 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

Participant type

Mixed

Age group

Adult

Gender

Both

Target number of participants

30

Participant 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

Recruitment start date

18/11/2019

Recruitment end date

25/05/2020

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Sheffield Institute for Translational Neuroscience
N Floor, Room N127 Royal Hallamshire Hospital Glossop Road Sheffield S10 2JF
Sheffield
S10 2JF
United Kingdom

Trial participating centre

Preston MND Care Centre, Royal Preston Hospital
Preston MND Care Centre Preston Hospital, Ward 17, Sharoe Green Lane Fulwood Preston PR2 9HT
Preston
PR2 9HT
United Kingdom

Trial participating centre

South Tees Hospitals NHS Foundation Trust
South Tees Hospitals Middlesbrough TS4 3BW
Middlesbrough
TS4 3BW
United Kingdom

Sponsor information

Organisation

Sheffield Teaching Hospitals NHS Foundation Trust

Sponsor details

Royal Hallamshire Hospital
Glossop Rd
Broomhall
Sheffield
S10 2JF
United Kingdom
+44 (0)114 271 1900
alessia.dunn@nhs.net

Sponsor type

Hospital/treatment centre

Website

http://www.sth.nhs.uk/

Funders

Funder type

Government

Funder name

National Institute of Health Research through their Programme Grants for Applied Research (PGfAR)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

This study will provide important information on the views of patients, carers and healthcare professionals on (i) the barriers/enablers to achieving a high calorie diet in people living with ALS and (ii) intervention materials to support a high calorie diet.

Planned outputs will be published in the ALS Journal / neurology journals, MNDA website, dietetic and/or behavioural medicine journals. They will increase the awareness of healthcare professionals, patients and carers of the benefits of managing the nutritional intake of patients with ALS. Reports distilling the findings will be sent to NHS commissioners, policy makers and NICE.
A Communication and Dissemination Plan has been created detailing the planned outputs for the research study. This is a working document that will be updated as the grant progresses.

IPD sharing statement:
The current data sharing plans for this study are unknown and will be available at a later date.

Intention to publish date

02/03/2024

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

24/02/2020: Trial’s existence confirmed by National Institute for Health Research (NIHR).