DiAMoND (phase 3)

Testing of the ‘Gastrostomy tube – Is it for me?’ decision aid within clinical practice – assessing whether it is acceptable, practical, and beneficial for people with MND, carers and healthcare professionals

This study is actively recruiting people living with MND, carers and healthcare professionals, and the study is completed ‘remotely’.

What does taking part involve?

After providing consent within the decision aid, participants will be asked to provide some information about themselves, and complete the feedback questionnaire(s).

Healthcare professional participants will also be invited to take part in a focus group to explore how to effectively disseminate and integrate the decision aid into clinical practice.

The participant information sheet, available to view in the decision aid, provides further information.

Study location

This study is being conducted by the University of Southampton. Participants can be UK-wide (remote).  To find out more or take part in the study please click here

 

Study titleDiAMoND Study Phase 3: Feasibility testing of a web-based decision aid for people with motor neurone disease considering a gastrostomy
UK Chief InvestigatorDr Sally Wheelwright
Research summaryMore than 80% of individuals with motor neurone disease (MND) develop problems with swallowing. This can make it harder to eat and drink, with the potential to cause significant distress, choking risk, chest infections and weight loss. As well as this, factors such as laboured breathing, and loss of hand function resulting in an inability to feed oneself, often impact upon nutritional intake. For this reason, gastrostomy tubes are offered to people with MND as a way to meet nutrition and hydration needs, and to receive medications. Although this seems a good solution, there is very little evidence to back this assumption. It is not clear whether having a gastrostomy tube improves nutrition in people with MND, whether it makes them live longer or even if it improves their quality of life. Some people have concerns about having a gastrostomy tube fitted or what it’s like to live with one and may decide it is not the right choice for them. In phase 1 and 2 of the DiAMoND study a web-based decision aid (DA) 'Gastrostomy tube - Is it for me?' to help people with MND decide whether to have a gastrostomy was developed. The aim of this study is to test whether the decision aid is acceptable, practical and beneficial for people with MND, their carers and the healthcare professionals working with them. The study will also explore how to disseminate and implement the DA in clinical practice. People living with MND, their carers, and healthcare professionals working with them will be invited to provide feedback through online questionnaires. Focus groups with health professionals will be held to explore how to disseminate and integrate the DA into clinical practice.
Inclusion/exclusion criteriaINCLUSION CRITERIA

Individuals with a confirmed diagnosis of motor neurone disease (MND) who are deciding whether to have a gastrostomy tube or about to start this process OR Carers, defined as: ‘any individual > 18 years, who looks after a family member, partner or friend with motor neurone disease who is considering gastrostomy placement. The care they provide is unpaid, and they have face-to-face contact with the person with MND at least 3 times a week.’ (currently or within the last year) OR Healthcare professionals working with individuals with MND, involved in the gastrostomy decision-making process or supporting patients through this (CCT) AND Have access to the internet and able to complete online forms and questionnaires (or has someone who is able to support them to complete this).

EXCLUSION CRITERIA

Unable to participate in English < 18 years Individuals assessed by their healthcare team as lacking capacity Carers of individuals assessed by their healthcare team as lacking capacity Carers who lack capacity.
Current statusOpen to Recruitment
LocationsMarie Curie West Midlands Hospice, Solihull
Moorgreen Hospital
Derriford Hospital, Plymouth
Royal Devon and Exeter Hospital (Wonford)
Russells Hall Hospital
Salford Royal Hospital
Salisbury District Hospital
St George’s Hospital (Tooting), London (not recruiting at present)
Contact detailsdiamond@soton.ac.uk
Recruitment group(s)Recruiting patients, carers and HCP participants – can self-refer in on study site (link below).

Study site: https://www.gastrostomychoice.co.uk/

Recruitment target(s)We plan to recruit across the three participant groups as follows:
Patients: 100
Carers: minimum of 50 (maximum of 100)
Healthcare professionals: minimum of 20 (maximum of 40: up to 5 focus groups with up to 8 participants).
Key datesActual opening date: 30 July 2021
Planned recruitment end date: 30 June 2022
Funder(s)Marie Curie and the Motor Neurone Disease Association

SponsorUniversity of Southampton
Study designObservational
Intervention (if applicable)Not applicable
Phase (if applicable)Not applicable
Outcome measuresThe aim of the study is to assess whether the ‘Gastrostomy tube – Is it for me?’ decision aid is acceptable, practical, and beneficial for people with MND, their carers and the healthcare professionals working with them.

The objectives of the study are to:

1. Explore the acceptability and practicality of Gastrostomy tube – Is it for me? for people living with MND, their carers and healthcare professionals
2. Assess whether Gastrostomy tube – Is it for me? is beneficial to people living with MND deciding whether to have a gastrostomy
3. Understand the best way to disseminate and implement Gastrostomy tube – Is it for me? into clinical practice across the UK
Publications / Results reportsLinks will be provided when papers are published.
Participant Information Sheet