|Study title||Development and pilot testing of a web-based decision aid for people with motor neurone disease considering a gastrostomy: DiAMoND Study|
|UK Chief Investigator||Dr Sally Wheelwright|
|Research summary||More 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. One way of managing this is to have a feeding tube fitted into the stomach, known as a percutaneous endoscopic gastrostomy (PEG) or a radiologically inserted gastrostomy (RIG). Food, drink and medicines can be delivered directly into the body through the tube.
Although this seems a good solution, there is very little evidence to back this assumption. It is not clear whether tube feeding 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 feeding tube fitted or what it’s like to live with one and may decide it is not the right choice for them.
The aim of this project it to develop a web-based decision aid (DA) to help people with MND decide whether to have a gastrostomy. A DA presents accurate and reliable information, clearly explains the risks and benefits of with each possible choice and checks understanding. DAs also help people understand what is most important to them, helping them to make decisions which fit their values.
This project will follow international guidelines for developing a DA. We will look at previous research and resources that are already available. Crucially, we will interview people with MND, carers and healthcare professionals to make sure we include the right information and present it in the best way possible. As the DA will be web-based, the final version can be shared widely, ensuring that it reaches the people and organisations who need it most.
|Inclusion/exclusion criteria||INCLUSION CRITERIA
Patients: Individuals with a confirmed diagnosis of motor neurone disease (MND) with a life expectancy of at least a year
OR Carers, defined as ‘Any adult who looks after a family member, partner or friend with motor neurone disease. The care they give 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
AND Able to communicate, either verbally or using other means e.g. using a communication aid, at phrase or sentence level.
• Unable to participate in English
• < 18 years
• Individuals assessed as lacking capacity
• Carers of individuals assessed as lacking capacity.
|Current status||Active – recruiting|
|Recruitment group(s)||Participant groups:
1. Patients with MND
2. Carers of patients with MND
3. Healthcare professionals.
|Recruitment target(s)||Over phase 1 and 2 of the study we plan to recruit a total of 40 patients, 25 carers and 25 healthcare professionals.|
|Key dates||Actual opening date: 01 June 2019
Recruitment planned end date: 14 December 2021
|Funder(s)||Marie Curie and the Motor Neurone Disease Association
|Sponsor||University of Southampton|
|Study design||Cohort observational|
|Intervention (if applicable)||Not applicable|
|Phase (if applicable)||Not applicable|
|Outcome measures||The overall aim of the study is to develop and pilot a web-based decision aid (DA) to support individuals with motor neurone disease (MND) choose whether to have a gastrostomy feeding tube.
The objectives of the study are to:
1. Gather and systematically collate evidence from existing literature
2. Develop a web-based patient decision aid for individuals with MND following International Patient Decision Aid Standards (IPDAS) and in collaboration with individuals with MND, their carers and clinicians, to support decision-making about gastrostomy feeding tube placement
3. Pilot test the design and acceptability of the DA with individuals with MND, their carers and clinicians.
|Publications / Results reports||Links will be provided when papers are published.|
|Participant Information Sheet|