|Study title||DiAMoND Study Phase 3: Feasibility testing of a web-based decision aid for people with motor neurone disease considering a gastrostomy|
|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. 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 criteria||INCLUSION 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).
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 status||Open to Recruitment|
|Locations||University Hospitals Coventry and Warwickshire NHS Trust
Marie Curie West Midlands Hospice, Solihull (in setup)
Derriford Hospital, Plymouth
Royal Devon and Exeter Hospital (Wonford) (in setup)
Royal Preston Hospital
Royal Stoke University Hospital
Russells Hall Hospital
Salford Royal Hospital
Salisbury District Hospital
Southampton General Hospital
St George’s Hospital (Tooting), London (in setup)
|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:
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 dates||Actual opening date: 30 July 2021
Recruitment planned end date: 31 December 2021
|Funder(s)||Marie Curie and the Motor Neurone Disease Association
|Sponsor||University of Southampton|
|Intervention (if applicable)||Not applicable|
|Phase (if applicable)||Not applicable|
|Outcome measures||The 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 reports||Links will be provided when papers are published.|
|Participant Information Sheet|