DiAMoND Study: Phase 3 V1.0
Research type
Research Study
Full title
DiAMoND Study Phase 3: Feasibility testing of a web-based decision aid for people with motor neurone disease considering a gastrostomy
IRAS ID
295473
Contact name
Sally Wheelwright
Contact email
Sponsor organisation
University of Southampton
Duration of Study in the UK
0 years, 7 months, 29 days
Research summary
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.
Summary of Results
• Who carried out the research? (including details of sponsor, funding and any competing interests)
This study was sponsored by the University of Southampton and funded jointly by Marie Curie and Motor Neurone Disease Association.
There were no competing interests
• What public involvement there was in the study (how many people, what their relevant lived experience was, and what they did)
The idea of developing a decision aid for people with motor neurone disease (MND) considering a gastrostomy was initially presented to an MND support group for feedback and to invite members to join the research team. The group were supportive of the project which led to the initial application.
People affected by MND participated by commenting on all patient and carer facing documents.
• Where and when the study took place
The study was UK wide and took place between May 2021 and June 2022.
• Why was the research needed?
MND is a life limiting neurodegenerative disease with no known cure. Many people with MND develop problems swallowing, making eating and drinking difficult. For this reason, people with MND are often offered a gastrostomy tube (a thin plastic tube which goes through a small opening in your belly directly into your stomach) to provide nutrition, fluids and medication. Ethical challenges to research mean the evidence to show whether having a gastrostomy tube fitted is beneficial is limited. As a result, the decision to have a gastrostomy tube fitted is not straight forward for people with MND and their carers.
Patient decision aids help individuals to make decisions by providing evidence-based information, outlining the risks and benefits associated with each option, checking understanding and clarifying personal values.
• What were the main questions studied?
The study aimed to assess whether Gastrostomy tube – Is it for me? (web-based patient decision aid) is acceptable, practical and beneficial for patients with MND, their carers and the healthcare professionals working with them.Who participated in the study?
• Individuals with MND
• Healthcare professionals working with individuals with MND and involved in the decision on gastrostomyWhat happened during the study?
Participants were invited to use the decision aid and then answer some feedback questions. Healthcare professionals took part in focus groupsWhat were the results of the study?
Seventeen patients completed the questionnaires after using the decision aid. Patients found the decision aid acceptable and would recommend it to other people in their position. All participants were satisfied with their decision making. Healthcare professional provided positive feedback during the focus groups and provided suggestions for how the decision aid could be used in clinical practice.How has this study helped patients and researchers?
The decision aid, Gastrotomy Tube: Is it for me? is the first UK decision aid to support people living with MND in gastrostomy tube decision making. Feedback on the decision aid by people living with MND shows they found it acceptable, practical and useful. The DA is hosted by the MND Association and is freely available (https://eur03.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.gastrostomychoice.co.uk%2F&data=05%7C01%7Capprovals%40hra.nhs.uk%7Ce6e6cecf0db64997671508daf93f9698%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638096348746357248%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=1l2XJSQhCuTsatgAVTmGR1fCf%2B4frt%2FUSlufsax4apE%3D&reserved=0).Details of any further research planned
No further research is planned at the moment.Where can I learn more about this study?
The decision aid can be found on the Motor Neurone Disease Association Website:https://eur03.safelinks.protection.outlook.com/?url=https%3A%2F%2Fu2790089.ct.sendgrid.net%2Fls%2Fclick%3Fupn%3DXv3JSvJ-2B3M71ppf7N9agbVkxajViMqEi3mzBVX2CGSexbMZH1Ef9mG5e-2F6xRyTS5ksRpC2WQc6KTczRzFoU5ExI5TWRzMQtYNb4IafTMH0mLEyRTvIs-2BoZ3T-2FWwLX9nQkDHKnEmvf-2BzPbYOQ-2BU7KrVXclzlWu29MV9tdrF2z3OzP8HvTo-2Ft1xBNsBYAo1T2N6Z0Uzr2FjOtV9C0cpb-2FzfdRtzLIgsE0HLjVqpEhQnZlwuMhKgMZ1y8wVeU7-2FT0VwgSvD_E1aO2-2BZlVOSJJV-2FajQqskegTd6IRomHYTi-2Fbt8SH3YIyhwHpGNmSwtThvn2riAVS-2BCSFv-2FW253GxAJrZejb9Cve6kbgKVTvjKh6iG-2FzgbWI5-2Brv-2F6b-2Fteylz4hfKOD4OmFWQV-2BKSls6Rlrs6OS7qcW5NX9QNqyPHeuzzTnWaw4egT9q2ZRMHJQ71LXybPCNyILhfw80PtLMDLgsuJYXnr9ci0F1ITM-2B-2FutVv9P4ITa4-3D&data=05%7C01%7Capprovals%40hra.nhs.uk%7Ce6e6cecf0db64997671508daf93f9698%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638096348746357248%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=Rl14DH6z4Sosj7qP3yGSsTB3c%2BophRTjMOkuBBa1Flo%3D&reserved=0
REC name
London - Surrey Borders Research Ethics Committee
REC reference
21/PR/0571
Date of REC Opinion
17 May 2021
REC opinion
Favourable Opinion