DiAMOND (phase 3)

DiAMoND study phase 3: Feasibility testing of a web-based decision aid for people with motor neurone disease considering a gastrostomy

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.

Find out more or take part in the study at gastrostomychoice.co.uk

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?' was developed to help people with MND decide whether to have a gastrostomy. 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 MND who are deciding whether to have a gastrostomy tube or about to start this process.

  • Carers, defined as: 'any individual >18 years, who looks after a family member, partner or friend with MND 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 three times a week.' Currently or within the last year.

  • Healthcare professionals working with individuals with MND, involved in the gastrostomy decision-making process or supporting patients through this (CCT).

  • Must have access to the internet and be able to complete online forms and questionnaires (or has someone who is able to support them to complete these).

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 status

Open to recruitment

Locations

  • Marie 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)

Information about study sites

Contact details

Email: diamond@soton.ac.uk

Recruitment group(s)

Recruiting patients, carers and HCP participants – can self-refer in on the study site: 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 five focus groups with up to eight participants)

Key dates

Actual opening date: 30 July 2021

Planned recruitment end date: 30 June 2022

Sponsor

University of Southampton

Study design

Observational

Intervention (if applicable)

Not applicable

Phase (if applicable)

Not applicable

Outcome measures

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.