MiNDToolkit feasibility study

Practical management of cognitive and behavioural impairment in motor neurone disease: MiNDToolkit feasibility study

UK Chief Investigator

Professor Eneida Mioshi

Research summary

Motor neurone disease (MND) is a progressive neurodegenerative disease that affects movement however, recent research has shown that up to 50% of individual's behaviour and/or thinking ability might also be affected, with up to 15% of patients developing associated frontotemporal dementia (FTD). With multiple tools to detect these changes in behaviour and/or thinking, there are no are recommended methods or techniques to manage these changes.

Therefore, through review of current management/intervention research as well as consultations of health professionals, clinical/research experts, caregivers of those living with MND with FTD and also people living with FTD we have developed the MiNDToolkit for management of cognitive and behavioural changes in MND. The toolkit is for both family members and healthcare professionals.

This study aims to test the feasibility of the new MiNDToolkit in caregivers. The MiNDToolkit provides structured clinical reasoning tools for healthcare professionals, and educational tools and techniques of management for caregivers of those people with MND who might have behaviour and/or thinking problems.

This study will include three phases: a screening/pre-intervention assessment visit, MiNDToolkit intervention visits and post-intervention assessment visit. The screening/pre-intervention assessment visit and post-intervention assessment visit will last approximately 60 minutes and participants will be asked to complete interviews and questionnaires assessing psychological status, thinking abilities (eg memory, language, attention), behaviour, wellbeing of the people living with MND and their caregivers.

Participants will be randomised to a MiNDToolkit intervention and usual treatment (control) groups. The MiNDToolkit intervention visits will only be conducted with caregiver participants. Additionally, healthcare professionals administration of the MiNDToolkit intervention will be monitored.

The recruitment target is to enrol 30 people with MND and 30 of their caregivers/study partners who are eligible for the MiNDToolkit intervention.

Feasibility measures (eg eligibility/recruitment rates, attrition rates/reasons for withdrawal, ratings of the helpfulness of the intervention and qualitative feedback from health professionals) will be recorded.

Inclusion / exclusion criteria

Inclusion criteria

  • Patients with a diagnosis of MND with cognitive impairment or behavioural impairment, based on Strong et al. (2017) diagnostic criteria.

  • Patients with a diagnosis of MND-FTD based on Strong et al. (2017) diagnostic criteria.

  • Study partners of participants with MND will be family carers, relatives or live-in professional carers of the patient participant. These study partners will have at least 14 hours of contact with the participant per week and be willing to participate in research activities.

  • Patients with a diagnosis of MND and study partners between the ages of 18 and 85 years old.

Exclusion criteria

  • For patients:

    • Presence of another major co-morbid psychiatric disorder, any other non-FTD dementia (eg Alzheimer's disease), any other illness that may be causing dementia-like symptoms.

    • Previous history of high consumption of alcohol that in the clinician's opinion is relevant to their disorder.

    • Placement in residential care or nursing home. However, if the person with MND moves to a nursing home during the study, they will continue to be part of the study.

  • Absence of study partner willing to participate.

Current status

Active – recruiting



Sussex Community NHS Foundation Trust

Information about study sites

Contact details

MND Research team

Email: mnd.research@uea.ac.uk

Recruitment group(s)

  • Patients with MND

  • Family carers, relatives or live-in professional carers of the patient participant

Recruitment target(s)

The maximum targets are:

  • 30 MND patients

  • 30 study partners (family carers, relatives or live-in professional carers of the patient participant)

  • Total 60 study participants

Key dates

Actual opening date: 7 July 2019

Recruitment planned end date: 1 June 2021


University of East Anglia

Study design

Randomised interventional

Intervention (if applicable)

  • Education or self-management

  • Psychological and behavioural

  • Complex intervention

  • Management of care

  • Active monitoring

Phase (if applicable)

Not applicable

Outcome measures

The outcomes for objective one are feasibility and acceptability. These will be evaluated by:

  • Numbers of potentially eligible patients who meet the inclusion criteria.

  • Number of participants subsequently recruited into the study.

  • Attrition rate, and reason for withdrawal (eg families do not like the novel approach, professionals may have concerns about the tools).

The feasibility of participant recruitment will be examined. This will include examining numbers assessed for eligibility from each recruitment strategy, numbers eligible, and reasons for ineligibility or non-participation. Attrition rates, and time needed to collect data will be recorded throughout the study. How helpful the intervention has been to the patient and family will also be recorded at the post-intervention assessment.

Publications / Results reports

Links will be provided when papers are published.