MiNDToolkit Feasibility Study

Study titlePractical Management of Cognitive and Behavioural Impairment in Motor Neurone Disease: MiNDToolkit Feasibility Study
UK Chief InvestigatorProfessor Eneida Mioshi
Research summaryMotor 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, 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 3 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 (e.g. memory, language, attention), behaviour, wellbeing of the people living with MND and their caregivers. Participants will be randomized 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 (e.g. 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 criteriaINCLUSION 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.

- For patients, presence of another major co-morbid psychiatric disorder; any other non-FTD dementia (e.g. Alzheimer’s disease); any other illness that may be causing dementia-like symptoms.
- For patients, previous history of high consumption of alcohol that in the clinician’s opinion is relevant to their disorder.
- For patients, 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 statusActive – recruiting
Contact detailsMND Research team, email: mnd.research@uea.ac.uk
Recruitment group(s)Participant groups:
1. Patients with MND
2. 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 datesActual opening date: 07 July 2019
Recruitment planned end date: 01 June 2021
Funder(s)Motor Neurone Disease Association (MNDA)
SponsorUniversity of East Anglia
Study designRandomised interventional
Intervention (if applicable)Education or Self-Management
Psychological & Behavioural
Complex Intervention
Management of Care
Active Monitoring
Phase (if applicable)Not applicable
Outcome measuresThe outcomes for Objective 1 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 (e.g. families do not like the novel approach; professionals may have concerns about the tools) The feasibility of participant recruitment will be examined. This will including 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 reportsLinks will be provided when papers are published.
Participant Information Sheet