MiNDToolkit Feasibility Study
Research type
Research Study
Full title
Practical Management of Cognitive and Behavioural Impairment in Motor Neurone Disease: MiNDToolkit Feasibility Study
IRAS ID
260290
Contact name
Eneida Mioshi
Contact email
Sponsor organisation
University of East Anglia
Duration of Study in the UK
2 years, 0 months, 1 days
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, 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.
Lay summary of study results: Evidence on management of behavioural symptoms in MND is lacking. The MiNDToolkit, an online psychoeducational platform, was developed to support carers dealing with behavioural symptoms present in the people with MND (pwMND) they care wfor. The MiNDToolkit feasibility study’s objectives were to ascertain recruitment and retention rates, carer and healthcare professional (HCP) use of the platform, and completion of online assessments, to inform a full-scale trial. Carers of pwMND with behavioural symptoms were recruited through MND services. After confirming eligibility, participants completed screening and baseline assessments online via the MiNDToolkit platform and were randomised to MiNDToolkit intervention or control group. 151 carers from 11 sites were invited to join the study either by letter or face-to-face, of which 30 were screened and 29 were randomised. Of these, 15 carers were allocated to the control arm and 14 to the MiNDToolkit intervention. Regarding carer retention and engagement, study retention was high (82.76%) and carers engaged with the platform on average 14 times during the study period. Based on feedback from qualitative interviews with HCPs, the MiNDToolkit training and platform was reported to be a beneficial and acceptable resource for HCPs with potential to increase knowledge and confidence in identifying and managing behavioral symptoms in MND. Implementation barriers included HCPs’ perceptions that highlighting behavior changes would be burdensome to carers, and assumptions that carers would take the initiative to ask for support from clinicians. Degree of intervention reinforcement varied, with most HCPs delegating intervention delivery solely to the online platform. In summary, the MiNDToolkit study was feasible and well accepted by carers and trained HCPs. The platform was also thought to increase accessibility of support to carers. The flexible approach to delivery (online platform and optional HCP reinforcement) is also acceptable as an intervention for supporting carers of pwMND with behavioral symptoms. However, MiNDToolkit should not negate HCP involvement in providing medical and practical information to pwMND and families. Future research should explore ways to incorporate support for carers in the management of pwMND alongside standard care, alongside tools such as the MiNDToolkit. A definitive trial is warranted.
Summary Results:
https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fclick.pstmrk.it%2F3ts%2Fwww.isrctn.com%252Feditorial%252FretrieveFile%252F88c3f60c-8b3f-4f6f-9209-a321af635777%252F39906%2FNBTI%2FG0K4AQ%2FAQ%2F6ce75daa-d874-4424-a741-fcec781455ba%2F3%2F_CEJ5lvOx5&data=05%7C02%7Cqueensquare.rec%40hra.nhs.uk%7C91143046e1434ff66dbc08dcdd75e66b%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638628745644348030%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=lAeCbgOTZEJmUek87NeQq7IOVN2M8lTRLaqCkys4WEg%3D&reserved=0REC name
London - Queen Square Research Ethics Committee
REC reference
19/LO/0692
Date of REC Opinion
8 May 2019
REC opinion
Favourable Opinion