Practical management of behavioural impairment in motor neurone disease: MiNDToolkit feasibility study
| ISRCTN | ISRCTN15746123 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15746123 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 260290 |
| Protocol serial number | IRAS 260290, CPMS 41888, Grant Codes: Mioshi/May16/934-794 |
| Sponsor | University of East Anglia |
| Funder | Motor Neurone Disease Association |
- Submission date
- 17/05/2021
- Registration date
- 26/05/2021
- Last edited
- 25/09/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Plain English summary of protocol
Background and study aims
Motor neurone disease (MND) is an uncommon condition that affects the brain and nerves. It causes weakness that gets worse over time.
MND is now recognised as a multi-system disorder, affecting also people's behaviours and cognitive abilities - referred to as 'non-motor symptoms'. This usually occurs in up to 50% of people diagnosed with MND. Clinical assessments have been developed to support identification of these non-motor symptoms, but appropriate support to manage these symptoms are lacking.
This study aims to test the feasibility (can this be done?) of a new psychoeducational intervention for carers, delivered via a bespoke online platform, with optional support from healthcare professionals.
Who can participate?
Carers of people with Motor Neurone disease - family carer/relative/live-in professional carer, who present with additional behavioural impairments.
What does the study involve?
Carers (participants) complete online screening assessments to verify they are eligible to the study. Next, carers complete baseline assessments, also online. Once these assessments are complete, carers are randomly assigned to the MiNDToolkit intervention or control group.
Carers in the intervention group will access the online intervention for 3 months. Healthcare professionals involved in the care of their person with MND may also support the intervention delivery. At the end of the 3-month period, carers complete a follow-up assessment, similar to the baseline assessment. They are then offered to continue using the MiNDToolkit for another 3 months, if they wish to.
Carers in the control group will not access the intervention for the initial 3 months. After this period, carers complete a follow-up assessment, similar to the baseline assessment. They are then offered to start using the MiNDToolkit for 3 months, if they wish to.
What are the possible benefits and risks of participating?
Benefits include access to novel tailored resources for the management of behavioural symptoms, which are currently not available for carers in the UK or other countries.
Risks include distress from completing questionnaires about carers' own health and the person with MND.
Where is the study run from?
University of East Anglia (UK)
When is the study starting and how long it is expected to run for?
July 2020 to March 2023
Who is funding the study?
The Motor Neurone Disease Association (UK)
Who is the main contact?
Prof. Eneida Mioshi, e.mioshi@uea.ac.uk
Contact information
Scientific
University Of East Anglia
School of Health Sciences
Norwich Research Park, Earlham Road
Norwich
NR4 7TJ
United Kingdom
 ORCID ID |
0000-0002-0066-868X |
|---|---|
| Phone | +44 (0)1603 593300 |
| e.mioshi@uea.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Interventional pilot open-label randomized controlled design feasibility study |
| Secondary study design | Randomised cross over trial |
| Study type | Participant information sheet |
| Scientific title | Practical management of behavioural impairment in Motor Neurone Disease: MiNDToolkit for carers feasibility study |
| Study acronym | MiNDToolkit |
| Study objectives | Carers of people with Motor Neurone Disease presenting with behavioural symptoms require additional support to manage these non-motor symptoms. A novel online psychoeducational intervention, the MiNDToolkit, may be useful in supporting carers dealing with these non-motor symptoms. |
| Ethics approval(s) | Approved 05/05/2021, London Queen Square Research Ethics Committee (HRA NRES Centre Bristol, 3rd floor, block B, Whitefriars, Lewins Mead, Bristol, BS1 2NT, UK; +44(0)207 104 8061; queensquare.rec@hra.nhs.uk), ref: 19/LO/0692 |
| Health condition(s) or problem(s) studied | Motor neurone disease with behavioural symptoms |
| Intervention | The new online intervention comprises modules that: (1) target symptoms identified in the screening/baseline assessments; (2) suggest which strategies the person with MND and carer would benefit from; (3) utilise these techniques during each week. In addition, (4) if the HCP of the person with MND has also been trained, they will demonstrate those techniques for the carers during consultations. Each week, the carer will be given modules with information on behavioural symptoms as well as strategies to apply, tailored to the issues identified during the screening/baseline assessments. It is expected that the carer will apply these techniques in their daily routine after the modules for a week. At any following MND consultation with a HCP trained in the MiNDToolkit, a review of strategies utilised will be recorded and the HCP will discuss with the carer what may have worked or not, and examples of context. The healthcare professionals will then record this information on the MiNDToolkit online platform. The intervention period is 3 months. Participants in the control group will be offered the opportunity to use the MiNDToolkit after the follow-up assessment. Participants in the intervention group will be offered the opportunity to continue using the MiNDToolkit for an additional three months, after the follow-up assessment. Randomisation: When a consented participant has completed the screening and pre-intervention assessment, the trial manager will receive an automatic email notification that a participant is ready for randomisation. They will contact (by email or phone) the CTU data management team which holds a randomisation list generated by the study statistician and held on secure CTU servers. Randomisation is simple 1:1 randomisation to either intervention or control arm with no stratification or minimisation. The next allocation on the randomisation list will be communicated to the trial manager who will log this on the platform. The platform sends a text and/or email notification to the participant informing them of their allocation and the next steps in the study processes, e.g. access to the online modules if in the intervention arm or the next follow up survey in the control arm. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
Feasibility of the MiNDToolkit online intervention in MND Specialist Settings measured using: |
| Key secondary outcome measure(s) |
Current secondary outcome measures as of 26/11/2021: |
| Completion date | 30/03/2023 |
Eligibility
| Participant type(s) | Carer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 20 |
| Total final enrolment | 55 |
| Key inclusion criteria | Participants will be family carers, relatives, or live-in professional carers of: 1. Patients with a diagnosis of MND with cognitive impairment or behavioural impairment, based on Strong et al. (2017) diagnostic criteria, or 2. Patients with a diagnosis of MND-FTD based on Strong et al. (2017) diagnostic criteria; 3. Carers will have at least 14 hours of contact with the person with MND per week and be willing to participate in research activities. Carers must be aged 18 years or over |
| Key exclusion criteria | Inability to read or communicate in English (with or without support) |
| Date of first enrolment | 01/07/2021 |
| Date of final enrolment | 16/12/2022 |
Locations
Countries of recruitment
- United Kingdom
- England
- Wales
Study participating centres
Research Office, Ground Floor
Earlham Road
Norwich
NR2 4BX
United Kingdom
Brighton
BN2 3EW
United Kingdom
Sheffield
S10 2JF
United Kingdom
Huddersfield
HD3 3EA
United Kingdom
Leicester
LE3 9QE
United Kingdom
Penarth
CF64 3YR
United Kingdom
Dafen
Llanelli
SA14 8QF
United Kingdom
Cwmrhydyceirw
Swansea
SA6 6NL
United Kingdom
Bury St. Edmunds
IP33 2QZ
United Kingdom
Ipswich
IP4 5PD
United Kingdom
Colney
Norwich
NR4 7UY
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available as this is a feasibility study, which does not aim to evaluate the efficacy of the intervention. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 15/05/2024 | 25/09/2024 | Yes | No | |
| Results article | Process evaluation | 15/05/2024 | 25/09/2024 | Yes | No |
| Basic results | 25/09/2024 | No | No | ||
| HRA research summary | 28/06/2023 | No | No | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Protocol file | version 9 | 06/02/2023 | 06/07/2023 | No | No |
| Statistical Analysis Plan | version 1.0 | 06/07/2023 | No | No | |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Additional files
- ISRCTN15746123_PROTOCOL_V9_06Feb23.pdf
- Protocol file
- ISRCTN15746123_SAP_V1.0.pdf
- Statistical Analysis Plan
- ISRCTN15746123 MiNDToolkit-Basic Results.pdf
- Basic results
Editorial Notes
25/09/2024: Publication references added and the basic results have been uploaded as an additional file.
26/03/2024: The intention to publish date was changed from 31/03/2024 to 30/04/2024.
10/01/2024: The intention to publish date was changed from 31/01/2024 to 31/03/2024.
06/07/2023: Protocol and statistical analysis plan uploaded. The intention to publish date was changed from 01/12/2023 to 31/01/2024.
15/03/2023: The intention to publish date was changed from 01/08/2023 to 01/12/2023. Total final enrolment added.
02/12/2022: Brighton General Hospital, Royal Hallamshire Hospital, Huddersfield Royal Infirmary, Leicestershire and Rutland Hospice, Marie Curie Hospice Cardiff and the Vale, Prince Philip Hospital, Morriston Hospital, West Suffolk Hospital, Ipswich Hospital and Norfolk & Norwich University Hospital were added as trial participating centres.
28/11/2022: The following changes were made to the trial record:
1. The recruitment end date was changed from 30/11/2022 to 16/12/2022.
2. The overall end date was changed from 30/11/2022 to 30/03/2023.
26/08/2022: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/08/2022 to 30/11/2022.
2. The overall end date was changed from 31/12/2022 to 30/11/2022.
3. The intention to publish date was changed from 01/04/2023 to 01/08/2023.
4. The plain English summary was updated to reflect these changes.
13/06/2022: The following changes have been made:
1. The recruitment end date has been changed from 30/06/2022 to 31/08/2022.
2. The intention to publish date has been changed from 01/11/2022 to 01/04/2023.
26/11/2021: The following changes have been made:
1. The overall trial end date has been changed from 30/06/2022 to 31/12/2022 and the plain English summary has been updated accordingly.
2. The recruitment end date has been changed from 31/12/2021 to 30/06/2022.
3. The secondary outcome measures have been updated.
08/06/2021: The recruitment start date was changed from 10/06/2021 to 01/07/2021.
25/05/2021: Trial's existence confirmed by London Queen Square Research Ethics Committee
