Telehealth in MND-Research (TIM-R): A Research Database for MND
Conditions: MND (Motor Neurone DIsease)
Sponsor: University of Sheffield

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TiM-R Protocol – V1 – 12-03-24 
 
Telehealth in MND-Research (TIM-R): A research database 
for MND Protocol 
 
 
SHORT STUDY TITLE / ACRONYM 
Telehealth in MND-Research / TIM-R 
 
PROTOCOL VERSION NUMBER AND DATE 
Version 1 – 12 March 2024  
 
RESEARCH REFERENCE NUMBERS 
IRAS Number: 
340577 
SPONSORS Number: 
187038 
FUNDERS Reference: 
United2EndMND – Phase 1 
 
 
 

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TiM-R Protocol – V1 – 12-03-24 
 
Contents 
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16. Regulatory issues ................................................................................................................................11 
16.1. Project site ...................................................................................................................................11 
16.2. Clinical Data collection .................................................................................................................11 
16.3 Data linkage ..................................................................................................................................11 
16.4. Investigators’ Responsibilities ......................................................................................................11 
16.5. Project Funding & Oversight ........................................................................................................12 
16.6. Ethics ............................................................................................................................................12 
 
 
 
 

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1. Investigators 
 
Chief Investigator 
Professor Christopher McDermott 
Professor of Translational Neurology and NIHR Professor 
Department of Neuroscience 
University of Sheffield 
Email: c.j.mcdermott@sheffield.ac.uk  
Tel: 0114 222 2295 
Study Coordinator 
Dr Liam Knox, Research Fellow 
l.knox@sheffield.ac.uk  
Sponsor 
University of Sheffield 
 
Funder(s) 
This research is funded by the medical research charity LifeArc.  
Key Protocol Contributors 
Professor Christopher McDermott, Professor of Translational 
Neurology and NIHR Professor 
Email: c.j.mcdermott@sheffield.ac.uk  
Tel: 0114 222 2295 
 
Dr Liam Knox, Research Fellow 
Email: l.knox@sheffield.ac.uk  
 
Dr Esther Hobson, Senior Lecturer & Consultant Neurologist 
Email: e.hobson@sheffield.ac.uk  
 
Dr Alys Griffiths, Senior Research Fellow 
Email: alys.griffiths@sheffield.ac.uk  
 
Dr Yasmin Ali, Research Associate 
Email: yasmin.ali@sheffield.ac.uk 
 
 
 

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2. Protocol Summary 
Title 
Telehealth in MND-Research (TIM-R): A research database 
for MND Protocol 
Acronym 
TIM-R 
Project Aims 
The aim of this study is to implement the Telehealth in MND 
system (TiM) as a research database allowing for people with 
MND (pwMND) to take part in research and provide data 
remotely.  
Project Design 
TiM-R will act as a research database to allow for data 
collection from pwMND. The data will involve questionnaire 
responses relating to MND that will be completed remotely. 
Generic ethical approval will cover a range of prospective 
research regarding remote questionnaires that can be 
completed on TiM-R by pwMND. Researchers will be 
provided with access to anonymised data, dependent on 
approval from a data management committee.  
 
Study Participants 
PwMND.  
Eligibility Criteria 
Inclusion criteria: PwMND using TiM-Care as part of their 
clinical service or pwMND who opt-in to TiM-R. 
Sample Size 
All eligible participants who consent to TiM-R will be 
included. There is no upper restriction on sample size.  
 
Project Duration  
The TiM-R system will be available for pwMND for at least 50 
years. Data collected will be stored and available in an 
anonymised format for researchers indefinitely. 
 
 
3. Abbreviations 
DPUK: Dementia Platform UK 
HCPs: Healthcare Professionals  
MDTs: Multidisciplinary Teams  
MND: Motor Neuron Disease 
pwMND: People with MND 
TiM-C: Telehealth in MND-Care 
TiM-R: Telehealth in MND-Research  
TRE: Trusted Research Environment 
TTP: Trusted Third Party 
 
 

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4. Background 
Motor Neuron Disease (MND) is an incurable disease, causing progressive weakness of 
muscles involving the limbs, speech, and swallowing, leading to progressive disability and 
eventual respiratory failure. In the UK, there are approximately 5,000 people with MND 
(pwMND) at any one time (Opie-Martin et al., 2020). The average life expectancy following 
diagnosis is two to three years but the course of MND can vary from only a few months to 
over ten years. The distress and burden of the disease affects pwMND, their family, and 
carers and the relenting progression of disability causes social, emotional, and financial 
strain (O'Brien et al., 2012; Whitehead et al., 2012). 
In the UK, there are approximately 5,000 people with MND (pwMND) (Opie-Martin et al., 
2020). The average life expectancy following diagnosis is two to three years but the course 
of MND can vary from only a few months to over ten years. The distress and burden of the 
disease affects pwMND, their family, and carers and the relenting progression of disability 
causes social, emotional, and financial strain (O'Brien et al., 2012; Whitehead et al., 2012). 
5. TiM-Care 
To provide more responsive care for pwMND and their carers, the Telehealth in MND-Care 
(TiM-C) on MyPathway system was developed. TiM-C is an online system that enables 
pwMND and their carers to report their symptoms to healthcare professionals (HCPs) from 
their homes using an app or via the online website (Hobson et al., 2018). Users are asked to 
complete symptom questionnaires (e.g., appetite, weight, functional rating, breathing, 
mental health), answers to which are securely sent to the clinical portal (see figure one).  
TiM-C was co-developed with pwMND, carers, and HCPs (Hobson et al., 2019a; Hobson et 
al., 2019b). The system is easy to use, even for those with significant disabilities, acceptable, 
and low in burden, taking approximately five minutes per week to complete. 85% of 
pwMND would recommend TiM to others and 95% would use TiM if they could not travel to 
clinic. HCPs found it accurate and easy to use (Hobson et al., 2019a; Hobson et al., 2019b).  

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TiM-R Protocol – V1 – 12-03-24 
 
FIGURE 1: TIM-CARE AND INTERACTIONS WITH DIFFERENT USER GROUPS. 
6. TiM-Research  
To provide pwMND greater access to research from the comfort of their own homes, and 
collect longitudinal data relating to symptoms and treatment, we have created Telehealth in 
MND-Research (TiM-R). TiM-R will send regular symptom questionnaires to pwMND, whilst 
also enabling invitations to participate in future projects to be sent to those who are 
eligible. Results from research projects can then be sent back to participants (see figure 2). 
Anonymised data from the questionnaires will be made available to researchers in a 
controlled database. 

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TiM-R Protocol – V1 – 12-03-24 
FIGURE 2: TIM-RESEARCH PROVIDING PWMND ACCESS TO RESEARCH. 
 
7. Aim of the project  
The aim of this project is to create a research database that pwMND can be invited to and 
submit regular data (i.e., TiM-R). Users can then be invited to research projects and notified 
of results. Researchers can apply to a Research Management Committee for access to 
anonymised data.   
   
 
 
 
 
 
 
 
 

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8. Project Design  
PwMND will be invited to TiM-R through two methods. 
If they are using TiM-C as part of their clinical care, a notification will appear on their 
account describing the purposes of TiM-R and providing the participant information sheet 
(PIS). They can then provide consent if they are willing to join TiM-R. If the individual does 
not want to join TiM-R, they can still use TiM-C to receive clinical care. 
If the individual is not using TiM-C as part of their clinical care, they may still join TiM-R by 
responding to a study advert, which will describe the purposes of the study and a link to the 
PIS. Advertisements will be distributed through social media, relevant charities (e.g., MND 
Association), and patient support groups. If willing, the participant can follow links on the 
PIS to create their TiM-R account, part of which will include providing consent for the 
purposes of this study.  
Regardless of the invitation method, once the participant has consented, they will have 
access to TiM-R and will start to receive regular research questionnaires (see section 9). 
They may also receive invitations to other research projects for which they are eligible. For 
each of these future projects the user can choose whether to participate.  
The participant can choose to withdraw from TiM-R at any time without having to give a 
reason by contacting the Research Management Committee. Contact details will be 
available through TiM-R. Any withdrawal from TiM-R will not affect participants’ ability to 
use TiM-C. 
Researchers can contact the Research Management Committee to gain access to 
anonymised data collected through TiM-R. The exact process is described in section 12. 
Providing that the reason for this data usage falls under one of the topics covered by this 
generic ethical approval (see section 11), researchers will not require their own NHS ethical 
approval to use this data. If the Research Management Committee agrees access to 
anonymised data, the researcher will be provided with log in details to a Trusted Research 
Environment (TRE), where they can perform analyses and write up necessary reports.  
9. Clinical Data collection 
Once pwMND have created their TiM-R account, they will be asked to complete regular 
questionnaires. These are listed in table 1. Additional questionnaires may occasionally be 
added, either by a researcher request or to update the system in line with literature and 
patient reported outcome measure development. No questionnaire will ask sensitive 
questions relating to protected characteristics. The addition or removal of a questionnaire 
will be dependent on a majority decision of the Research Management Committee, who will 
consider user burden and justification of need for any adaptations. 

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Questionnaire name 
What it measures 
Frequency 
Demographics 
General participant 
information 
Once 
Coping Index-ALS (Young et al., 
2021) 
Coping strategies 
Once every 2 months 
ALSFRS-r (Cedarbaum et al., 
1999) 
Functional rating 
Once every month 
EQ-5D-5L (Herdman et al., 
2011) 
Quality of Life 
Once every 2 months 
Dyspnoea-12 (Yorke et al., 
2011) 
Breathlessness 
Once every 2 months 
M-HADS-D (Gibbons et al., 
2011b) 
Anxiety and depression 
Once every 2 months 
Neurological Fatigue Index-
MND (Gibbons et al., 2011a) 
Fatigue 
Once every 2 months 
WHOQoLB (Group, 1994) 
Quality of life 
Once every 2 months 
MND-Social Withdrawal Scale 
(Gibbons et al., 2013) 
Social withdrawal 
Once every 2 months 
WHODAS (Üstün, 2010) 
Disability  
Once every 2 months 
Rosenberg Self-Esteem Scale 
(Rosenberg, 1965) 
Self-esteem 
Once every 2 months 
General Self-efficacy Scale 
(Schwarzer & Jerusalem, 1995) 
Self-efficacy 
Once every 2 months 
Table 1: TiM-R questionnaire schedule. 
PwMND who also have a TiM-C account complete regular symptom questionnaires. We will 
ask these users to consent to the questionnaires to also be uploaded to the research 
database and used for research purposes, after they have been anonymised. This will be 
included in the PIS. The questionnaires include the SNAQ, PHQ-8, and GAD-7 (Kroenke et al., 
2001; Rolland et al., 2012; Spitzer et al., 2006); however, these may change over the course 
of this project, depending on the needs of clinical teams using TiM-C. 
10. Research Project Overview 
The database will support MND researchers inside and outside of the UK and their 
collaborators. Any outcomes of the research will provide information to improve the care, 
quality of life, and treatment of pwMND. All academic outputs will be publicly available on a 
dedicated website. 
Only staff and researchers who have completed relevant research data security training will 
be granted access to TiM-R. The Research Management Committee will be responsible for 
ensuring that all participant-identifiable data is excluded from available datasets.  

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11.  Areas of research covered by generic ethical approval. 
The areas of research that are covered under this protocol and ethical approval are:  
● MND-related studies that will facilitate and support the development of clinical 
care and advance the knowledge of HCPs and researchers in attempting to find 
new treatments and methods of improving quality of life for pwMND and carers.  
● Studies looking for specific trends or correlations in the data, aiding in 
understanding of the disease progression and investigating potential therapeutic 
benefits or targets for future therapies.  
12.  Access to Data for Research Purposes 
The process for all researchers wishing to request access to data from the clinical database 
for research purposes is: 
● Read the online information regarding what data is available and for what purposes 
it can be used for 
● Use the online application to provide a description of the project, what data is 
requested, and for what purposes 
● The Research Management Committee will respond to the application within 90 
days 
● If approved, the researcher will be asked to accept the terms and conditions of using 
TiM-R data 
● The researcher will then be provided with log in details for the TRE, where they can 
access and analyse the data 
Access may be provided to researchers within universities and commercial companies both 
inside and outside of the UK. We may charge a small fee to researchers for the use of data 
to support the upkeep of TiM research. 
13. Data storage and access 
Data will be stored on Dementia Platform UK (DPUK) Secure eResearch Platform, hosted by 
Swansea University. DPUK acts as an enabling infrastructure, working with data owners to 
facilitate the curation and storage of data and access to that data.  
Cohort data will be housed in its own dedicated area of the UKSeRP 
(https://serp.ac.uk/serp-uk/), readily accessible by cohort permitted persons, and upon 
request and subject to access procedures by the Research Management Committee. This 
system uses two vendor firewalls, two factor authentication for data analysts, weekly 
vulnerability scanning, annual penetration testing, and meets ISO27001 accreditation. All 
data is in File Store. Backups are done via VMBackups and backed up daily. 

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TiM-R Protocol – V1 – 12-03-24 
Upon uploading of data, a dataset will enter into a split-file anonymisation process, to 
reduce the risk of identifying individuals. This process is undertaken with NHS Wales 
Informatics Service (NWIS), a Trusted Third Party (TTP) of Swansea University, who are 
contracted to perform one half of the split-file anonymisation. 
Data held by DPUK will only be made available to researchers who have successfully 
completed the DPUK Study Application process (described in section 12). 
14. Terms and Conditions of Access for Research  
Researchers provided with anonymised data will be required to complete and sign a data 
use agreement to confirm they agree with the terms and conditions of receiving the data. 
These are:  
● Any data provided will not be used for anything other than this research project, 
as described in the Project Summary. 
● If additional uses for the data emerge, the data is required for longer, or the 
project develops such that other data from the database would be of use, a 
request for extension of data use will be submitted and must be approved before 
this additional research takes place.  
● Any data provided will be used appropriately, and as stated in the Application for 
Access to Data.  
● Contribution of data from the TiM-R Database will be acknowledged in the 
authorship of all publications (i.e. papers, presentation at symposia etc.) that 
arise from use of the data.  
● If any issues arise surrounding this agreement, the Research Management 
Committee will be notified as soon as possible.  
15.  Research Management Committee  
Name 
Project Role 
Professor Christopher McDermott (CI) Chief Investigator, Consultant Neurologist 
Dr Esther Hobson  
Consultant Neurologist  
Dr Liam Knox 
Study Coordinator, Research Fellow 
Dr Alys Griffiths 
Senior Research Fellow 
 
Dr Yasmin Ali 
Research Associate 
 

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TiM-R Protocol – V1 – 12-03-24 
The DPUK team 
Technical support 
 
The project will be coordinated and managed by the Research Management Committee. In 
addition to providing overall project coordination, the CI and clinical team will assist in 
ensuring the documentation is maintained and the database is kept up to date, complying 
with relevant ethical and regulatory standards, and that all aspects of the database entry 
and analysis are performed to the highest quality.  
16. Regulatory issues 
16.1. Project site 
All data will be collected from pwMND across the UK. Although this will predominantly be 
users based in the UK, there is the possibility that pwMND outside of the UK create TiM-R 
accounts.   
16.2. Clinical Data collection 
PwMND are responsible for responding to questionnaires on the TiM-R system, therefore 
any data on the database will be directly inputted by participants themselves. TiM-R users 
will be made aware that they do not have to answer any of the questionnaires they are sent 
and can withdraw entirely if they wish. The data is inputted by users at a time and place of 
their choosing.  
Each record holds a database-specific identity number which could then be traced back on 
the database to identify the participant. All data will be anonymised before access is 
provided to researchers. 
16.3 Data linkage 
Participants will be asked to provide broad consent so that data from this project can be 
made available to researchers to answer scientific questions beyond the scope of the 
primary outcomes specified. 
In order to update clinical outcome data and to leverage data collected by other research 
studies and routinely collected datasets, identifiable data will be made available to link the 
TiM-R dataset to other sources such as the ALS Biomarkers study, NHS databases, hospital, 
GP, local authority records, national registries, and other research studies. 
Where data sharing requires identifiable data to be transferred outside of the project 
database the minimum data necessary will be shared to achieve linkage and the data will be 
shared using secure transfer methods. 

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16.4. Investigators’ Responsibilities  
Investigators are responsible for performing the project in accordance with the NHS 
Research Governance, Guidelines for Good Clinical Practice and the Declaration of Helsinki 
guidelines (www.wma.net). Investigators are required to ensure compliance to the protocol. 
Investigators are required to allow access to project documentation or source data on 
request for monitoring visits and audits performed by any regulatory authorities.  
16.5. Project Funding & Oversight  
This research is funded by the medical research charity LifeArc. The University of Sheffield 
will provide project oversight.  
16.6. Ethics  
This research database will conform to the Declaration of Helsinki guidelines 
(http://www.wma.net/) on research involving human subjects. The project protocol will be 
submitted to the NHS Research Ethics Committee for approval before commencing research 
activities.  
17. References  
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C. A. (2011b). Rasch analysis of the Hospital Anxiety and Depression Scale (HADS) for use in motor 
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Gibbons, C. J., Thornton, E. W., Ealing, J., Shaw, P. J., Talbot, K., Tennant, A., & Young, C. A. (2013). Assessing 
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