Telehealth in Motor Neurone Disease: a single-centre, randomised controlled feasibility and pilot study of the use of the TiM telehealth system to deliver highly specialised care in Motor Neurone Disease, at a distance

ISRCTN	ISRCTN26675465
DOI	https://doi.org/10.1186/ISRCTN26675465
ClinicalTrials.gov number	NCT02464748
Secondary identifying numbers	17022

Submission date: 05/09/2014
Registration date: 05/09/2014
Last edited: 22/10/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nervous System Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
Care of patients with motor neurone disease (MND)/amyotrophic lateral sclerosis (ALS) is best provided by a specialist multidisciplinary team, but access to this care is not universal. Technology-enabled care has the potential to improve access to specialist care in MND. The aim of this study is to test a telehealth system (TiM: Telehealth in Motor neurone disease) which was developed to allow patients and carers to share information about their condition using the internet with a specialist MND nurse. The patients and carers use an app which asks a series of questions about their condition and wellbeing which are automatically sent to the MND nurse.

Who can participate?
Patients aged 18 or over MND and their primary informal carers

What does the study involve?
Patients and their carers are randomly allocated to receive either usual MND care or usual care plus the use of the TiM system for a minimum of 6 months and maximum of 18 months. The first aim is to test the study methods and determine whether a larger study of the TiM is possible. The second aim of the study is to better understand the processes occurring when the TiM is in use in clinical care, whether it is acceptable to patients, carers and healthcare professionals, what works, for whom and how it could be used in the wider NHS. The study collects clinical outcomes (such as quality of life) using postal questionnaires and interviews with participants and clinicians are conducted to assess the feasibility of the study and the TiM system.

What are the possible benefits and risks of participating?
The potential benefits of taking part include better access to specialist MND care. There are few foreseeable risks, and the TiM system has been designed in collaboration with patients to ensure it can be used by those with disabilities.

Where is the study run from?
Sheffield Institute for Translational Neuroscience (UK)

When is the study starting and how long is it expected to run for?
September 2014 to March 2016

Who is funding the study?
1. Motor Neurone Disease Association (MNDA) (UK)
2. National Institute for Health Research (UK)

Who is the main contact?
Dr Esther Hobson
e.hobson@sheffield.ac.uk

Contact information

Dr Esther Hobson
Scientific

Sheffield Institute for Translational Neuroscience
B12, 385A Glossop Road
Sheffield
S10 2HQ
United Kingdom

ORCID ID	0000-0002-8497-2338
Email	e.hobson@sheffield.ac.uk

Study information

Study design	Randomised; Interventional; Design type: Diagnosis, Process of Care, Treatment
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Home
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	Telehealth in Motor Neurone Disease: a single-centre, randomised controlled feasibility and pilot study of the use of the TiM telehealth system to deliver highly specialised care in Motor Neurone Disease, at a distance
Study acronym	Telehealth in Motor Neurone Disease
Study objectives	Motor neurone disease is a rare but debilitating neurological condition that causes paralysis of the bodys muscles leading to severe disability and eventually death. Patients often struggle to travel the long distances to specialist clinics to receive the care they require whilst this expert care is often unavailable in the community. Telehealth has the potential to enable a specialist team to monitor the health and wellbeing of patients and their carers whilst they are at home. This could improve the patient's health, improve the quality of life of both patients and their carers, and lead to more effective use of health resources. This is a pilot study. It aims to determine the feasibility and acceptability of the telehealth system to patients, carers and their health care providers. It also aims to determine how a larger trial could successfully evaluate the clinical and cost-effectiveness of the system.
Ethics approval(s)	Yorkshire & The Humber - Bradford Leeds Research Ethics Committee, 15/07/2014, REC ref: 14/YH/1068
Health condition(s) or problem(s) studied	Topic: Dementias and neurodegeneration; Subtopic: Motor neurone disease; Disease: Motor neurone disease
Intervention	This is a randomised controlled pilot study that will involve 40 patients who are cared for by the Sheffield Motor Neurone Disease care centre and their main informal carer. Half of the participants will use the telehealth system for a minimum of 6 months and maximum of 18 months and information will be collected from patients, carers and their care team. This will include collecting clinical outcome measures, health resource use and the opinions and experience of using the system. All participants will continue to receive their usual care. The TiM telehealth system is a system through which patients and their carers can enter data about their condition on a weekly basis. Their answers are automatically analysed and are available to their MND team. The team are automatically alerted to a change in their condition. The system involves using an Android app on a tablet computer. This relays data via 3G mobile signal to the internet and stored on a server after analysis. The tablet computer also provides education and feedback. Follow Up Length: 18 month(s)
Intervention type	Supplement
Primary outcome measure	Feasibility and acceptability; Timepoint(s): End of the trial
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/09/2014
Completion date	01/03/2016

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	Planned Sample Size: 80; UK Sample Size: 80
Total final enrolment	77
Key inclusion criteria	1. Patients aged 18 years or over with ElEscorial clinically definite or clinically probable categories of MND who have attended the MND clinic at the Royal Hallamshire Hospital, Sheffield 2. Live within 120 minute drive from Sheffield
Key exclusion criteria	The main circumstances where patients or carers will be excluded are those in which individuals would be unable to use the telehealth system or give informed consent. 1. Patients attend another MND care centre in the UK. 2. Significant impairment in decision making capacity preventing informed consent by the subject due to a major mental disorder including frontotemporal dementia. 3. Patient unable to use the system due to physical, intellectual or language difficulties and unwilling to permit carer to operate it on their behalf 4. The patient has no eligible informal carer willing to participate in the trial 5. No available mobile or landline telephone or 3G mobile phone reception at the patients home (this is required to use the TiM system) 6. Any other major impairment that may affect their ability to participate in the study
Date of first enrolment	01/09/2014
Date of final enrolment	01/03/2016

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Sheffield Institute for Translational Neuroscience

Sheffield
S10 2HQ
United Kingdom

Sponsor information

Sheffield Teaching Hospitals NHS Trust (UK)
Hospital/treatment centre

Research Department
11 Broomfield Road
Sheffield
S10 2SE
England
United Kingdom

"ROR"	https://ror.org/018hjpz25

Funders

Funder type

Charity

Motor Neurone Disease Association (MNDA) (UK)
Private sector organisation / Associations and societies (private and public)

Alternative name(s): MND Association, MNDA
Location: United Kingdom

National Institute for Health Research (UK); Grant Codes: Research contract
Government organisation / National government

Alternative name(s): National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
Location: United Kingdom

Results and Publications

Intention to publish date	31/12/2018
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	Planned publication in a high-impact peer reviewed journal in 2018.
IPD sharing plan	The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Esther Hobson (e.hobson@sheffield.ac.uk). Data will be available after publication in 2018/2019 (depending on data). Access criteria: to those with an analysis protocol agreed by University of Sheffield and host institution. Analysis type: quantitative and secondary qualitative analysis. Type of data: anonymised patient and carer reported outcomes, TiM usage data, anonymised semi-structured interview transcripts. Ethical restrictions: interview transcripts will require anonymisation at source.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	22/10/2019	22/10/2020	Yes	No
HRA research summary			26/07/2023	No	No

Editorial Notes

22/10/2020: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added from the reference.
07/06/2019: No publications found. Verifying results with principal investigator.
15/05/2018: Plain English summary, publication and dissemination plan, and IPD sharing statement added.
14/05/2018: No publications found, verifying study status with principal investigator.