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 |
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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
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
Scientific
Sheffield Institute for Translational Neuroscience
B12, 385A Glossop Road
Sheffield
S10 2HQ
United Kingdom
0000-0002-8497-2338 | |
e.hobson@sheffield.ac.uk |
Study information
Study design | Randomised; Interventional; Design type: Diagnosis, Process of Care, Treatment |
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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 |
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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
S10 2HQ
United Kingdom
Sponsor information
Hospital/treatment centre
Research Department
11 Broomfield Road
Sheffield
S10 2SE
England
United Kingdom
https://ror.org/018hjpz25 |
Funders
Funder type
Charity
Private sector organisation / Associations and societies (private and public)
- Alternative name(s)
- MND Association, MNDA
- Location
- United Kingdom
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 |
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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? |
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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.