Motor Neuron DiseaseTiMNCT02464748
Telehealth in Motor Neurone Disease
A study testing TiM telehealth arm in people with Motor Neuron Disease, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Motor neurone disease (MND) is a rare but debilitating neurological condition that causes paralysis of the body's 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Motor Neuron Disease
- What is being tested?
- TiM telehealth arm
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2014to Apr 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Patient Inclusion Criteria:
- Patients aged 18 years or over who have attended the MND clinic at the Royal Hallamshire Hospital, Sheffield.
- Patients with amyotrophic lateral sclerosis diagnosed by a consultant neurologist with symptom onset within the last three years.
- Or
- Patients with amyotrophic lateral sclerosis, primary muscular atrophy or progressive lateral sclerosis diagnosed by a consultant neurologist with a deterioration in their condition as evidenced by a deterioration in the ALS functional rating score (ALSFRS-R) by at least two points during the previous 18 months.
- Live within 120 minute drive from Sheffield
Patient Exclusion Criteria:
- Patients attend another MND care centre in the UK.
- Significant impairment in decision making capacity preventing informed consent by the subject due to a major mental disorder including fronto-temporal dementia.
- Patient unable to use the TiM system due to physical, intellectual or language difficulties and unwilling to permit carer to operate it on their behalf. Patients will be asked to complete two questions used within the TiM system, with, or without the help to their carer to verify their ability to use the system.
- The patient has no eligible informal carer willing to participate in the trial
- Insufficient mobile telephone reception in the patients' home to use the TiM system.
- Any other major impairment that may affect their ability to participate in the study
Carer inclusion criteria
- Age 18 years or older
- Person identified by the patient as the major provider of informal care (emotional and/or practical support) to the patient and provides more than one hour per week of unpaid care
- Carer willing to allow data they provide during the trial to be shared by the research team with their own doctor in the event of serious clinical need.
Carer exclusion criteria
- Significant decision making capacity preventing informed consent due to a major mental disorder.
- Carer unable to use the TiM system due to physical, intellectual or language difficulties. Carers will be asked to complete two questions used within the TiM system to verify their ability to use the system.
- Inability to participate in the study due to other major physical or mental illness or language difficulties.
- Professional carers receiving direct payment for their services.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Sheffield Institute for Translational Neurosciences
Sheffield, S10 2HQ
About this study
Official 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
Motor neurone disease (MND) is a rare but debilitating neurological condition that causes paralysis of the body's 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 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 (a total of 80 participants). Half of the participants will use the telehealth system for a minimum of six months and maximum of eighteen 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.
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.
Read the detailed description
MND is often referred to as amyotrophic lateral sclerosis (ALS) or Lou Gehrig's disease.
- Conditions
- Motor Neuron Disease
- Being tested
- TiM telehealth arm
- Medical subject headings
- Motor Neuron Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TiM telehealth armOther
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Patients and their primary carer will use a weekly telehealth system. This involves a series of questions on a tablet computer that is transmitted to their regional MND care centre for review and action. Receives: Other: TiM telehealth arm |
| Control | No intervention | Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility and acceptability of using the telehealth system from interviews
Recruitment rate, retention rate.
Measured: Up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2015 (estimated)
- Study startSep 2014
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Motor Neuron DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sheffield
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02464748
- Sponsor's protocol ID
- STH_17165
- Other IDs
- 26675465, 17022
- Acronym
- TiM
- Status last verified
- May 2026
- First submitted
- 13 Nov 2014
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT02464748
- Acronym / sponsor ID
- TiM / STH_17165
- Conditions
- Motor Neuron Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University of Sheffield
- Study start
- Sep 2014
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 8 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Motor neurone disease (MND) is a rare but debilitating neurological condition that causes paralysis of the body's 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 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 (a total of 80 participants). Half of the participants will use the telehealth system for a minimum of six months and maximum of eighteen 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.
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.
Detailed description
MND is often referred to as amyotrophic lateral sclerosis (ALS) or Lou Gehrig's disease.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: TiM telehealth armPatients and their primary carer will use a weekly telehealth system. This involves a series of questions on a tablet computer that is transmitted to their regional MND care centre for review and action. |
| Control | No intervention | –Usual care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TiM telehealth arm | Other | Intervention |
Primary outcome
Feasibility and acceptability of using the telehealth system from interviews
Time frame: Up to 18 months
Recruitment rate, retention rate.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TiM telehealth arm in people with Motor Neuron Disease, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility and acceptability of using the telehealth system from interviews (time frame: Up to 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.