Condition category
Nervous System Diseases
Date applied
05/09/2014
Date assigned
05/09/2014
Last edited
05/09/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Esther Hobson

ORCID ID

Contact details

Sheffield Institute for Translational Neuroscience
B12
385A Glossop Road
Sheffield
S10 2HQ
United Kingdom
e.hobson@sheffield.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

17022

Study information

Scientific title

Acronym

Telehealth in Motor Neurone Disease

Study hypothesis

Motor neurone disease 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. 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.

Ethics approval

14/yh/1068; First MREC approval date 15/07/2014

Study design

Randomised; Interventional; Design type: Diagnosis, Process of Care, Treatment

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Topic: Dementias and neurodegeneration; Subtopic: Motor neurone disease; Disease: Motor neurone disease

Intervention

TiM telehealth system, The TiM telehealth system is a system through which patients and their carers can enter data about their conditon 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 conditon. 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

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Feasibility and acceptability; Timepoint(s): End of the trial

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/09/2014

Overall trial end date

01/03/2016

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 80; UK Sample Size: 80

Participant 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 patient’s home (this is required to use the TiM system)
6. Any other major impairment that may affect their ability to participate in the study

Recruitment start date

01/09/2014

Recruitment end date

01/03/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Sheffield Institute for Translational Neuroscience
Sheffield
S10 2HQ
United Kingdom

Sponsor information

Organisation

Sheffield Teaching Hospitals NHS Trust (UK)

Sponsor details

Research Department
11 Broomfield Road
Sheffield
S10 2SE
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Charity

Funder name

Motor Neurone Disease Association (MNDA) (UK)

Alternative name(s)

MNDA

Funding Body Type

private sector organisation

Funding Body Subtype

professional associations and societies

Location

United Kingdom

Funder name

National Institute for Health Research (UK); Grant Codes: Research contract

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes