- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02464748
Telehealth in Motor Neurone Disease (TiM)
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.
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Sheffield, United Kingdom, S10 2HQ
- Sheffield Institute for Translational Neurosciences
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
o 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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No Intervention: Control
Usual care
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Experimental: Intervention
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility and acceptability of using the telehealth system from interviews
Time Frame: Up to 18 months
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Recruitment rate, retention rate.
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Up to 18 months
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Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17165
- 17022 (Registry Identifier: National Institute for Health Research Portfolio ID)
- 26675465 (Registry Identifier: ISRCTN)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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