Clinical trial: Telehealth in Motor Neurone Disease (NCT02464748)

Eligibility criteria:
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.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


Patient description (medical language): A 47-year-old man comes to the clinic for the follow up of his neuromuscular disease. He experienced gradual, progressive weakness of the left upper extremity over the last year.  Over the last few months, he has also noticed weakness in the right upper extremity.  BP is 120/75, PR is 80 and temperature is 37 C. Reflexes are brisk in the upper extremities, and the plantar responses are extensor.  Mild gait ataxia is present. The patient is under treatment of Riluzole 50 mg BID with the diagnosis of ALS.

Patient description (patient's own words): I've been suffering from a neuromuscular disease for a while now, and I went to my doctor's office. I'm now a 47-year-old man and over the past year I experienced a progressive and gradual weakness of my left upper extremity, and over the past month, I also noticed a weakness over my right upper extremity. My heart rate was 120/75, and my  PR was 80 with 37°C for temperature. My reflexes are not good in my upper extremities, and I have trouble with my balance. I'm also under Exservan 50 mg for my sclerosis.

Does the patient match the trial criteria? 1