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Telehealth in Motor Neurone Disease (TiM)

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ClinicalTrials.gov Identifier: NCT02464748
Recruitment Status : Completed
First Posted : June 8, 2015
Last Update Posted : April 28, 2017
Sponsor:
Collaborator:
University of Sheffield
Information provided by (Responsible Party):
Sheffield Teaching Hospitals NHS Foundation Trust

Brief 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 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.


Condition or disease Intervention/treatment Phase
Motor Neuron Disease Other: TiM telehealth arm Not Applicable

Detailed Description:
MND is often referred to as amyotrophic lateral sclerosis (ALS) or Lou Gehrig's disease.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 77 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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
Study Start Date : September 2014
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016


Arm Intervention/treatment
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.
Other: TiM telehealth arm
No Intervention: Control
Usual care



Primary Outcome Measures :
  1. Feasibility and acceptability of using the telehealth system from interviews [ Time Frame: Up to 18 months ]
    Recruitment rate, retention rate.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02464748


Locations
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United Kingdom
Sheffield Institute for Translational Neurosciences
Sheffield, United Kingdom, S10 2HQ
Sponsors and Collaborators
Sheffield Teaching Hospitals NHS Foundation Trust
University of Sheffield
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Responsible Party: Sheffield Teaching Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02464748    
Other Study ID Numbers: 17165
26675465 ( Registry Identifier: ISRCTN )
17022 ( Registry Identifier: National Institute for Health Research Portfolio ID )
First Posted: June 8, 2015    Key Record Dates
Last Update Posted: April 28, 2017
Last Verified: April 2017
Additional relevant MeSH terms:
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Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases