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Telehealth in Motor Neurone Disease (TiM)

Primary Purpose

Motor Neuron Disease

Status

Completed

Phase

Not Applicable

Locations

United Kingdom

Study Type

Interventional

Intervention

TiM telehealth arm

About this trial

This is an interventional supportive care trial for Motor Neuron Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Sheffield Institute for Translational Neurosciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

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.

Usual care

Outcomes

Primary Outcome Measures

Feasibility and acceptability of using the telehealth system from interviews

Recruitment rate, retention rate.

Secondary Outcome Measures

Full Information

NCT ID

NCT02464748

First Posted

November 13, 2014

Last Updated

April 26, 2017

Sponsor

Sheffield Teaching Hospitals NHS Foundation Trust

Collaborators

University of Sheffield

1. Study Identification

Unique Protocol Identification Number

NCT02464748

Brief Title

Telehealth in Motor Neurone Disease

Acronym

TiM

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 Type

Interventional

2. Study Status

Record Verification Date

April 2017

Overall Recruitment Status

Completed

Study Start Date

September 2014 (undefined)

Primary Completion Date

April 2016 (Actual)

Study Completion Date

April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sheffield Teaching Hospitals NHS Foundation Trust

Collaborators

University of Sheffield

4. Oversight

Data Monitoring Committee

5. Study Description

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.

Detailed Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Motor Neuron Disease

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

77 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intervention

Arm Type

Experimental

Arm Description

Arm Title

Control

Arm Type

No Intervention

Arm Description

Usual care

Intervention Type

Other

Intervention Name(s)

TiM telehealth arm

Primary Outcome Measure Information:

Title

Feasibility and acceptability of using the telehealth system from interviews

Description

Recruitment rate, retention rate.

Time Frame

Up to 18 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Facility Information:

Facility Name

Sheffield Institute for Translational Neurosciences

City

Sheffield

ZIP/Postal Code

S10 2HQ

Country

United Kingdom

12. IPD Sharing Statement

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Telehealth in Motor Neurone Disease

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