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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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17 October 2016 |
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Main ID: |
ISRCTN17560073 |
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Date of registration:
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10/02/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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EncoreAnywhere use in motor neurone disease
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Scientific title:
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Monitoring and promoting adherence to non-invasive ventilation in motor neurone disease using EncoreAnywhere telemonitoring |
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Date of first enrolment:
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22/01/2016 |
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Target sample size:
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40 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN17560073 |
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Study type:
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Interventional |
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Study design:
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Randomised; Interventional; Design type: Process of Care, Treatment (Treatment)
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Phase:
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Esther
Hobson |
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Address:
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Sheffield Institute for Translational Neuroscience
B12, 385A Glossop Road
S10 2HQ
Sheffield
United Kingdom |
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Telephone:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Aged 18 years and over
2. Patients with motor neurone disease diagnosed by a consultant neurologist
3. Patients receiving care from the Sheffield Teaching Hospitals NHS Trust MND clinic
4. Patients with respiratory failure diagnosed by the clinical team
5. Determined to be suitable for and willing to commence non-invasive ventilation including the EncoreAnywhere features as part of their usual care at the Royal Hallamshire Hospital MND clinic
Exclusion criteria: 1. Patients already established on non-invasive ventilation e.g. in obstructive sleep apnoea
2. Those with no mobile internet reception in their homes (required to use EncoreAnywhere)
3. Patients unable to give informed consent
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Topic: Dementias and neurodegeneration; Subtopic: All Diagnoses, Motor neurone disease; Disease: Motor neurone disease
Nervous System Diseases
Motor neurone disease
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Intervention(s)
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Participants are randomly allocated to one of two groups using computerised 1:1 block randomisation.
Participants in both groups are given instructions to use NIV, which involves wearing a face mask connected to a ventilator (breathing machine) every night and in the daytime if needed. All patients have access to telephone advice from the respiratory therapist as well as online instructions using www.niv.mymnd.org.uk. All patients will have the EncoreAnywhere system installed on their breathing machine which will automatically collect information about their use of the machine.
Group 1: Patients will receive usual care plus monitoring using the EncoreAnywhere system for 3 months. The staff caring for patients in the intervention group will be able to use the EncoreAnywhere system to see the data it collects every day, and will be able to contact patients if they detect a problem with the machine or if the patient is not using it effectively immediately.
Group 2: Patients will have their data collected automatically by the EncoreAnywhere system but it will only be available to the staff looking after the patients after the study has finished.
Participants in both groups are followed up at three months.
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Primary Outcome(s)
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Adherence to NIV is measured using data collected from automatically from the EncoreAnywhere system at 3 months.
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Secondary Outcome(s)
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1. Adherence to NIV is measured using data collected from automatically from the EncoreAnywhere system at 1, 2, 4, 8 and 12 weeks
2. Efficacy of NIV:
2.1. Number of episodes of leak or obstruction collected from automatically from the EncoreAnywhere system at 1, 2, 4, 8 and 12 weeks
2.2. Patient satisfaction/perception of service delivery is measured using a patient questionnaire designed for the study at 3 months
2.3. NIV tolerance is measured using a patient questionnaire designed for the study at 1 and 3 months
2.4. Presence of symptoms are measured using a patient questionnaire designed for the study at 1 and 3 months
2.5. Quality of life using patient questionnaire RAND-36 at 3 months
2.6. Daytime arterial PaCO2 and PaO2 using information collected from clinical notes at 3 months
2.7. Home nocturnal PaCO2 and PaO2 average, mean and episodes of desaturation is measured using TOSCA at 1 and 3
3. Recruitment and retention rates:
3.1. Adherence to data collection points collected from study records at 3 months
3.2. Standard deviation of primary outcome measure (to predict sample size for future evaluation) at 3 months
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Source(s) of Monetary Support
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National Institute for Health Research, Philips Healthcare
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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