Telemonitoring in NIV MND (OptNIVent)

Liverpool University Hospitals NHS Foundation Trust

Status: Unknown

Conditions: Motor Neuron Disease, Amyotrophic Lateral Sclerosis

Treatments: Other: Telemonitoring via Careportal®

Study type: Interventional

Funder types: Other

Identifiers

NCT05299372

767/14

Details and patient eligibility

About

This is a feasibility study of telemonitoring system for people with MND/ALS, who are on NIV, via a call centre operated by a local clinical commissioning group.

Full description

This study will test the feasibility of previously developed Telehealth system, using a device called Careportal®, to monitor people with MND/ALS who are using non-invasive ventilation (NIV). The Careportal® is a CE marked portable tablet computer device allowing telecommunication between patients and their care team through bespoke question sets, overnight oximetry test, and patient-ventilator interaction(PVI) data. Previously, the weekly telemonitoring via Careportal® was found to be an effective method to monitor symptom changes, allowing clinicians to optimise the care of ventilated patients with MND. This study will assess the practicality of using Careportal® in the care of ventilated patients with MND by monitoring patients through a patient support call centre. The call centre will screen the data and liaise with appropriate clinicians regarding changes of symptoms.

Enrollment: 15 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria (Patients):

• Confirmed diagnosis of MND with respiratory muscle weakness
• Adults who are capable of informed consent
• Patients for whom we anticipate survival of 6 months or more
• Able to communicate with an interviewer. Alternative communication methods will be used as required in order to mitigate communication difficulties.

Exclusion Criteria (Patients):

• Patients who have declined NIV

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Telemonitoring via Careportal®

Other group

Description:

Participants will be prompted by the device to answer two sets of questions every week: 10 items (1 nested) in the morning and 16 items (4 nested) in the evening. Also on a weekly basis, patients will be prompted to perform overnight oximetry test, and upload patient-ventilator interaction data (PVI) via Careportal®.

Treatment:

Other: Telemonitoring via Careportal®