Clinical trial NCT05299372: Telemonitoring in NIV MND (OptNIVent)
Official title: Optimising the Management of Ventilated Patients and Quality of Life in Motor Neurone Disease: a Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Motor Neuron Disease, Amyotrophic Lateral Sclerosis
Keywords: non-invasive ventilation
Telehealth
Telemonitoring
Lead sponsor: Liverpool University Hospitals NHS Foundation Trust
Sponsor class: OTHER_GOV
First posted: 2022-03-29
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Acceptability - Qualitative data through semi-structured interviews and focus groups
timeFrame: Qualitative data will be conducted at 3-month
measure: Usability - Qualitative data through semi-structured interviews and focus groups
timeFrame: Qualitative data will be conducted at 3-month
Secondary outcomes:
measure: Patient Reported Outcome Measurement - Neurological Fatigue Index for MND
timeFrame: Baseline and then 6-weekly up to 24 weeks
measure: Patient Reported Outcome Measurement - Epworth Sleepiness Scale
timeFrame: Baseline and then 6-weekly up to 24 weeks
measure: Patient Reported Outcome Measurement - Dyspnoea-12
timeFrame: Baseline and then 6-weekly up to 24 weeks
measure: Patient Reported Outcome Measurement - revised Amyotrophic Lateral Sclerosis Functional Rating Scale
timeFrame: Baseline and at 3-month and 6-month
measure: Patient Reported Outcome Measurement - Hospital Anxiety and Depression Scale
timeFrame: Baseline and at 3-month and 6-month
measure: Patient Reported Outcome Measurement - the World Health Organization Quality of Life Scale-BREF
timeFrame: Baseline and at 3-month and 6-month
measure: Patient Reported Outcome Measurement - 5-level EQ-5D
timeFrame: Baseline and at 3-month and 6-month
measure: Patient Reported Outcome Measurement - General Satisfaction
timeFrame: Baseline and at 3-month and 6-month
measure: Patient Reported Outcome Measurement - Access, Availability and Convenience
timeFrame: Baseline and at 3-month and 6-month
measure: Self-Reported Outcome Measurement - Caregiving Distress Scale
timeFrame: Baseline and at 3-month and 6-month
measure: Service evaluation
timeFrame: At the end of study i.e. at 6-month
Other outcomes:
Locations:
Study officials:
affiliation: Liverpool University Hospitals NHS Foundation Trust
name: Robert M Angus, MRCP, FRCP
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ando H, Ashcroft-Kelso H, Halhead R, Young CA, Chakrabarti B, Levene P, Cousins R, Angus RM. Incorporating self-reported questions for telemonitoring to optimize care of patients with MND on noninvasive ventilation (MND OptNIVent). Amyotroph Lateral Scler Frontotemporal Degener. 2019 Aug;20(5-6):336-347. doi: 10.1080/21678421.2019.1587630. Epub 2019 Mar 26.