Telemonitoring in NIV MND (OptNIVent)

Motor Neuron Disease, Amyotrophic Lateral Sclerosis Clinical Trial

— OptNIVent  

Official title:

Optimising the Management of Ventilated Patients and Quality of Life in Motor Neurone Disease: a Pilot Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05299372
• Other study ID #: 767/14
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 25, 2022
• Est. completion date: December 31, 2022

Study information

• Verified date: March 2022
• Source: Liverpool University Hospitals NHS Foundation Trust
• Contact: Hikari Ando, PhD
• Phone: 0151529
• Email: hikari.ando[@]nhs.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 15
• Est. completion date: December 31, 2022
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease
• Motor Neuron Disease, Amyotrophic Lateral Sclerosis

Intervention

Other:
• Telemonitoring via Careportal®
The question sets and overnight oximetry results will be monitored and screened by a call centre commissioned by the Liverpool Clinical Commissioning Group (LCCG). The call centre will screen the weekly data and contact clinicians where appropriate (i.e. NIV team, MND specialist nurse, or patient's GP). PVI data will be examined by NIV physiotherapists, where required, following the contact from LCCG to ensure the maximum benefits of NIV to patients.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Liverpool University Hospitals NHS Foundation Trust

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acceptability - Qualitative data through semi-structured interviews and focus groups	Qualitative data will be collected through focus groups with participants, their lay caregivers, and clinicians. Separate focus groups will be conducted for the three participant groups with an option of individual interviews for patients and lay caregivers.	Qualitative data will be conducted at 3-month
Primary	Usability - Qualitative data through semi-structured interviews and focus groups	Qualitative data will be collected through focus groups with participants, their lay caregivers, and clinicians. Separate focus groups will be conducted for the three participant groups with an option of individual interviews for patients and lay caregivers.	Qualitative data will be conducted at 3-month
Secondary	Patient Reported Outcome Measurement - Neurological Fatigue Index for MND	13-item questionnaire assessing fatigue experienced by people with motor neurone disease. The questionnaire consists of two sub-scales: Weakness sub-scale and Energy sub-scale. Eight items make up the Summary Fatigue scale with the total scores range from 0 to 24. Higher scores indicate higher levels of fatigue	Baseline and then 6-weekly up to 24 weeks
Secondary	Patient Reported Outcome Measurement - Epworth Sleepiness Scale	8-item questionnaire to measure general levels of sleepiness. Total scores range from 0 to 24. Higher scores indicate higher levels of sleepiness.	Baseline and then 6-weekly up to 24 weeks
Secondary	Patient Reported Outcome Measurement - Dyspnoea-12	12-item questionnaire to measure overall breathlessness severity. Total scores range from 0 to 36. Higher scores indicate higher breathless severity.	Baseline and then 6-weekly up to 24 weeks
Secondary	Patient Reported Outcome Measurement - revised Amyotrophic Lateral Sclerosis Functional Rating Scale	12-item questionnaire to monitor the disease progression covering bulbar, motor and respiratory function. Total scores range from 0 to 48. Higher scores indicate better function.	Baseline and at 3-month and 6-month
Secondary	Patient Reported Outcome Measurement - Hospital Anxiety and Depression Scale	14-item questionnaire to measure anxiety and depression levels. The questionnaire consists of anxiety sub-scale and depression sub-scale. Scores for each sub-scale range from 0 to 21. Higher scores indicate greater anxiety/depression levels.	Baseline and at 3-month and 6-month
Secondary	Patient Reported Outcome Measurement - the World Health Organization Quality of Life Scale-BREF	26-item questionnaire consists of Physical Health domain, Psychological domain, Social relationships domain, and Environment domain in addition to Overall QoL (1-item) and General Health (1-item) facets. Total scores range from 0 to 100. Higher scores indicate indicate higher quality of life.	Baseline and at 3-month and 6-month
Secondary	Patient Reported Outcome Measurement - 5-level EQ-5D	The questionnaire consists of 5-item to measure health based on five domains: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each domain has 5 levels indicating worsening health, from having no problems to having severe problems. The questionnaire also contain one visual analogue scale measuring health-reported health: 0 indicates worst health while 100 indicates the best health.	Baseline and at 3-month and 6-month
Secondary	Patient Reported Outcome Measurement - General Satisfaction	6-item General Satisfaction sub-scale from Patient Satisfaction Questionnaire. Total scores range from 6 to 30. Higher scores indicate greater satisfaction.	Baseline and at 3-month and 6-month
Secondary	Patient Reported Outcome Measurement - Access, Availability and Convenience	12-item Access, Availability and Convenience sub-scale from Patient Satisfaction Questionnaire. Total scores range from 12 to 60. Higher scores indicate greater access, availability and convenience.	Baseline and at 3-month and 6-month
Secondary	Self-Reported Outcome Measurement - Caregiving Distress Scale	17-item questionnaire to measure caregiver distress, covering five dimensions: Relationship distress, Emotional burden, Social impact, Care-receiver demands, and Personal cost. Total scores range from 0 to 68. Higher scores indicate greater distress.	Baseline and at 3-month and 6-month
Secondary	Service evaluation	Patient Level Information and Costing System (PLICS)	At the end of study i.e. at 6-month