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Telemonitoring in NIV MND (OptNIVent) (OptNIVent)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05299372
Recruitment Status : Not yet recruiting
First Posted : March 29, 2022
Last Update Posted : March 29, 2022
Sponsor:
Information provided by (Responsible Party):
Liverpool University Hospitals NHS Foundation Trust

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.

Condition or disease Intervention/treatment Phase
Motor Neuron Disease, Amyotrophic Lateral Sclerosis Other: Telemonitoring via Careportal® Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Optimising the Management of Ventilated Patients and Quality of Life in Motor Neurone Disease: a Pilot Study
Estimated Study Start Date : April 25, 2022
Estimated Primary Completion Date : October 31, 2022
Estimated Study Completion Date : December 31, 2022


Arm Intervention/treatment
Telemonitoring via Careportal®
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®.
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.




Primary Outcome Measures :
  1. Acceptability - Qualitative data through semi-structured interviews and focus groups [ Time Frame: Qualitative data will be conducted at 3-month ]
    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.

  2. Usability - Qualitative data through semi-structured interviews and focus groups [ Time Frame: Qualitative data will be conducted at 3-month ]
    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.


Secondary Outcome Measures :
  1. Patient Reported Outcome Measurement - Neurological Fatigue Index for MND [ Time Frame: Baseline and then 6-weekly up to 24 weeks ]
    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

  2. Patient Reported Outcome Measurement - Epworth Sleepiness Scale [ Time Frame: Baseline and then 6-weekly up to 24 weeks ]
    8-item questionnaire to measure general levels of sleepiness. Total scores range from 0 to 24. Higher scores indicate higher levels of sleepiness.

  3. Patient Reported Outcome Measurement - Dyspnoea-12 [ Time Frame: Baseline and then 6-weekly up to 24 weeks ]
    12-item questionnaire to measure overall breathlessness severity. Total scores range from 0 to 36. Higher scores indicate higher breathless severity.

  4. Patient Reported Outcome Measurement - revised Amyotrophic Lateral Sclerosis Functional Rating Scale [ Time Frame: Baseline and at 3-month and 6-month ]
    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.

  5. Patient Reported Outcome Measurement - Hospital Anxiety and Depression Scale [ Time Frame: Baseline and at 3-month and 6-month ]
    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.

  6. Patient Reported Outcome Measurement - the World Health Organization Quality of Life Scale-BREF [ Time Frame: Baseline and at 3-month and 6-month ]
    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.

  7. Patient Reported Outcome Measurement - 5-level EQ-5D [ Time Frame: Baseline and at 3-month and 6-month ]
    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.

  8. Patient Reported Outcome Measurement - General Satisfaction [ Time Frame: Baseline and at 3-month and 6-month ]
    6-item General Satisfaction sub-scale from Patient Satisfaction Questionnaire. Total scores range from 6 to 30. Higher scores indicate greater satisfaction.

  9. Patient Reported Outcome Measurement - Access, Availability and Convenience [ Time Frame: Baseline and at 3-month and 6-month ]
    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.

  10. Self-Reported Outcome Measurement - Caregiving Distress Scale [ Time Frame: Baseline and at 3-month and 6-month ]
    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.

  11. Service evaluation [ Time Frame: At the end of study i.e. at 6-month ]
    Patient Level Information and Costing System (PLICS)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05299372


Contacts
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Contact: Hikari Ando, PhD 0151529 hikari.ando@nhs.net

Sponsors and Collaborators
Liverpool University Hospitals NHS Foundation Trust
Investigators
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Principal Investigator: Robert M Angus, MRCP, FRCP Liverpool University Hospitals NHS Foundation Trust
Publications:
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Responsible Party: Liverpool University Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT05299372    
Other Study ID Numbers: 767/14
First Posted: March 29, 2022    Key Record Dates
Last Update Posted: March 29, 2022
Last Verified: March 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Liverpool University Hospitals NHS Foundation Trust:
non-invasive ventilation
Telehealth
Telemonitoring
Additional relevant MeSH terms:
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Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases