- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05299372
Telemonitoring in NIV MND (OptNIVent) (OptNIVent)
March 18, 2022 updated by: Liverpool University Hospitals NHS Foundation Trust
Optimising the Management of Ventilated Patients and Quality of Life in Motor Neurone Disease: a Pilot Study
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.
Study Overview
Status
Not yet recruiting
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
15
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Hikari Ando, PhD
- Phone Number: 0151529
- Email: hikari.ando@nhs.net
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
OTHER: 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®.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Qualitative data will be conducted at 3-month
|
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.
|
Qualitative data will be conducted at 3-month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Baseline and then 6-weekly up to 24 weeks
|
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.
|
Baseline and then 6-weekly up to 24 weeks
|
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.
|
Baseline and then 6-weekly up to 24 weeks
|
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.
|
Baseline and at 3-month and 6-month
|
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.
|
Baseline and at 3-month and 6-month
|
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.
|
Baseline and at 3-month and 6-month
|
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.
|
Baseline and at 3-month and 6-month
|
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.
|
Baseline and at 3-month and 6-month
|
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.
|
Baseline and at 3-month and 6-month
|
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.
|
Baseline and at 3-month and 6-month
|
Service evaluation
Time Frame: At the end of study i.e. at 6-month
|
Patient Level Information and Costing System (PLICS)
|
At the end of study i.e. at 6-month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Robert M Angus, MRCP, FRCP, Liverpool University Hospitals NHS Foundation Trust
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ANTICIPATED)
April 25, 2022
Primary Completion (ANTICIPATED)
October 31, 2022
Study Completion (ANTICIPATED)
December 31, 2022
Study Registration Dates
First Submitted
September 21, 2021
First Submitted That Met QC Criteria
March 18, 2022
First Posted (ACTUAL)
March 29, 2022
Study Record Updates
Last Update Posted (ACTUAL)
March 29, 2022
Last Update Submitted That Met QC Criteria
March 18, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 767/14
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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