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.
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
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
15
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.
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.
Time frame: Qualitative data will be conducted at 3-month
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.
Time frame: Qualitative data will be conducted at 3-month
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
Time frame: Baseline and then 6-weekly up to 24 weeks
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.
Time frame: Baseline and then 6-weekly up to 24 weeks
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.
Time frame: Baseline and then 6-weekly up to 24 weeks
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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.
Time frame: Baseline and at 3-month and 6-month
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.
Time frame: Baseline and at 3-month and 6-month
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.
Time frame: Baseline and at 3-month and 6-month
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.
Time frame: Baseline and at 3-month and 6-month
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.
Time frame: Baseline and at 3-month and 6-month
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.
Time frame: Baseline and at 3-month and 6-month
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.
Time frame: Baseline and at 3-month and 6-month
Service evaluation
Patient Level Information and Costing System (PLICS)
Time frame: At the end of study i.e. at 6-month