Optimising the Management of Ventilated Patients and Quality of Life in Motor Neurone Disease: a Pilot Study
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 15
- Primary Endpoint
- Acceptability - Qualitative data through semi-structured interviews and focus groups
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
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.
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 Outcomes
- Patient Reported Outcome Measurement - revised Amyotrophic Lateral Sclerosis Functional Rating Scale(Baseline and at 3-month and 6-month)
- Patient Reported Outcome Measurement - Epworth Sleepiness Scale(Baseline and then 6-weekly up to 24 weeks)
- Patient Reported Outcome Measurement - Access, Availability and Convenience(Baseline and at 3-month and 6-month)
- Patient Reported Outcome Measurement - Hospital Anxiety and Depression Scale(Baseline and at 3-month and 6-month)
- Self-Reported Outcome Measurement - Caregiving Distress Scale(Baseline and at 3-month and 6-month)
- Patient Reported Outcome Measurement - Dyspnoea-12(Baseline and then 6-weekly up to 24 weeks)
- Patient Reported Outcome Measurement - General Satisfaction(Baseline and at 3-month and 6-month)
- Patient Reported Outcome Measurement - Neurological Fatigue Index for MND(Baseline and then 6-weekly up to 24 weeks)
- Patient Reported Outcome Measurement - the World Health Organization Quality of Life Scale-BREF(Baseline and at 3-month and 6-month)
- Patient Reported Outcome Measurement - 5-level EQ-5D(Baseline and at 3-month and 6-month)
- Service evaluation(At the end of study i.e. at 6-month)