Non-invasive ventilation in motor neuron disease Respiratory
Conditions
Interventions
The DENIM Trial is an implementation hybrid trial, testing a theory-based implementation strategy aimed at improving the delivery of non-invasive ventilation (NIV) to people with motor neuron disease
Sponsors
Sheffield Teaching Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
18 Years to 120 Years
Inclusion criteria
Inclusion criteria: Trial participant inclusion criteria: 1. Patients aged 18 years or over 2. Have a diagnosis of MND confirmed by a consultant neurologist 3. With a clinical diagnosis of respiratory insufficiency according to local protocols, published guidelines and/or specialist opinion 4. Respiratory insufficiency judged by the treating clinician to be severe enough to warrant long term domiciliary NIV and requiring NIV optimisation within the duration of the study (12 weeks) 5. NIV initiated at home, in an outpatient setting or in hospital if hospital stay is less than or equal to 3 days post NIV initiation 6. Able to provide informed consent. Adults agreeing to try NIV and able to provide assent (evidence of agreement to take part in the study) but unable to provide informed consent will be able to participate if a consultee (close relative, informal carer, immediate care team) provides a consultee declaration Process evaluation patient interviews inclusion criteria: 1. Have consented to participate in DENIM 2. Are in the intervention arm 3. Are able and willing to participate in interviews (various options for facilitation available) and/or ethnographic observations 4. If relevant, are willing to share their preferred language for participation with the research team, to allow an appropriate researcher to be identified. Process evaluation family/carer inclusion criteria: 5. Relative/friend has consented to participate in DENIM 6. Are able and willing to participate in interviews and/or ethnographic observations Process evaluation staff interview inclusion criteria: 7. Direct contact with at least one patient who is participating in DENIM 8. Are able and willing to participate in interviews and/or ethnographic observations ACCESS sub study inclusion criteria: 1. From an ethnic minority and/or where the patient’s main language is not English 2. Or with low levels of digital health literacy (either those identified by the site teams or those scoring < 7 on the 3-Item Measure of Digital Health Care Literacy at baseline ) 3. Or women over 80 years with bulbar onset disease
Exclusion criteria
Exclusion criteria: 1. Already initiated on NIV/CPAP for MND or another reason 2. Using tracheostomy ventilation 3. No way to connect the ventilation software to the internet whilst in the community 4. Patients not requiring optimisation within 12 weeks (e.g. those given the machine but are unable to commence NIV due to lack of social care).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| NIV usage (the number of days in which patients use NIV for >4hr/day during week 9-12), measured automatically by the ventilator machine.: 1.1. NIV usage: NIV usage from ventilator machine (first 14 days, first 28 days) 1.2. Calculation of the number of days in which patients use NIV for >4hr/day | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. NIV usage (first 14 days, first 28 days, weeks 9-12) measured by the ventilator machine 1.1. The average (mean) daily usage 1.2. The number of patients achieving >4hr/day for >70% of nights 2. Nocturnal respiratory insufficiency, measured by overnight oximetry, for a single night at week 12 3. Time spent with oxygen saturations <90%, measured by overnight oximetry, for a single night at week 12 4. Time spent in oxygen desaturation index (ODI) of 4%, measured by overnight oximetry, for a single night at week 12 5. Patient reported outcome measures: collected at baseline and week 12 5.1. Quality of life (McGill quality of life questionnaire, developed for patients with a life-limiting illness) 5.2. Dyspnoea-12 (measuring respiratory symptoms, sensitive to change) 5.3. S3NIV (measures respiratory symptoms, sleep quality, and NIV-related side effects) 6. Health and social care resource use questionnaire, including EQ5D, collected from participant at week 12 7. Survival, collected from medical records, follow-up minimum 12 weeks, maximum of 27 months (week 108) Exploratory outcomes 8. Ventilator effectiveness, collected from data report from ventilator for the first 14 days, first 28 days, and weeks 9-12 8.1. Tidal volumes 8.2. Ventilator asynchronies 8.3. Apnoea hypopnoea index 8.4. Leak 9. Nocturnal evidence of REM-related desaturation through overnight oximetry, Week 12 9.1. Evidence of REM-related desaturation trace Explanatory implementation outcomes 10. Assessment of changes in barriers and facilitators to implementation at site level, pre and post intervention (NOMAD survey given to healthcare professionals during the site control arm, week 4 after intervention switch and end of the trial) 11. Fidelity: Percentage completeness of the first consultant workbook (intervention arm), assessed throughout site intervention arm 12. Fidelity: Number of times remote monitoring was reviewed at the pre-specific times, assessed throughout sit | — |
Countries
England, United Kingdom
Contacts
Public ContactCarla Girling
Outcome results
None listed