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Trial registered on ANZCTR


Registration number
ACTRN12620000682943
Ethics application status
Approved
Date submitted
5/05/2020
Date registered
15/06/2020
Date last updated
15/06/2020
Date data sharing statement initially provided
15/06/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
A feasibility study of starting non-invasive ventilation in the home.
Scientific title
Home-based Non-invasive Ventilation Implementation and Tele-monitoring: A Pilot Safety and Feasibility Randomised Controlled Trial
Secondary ID [1] 301192 0
None
Universal Trial Number (UTN)
Trial acronym
NIV@Home
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Motor Neurone Disease 317338 0
Other disorders with, or at imminent risk of, chronic hypercapnic ventilatory failure 317339 0
Condition category
Condition code
Respiratory 315447 315447 0 0
Other respiratory disorders / diseases
Neurological 315620 315620 0 0
Neurodegenerative diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention “NIV@Home” will involve home implementation of non-invasive ventilation (NIV) with remote patient monitoring (tele-monitoring).

A suitable qualified physiotherapist from the specialist NIV service provider will perform the non-invasive ventilation set up and deliver the education in participants' homes. Non-invasive ventilators with cloud-based monitoring software and associated equipment will be provided to participants. Education resources will be standardised across NIV@Home (intervention) and usual care (control) arms using an information booklet tailored to the participant detailing their equipment list, setup, cleaning and maintenance and relevant clinical contacts. No specific advice will be given to trial participants regarding recommended usage beyond that provided clinically. This advice is provided by treating clinical staff commencing with medical staff at initial discussion about referral, at setup and at clinical review. This typically includes recommendations to “use overnight, or as much as tolerated per day”.

Physiotherapy staff will review non-invasive ventilation usage weekly for 12 weeks after home implementation using the cloud-based monitoring software. If non-invasive ventilation usage has averaged less than four hours per night for a week (non-adherent), then initial contact via telephone and/or email will be made to discuss usage and troubleshoot. At this time, all other cloud-based device signals will be made available to the physiotherapist for review to assist with troubleshooting (some or all of the following depending on device; intentional and unintentional leak, pressures, estimated alveolar volume, proportion of ventilator assisted individual breaths). Any non-invasive device alterations that are deemed necessary will be made remotely. A home visit will be conducted if deemed clinically appropriate.

In both trial arms, clinical contact or review initiated by the ventilator assisted individual will be managed according to current policies and procedures (initial phone contact followed by Outreach nursing home visits or hospital outpatient attendance or re-admission as required). As in the usual care arm, ventilator assisted individuals will be encouraged to contact the Outreach service as necessary to address any concerns.
Intervention code [1] 317497 0
Treatment: Other
Comparator / control treatment
Usual care at Austin Health involves a hospital day admission for non-invasive ventilation implementation. The admission typically encompasses medical and nursing assessment, mask-fitting and non-invasive ventilation device setting determination by specialist physiotherapy staff and discharge education and resources (see below for more detail) delivered by Victorian Respiratory Support Service Outreach nursing staff.

Non-invasive ventilators with cloud-based monitoring software and associated equipment will be provided to participants. Education resources will be standardised across NIV@Home (intervention) and usual care (control) arms using an information booklet tailored to the participant detailing their equipment list, setup, cleaning and maintenance and relevant clinical contacts. No specific advice will be given to trial participants regarding recommended usage beyond that provided clinically. This advice is provided by treating clinical staff commencing with medical staff at initial discussion about referral, at setup and at clinical review. This typically includes recommendations to “use overnight, or as much as tolerated per day”.

Ventilator assisted individuals are encouraged to contact the service as necessary to address any concerns. The physiotherapy staff routinely contact the person with non-invasive ventilation after two weeks to review progress, address any concerns that have arisen and to schedule a review sleep study at approximately 10 weeks after implementation. The review sleep study determines efficacy or otherwise of non-invasive ventilation settings and adjustments are made.
Control group
Active

Outcomes
Primary outcome [1] 323694 0
Primary outcome. Difference in the proportion of participants using non-invasive ventilation as recorded via telemonitoring for more than four hours per day during the 12 week trial period
Timepoint [1] 323694 0
During the 12-week trial period.
Secondary outcome [1] 382635 0
Average non-invasive ventilation use (hours per day) as recorded via telemonitoring.
Timepoint [1] 382635 0
During the 12-week trial period.
Secondary outcome [2] 382636 0
Number of days where non-invasive ventilation usage as recorded via telemonitoring is greater than four hours.
Timepoint [2] 382636 0
During the 12-week trial period.
Secondary outcome [3] 382637 0
Changes in daytime sleepiness (Epworth Sleepiness Scale).
Timepoint [3] 382637 0
Baseline and 12-weeks after non-invasive ventilation implementation.
Secondary outcome [4] 382638 0
Changes in generic health-related quality of life (Assessment of Quality of Life – 8 Dimensions, AQoL-8D).
Timepoint [4] 382638 0
Baseline and 12-weeks after non-invasive ventilation implementation.
Secondary outcome [5] 382639 0
Changes in disease-specific health-related quality of life in participants with Motor Neurone Disease (Amyotrophic Lateral Sclerosis Functional Rating Scale Revised, ALSFRS-R; Severe Respiratory Insufficiency, SRI).
Timepoint [5] 382639 0
Baseline and 12-weeks after non-invasive ventilation implementation.
Secondary outcome [6] 382640 0
Changes in carer burden for family members of participants (12-item Zarit Burden Interview, ZBI-12).
Timepoint [6] 382640 0
Baseline and 12-weeks after non-invasive ventilation implementation.
Secondary outcome [7] 382641 0
Qualitative semi-structured interviews with participants and their families to explore experience of the service model and the trial.
Timepoint [7] 382641 0
At 12 weeks after non-invasive ventilation implementation.
Secondary outcome [8] 382642 0
The costs of the intervention and control groups will be compared using participant and therapist diaries (clinical and non-clinical contact time, travel time and distance, equipment utilised and hospital readmissions).
Timepoint [8] 382642 0
During the 12-week trial period.
Secondary outcome [9] 382643 0
Actigraphy: seven days of physical activity, sleep and vital signs data from Biovotion Everion device.
Timepoint [9] 382643 0
Baseline and 12-weeks after non-invasive ventilation implementation.

Eligibility
Key inclusion criteria
Adults (aged 18 years and older) referred to the Victorian Respiratory Support Service at Austin Health for initiation of non-invasive ventilation (NIV) deemed clinically suitable by the referring respiratory physician.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Potential participants will be excluded if there is no mobile network coverage in their homes to enable non-invasive ventilation device data uploads, clinical instability, unable to provide informed consent, not proficient in English or unacceptable home visit staff safety risk.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will be concealed through the use of sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Following informed consent participants will be randomised 1:1 to either the intervention or control group. Randomisation will be stratified by the presence (yes or no) of Motor Neurone Disease and bulbar symptoms (yes or no) defined as documented dysphagia, dysarthria, drooling, and/or alterations on video fluoroscopy at study inclusion. Blocked randomisation will be performed using a randomisation table created by computer software (i.e. computerised sequence generation with randomly generated block sizes).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety
Statistical methods / analysis
The primary study comparator for this pilot safety and feasibility randomised controlled trial is non-invasive ventilation (NIV) usage. The hypothesis is that home NIV initiation will be non-inferior to initiation in hospital as defined by the proportion of ventilator assisted individuals using non-invasive ventilation for more than four hours per night during the trial. Usage will also be summarized descriptively as average non-invasive ventilation use (hours per day) and the number of days where non-invasive ventilation usage was greater than four hours. This study is not powered to achieve the primary outcome (NIV usage). This is a safety and feasibility study to prepare for a planned multi-site randomised randomised trial. The various summary measures of non-invasive ventilation use we will explore will more clearly inform future statistical power calculations.

Changes in carer burden, daytime sleepiness, generic and disease-specific quality of life will be explored using paired t-tests and linear models as appropriate. Thematic analysis will be performed for qualitative semi-structured interviews.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 16603 0
Austin Health - Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 30200 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 305643 0
Charities/Societies/Foundations
Name [1] 305643 0
Motor Neurone Disease Research Australia
Address [1] 305643 0
2 Phipps Cl
Deakin
ACT 2600
Country [1] 305643 0
Australia
Funding source category [2] 305647 0
University
Name [2] 305647 0
Melbourne Disability Institute. The University of Melbourne
Address [2] 305647 0
Melbourne Disability Institute
The University of Melbourne
Victoria 3010
Country [2] 305647 0
Australia
Primary sponsor type
Hospital
Name
Austin Health
Address
145 Studley Road
Heidelberg
Victoria 3084
Country
Australia
Secondary sponsor category [1] 306053 0
None
Name [1] 306053 0
Address [1] 306053 0
Country [1] 306053 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305929 0
Austin Health Human Research Ethics Committee (HREC)
Ethics committee address [1] 305929 0
Level 8 Harold Stokes Building, Office for Research
Austin Health
145 Studley Road
PO Box 5555 Heidelberg
Victoria 3084
Ethics committee country [1] 305929 0
Australia
Date submitted for ethics approval [1] 305929 0
25/02/2020
Approval date [1] 305929 0
07/05/2020
Ethics approval number [1] 305929 0

Summary
Brief summary
For people with sleep and breathing problems, wearing a breathing machine and mask (non-invasive ventilation, NIV) when sleeping makes them less sleepy during the day and helps them have a better quality of life. Our team led research showing that using NIV when sleeping reduces the rate of decline in breathing function and can improve the life expectancy in people with Motor Neurone Disease. Motor Neurone Disease (MND) is a rare progressive terminal neurological disease with an average life expectancy of two to five years. The benefits of NIV are relatively largest in MND, but it is believed that all people who need NIV will benefit from its’ use. For patients to receive the greatest benefit from NIV, it is recommended the breathing machine and mask are worn for more than four hours a night.

Currently, people with sleep and breathing problems referred to the Victorian Respiratory Support Service are set up with a breathing machine and mask during an admission to the Austin Hospital. These admissions can be burdensome and time consuming for patients, their families and carers. An ever-increasing demand for inpatient beds can also further delay access to NIV and increase burden and anxiety. Once on NIV, troubleshooting usually involves going to the hospital or a nurse from the Victorian Respiratory Support Service Outreach nursing team visiting the patient’s home. Additionally, in light of the coronavirus pandemic (COVD-19), research studies investigating alternative models of care that do not require patients to visit the hospital (telehealth) are needed.

In this study we will allocate people to one of two groups (50/50 chance) and each group will receive a different model of care: 1) current model of care (usual care) which involves starting non-invasive ventilation at Austin Hospital or 2) NIV@Home (intervention) which involves starting non-invasive ventilation at home with follow up phone calls from a physiotherapist. We will compare the results to see if the NIV@Home model of care results in similar non-invasive ventilation use.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 102102 0
Prof David Berlowitz
Address 102102 0
Level 3 Harold Stokes Building, Physiotherapy Administration
Austin Health
145 Studley Road
Heidelberg
Victoria 3084
Country 102102 0
Australia
Phone 102102 0
+61 3 9496 3070
Fax 102102 0
Email 102102 0
david.berlowitz@austin.org.au
Contact person for public queries
Name 102103 0
Prof David Berlowitz
Address 102103 0
Level 3 Harold Stokes Building, Physiotherapy Administration
Austin Health
145 Studley Road
Heidelberg
Victoria 3084
Country 102103 0
Australia
Phone 102103 0
+61 3 9496 3070
Fax 102103 0
Email 102103 0
david.berlowitz@austin.org.au
Contact person for scientific queries
Name 102104 0
Prof David Berlowitz
Address 102104 0
Level 3 Harold Stokes Building, Physiotherapy Administration
Austin Health
145 Studley Road
Heidelberg
Victoria 3084
Country 102104 0
Australia
Phone 102104 0
+61 3 9496 3070
Fax 102104 0
Email 102104 0
david.berlowitz@austin.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Anonymised individual participant data that underlie the results reported in publications.
When will data be available (start and end dates)?
Beginning nine months following publication with no end date.
Available to whom?
Proposals to analyse individual participant data will be directed to the Principal Investigator Professor David Berlowitz. Investigators whose proposed use of the individual participant data has been approved by an independent review committee will be eligible to request individual participant data. Data requesters will need to sign a data access agreement.
Available for what types of analyses?
Subject to optional consent, where participants give permission for data to be used for the purpose of:
1. This ethically approved research project only.
2. This ethically approved research project and any closely related future research projects.
3. This ethically approved research project and any future research projects that may or may not be related to this project.
How or where can data be obtained?
Proposals to analyse individual participant data will be directed to the Principal Investigator Professor David Berlowitz. david.berlowitz@austin.org.au
What supporting documents are/will be available?
No other documents available
Summary results
No Results