NIV@Home Pilot Randomised Controlled Trial Dataset
The University of MelbourneDataset description
This dataset contains de identified participant level data from the NIV@Home pilot randomised controlled trial, which compared in home noninvasive ventilation (NIV) initiation with remote follow up against a single day hospital admission NIV initiation model in adults with neuromuscular disease, predominantly motor neurone disease (MND). The trial assessed feasibility, adherence to NIV over 12 weeks, health related quality of life, symptoms, carer burden, and participants' experiences of NIV initiation. Recruitment occurred between August 2020 and August 2021 during the COVID 19 pandemic, which influenced referral patterns, follow up, and hospital access. The dataset includes demographics, respiratory function, comorbidities, baseline assessments, randomisation strata, NIV settings, usage data (objective ventilator downloads), follow up contact logs, qualitative interview summaries, and outcome measures evaluating feasibility and adherence. The dataset supports evaluation of alternative models of NIV initiation and contributes to the evidence base for home based respiratory care in neuromuscular disease. Publication DOI: 10.1080/21678421.2024.2416668Date Information
Source Study
Trial name (public)
Purpose:
Phase:
Trial acronym
Not available
Trial ID
ACTRN12620000682943
Funding
Charities/Societies/Foundations, Motor Neurone Disease Research Australia
Scientific enquiries
Prof David Berlowitz
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 exp .... Read more
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.
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.
Can healthy volunteers participate?
No
Population
Sample Size 23
Min. age 18 Years
Max. age No limit
Sex Both males and females
Condition category Motor Neurone Disease , Other disorders with, or at imminent risk of, chronic hypercapnic ventilatory failure
Condition code Respiratory , Neurological
Intervention
Intervention code Treatment: Other
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 .... Read more
Comparison
Control group Active
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 eq .... Read more
Outcomes
Outcome: 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: During the 12-week trial period.
Will the study consider sharing individual participant data?
Yes
Who can request access to individual participant data?
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.
Are there any conditions for requesting access to individual participant data?
-
What individual participant data might be shared?
Individual participant data not covered above
Anonymised individual participant data that underlie the results reported in publications.
What types of analyses could be done with individual participant data?
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.
Are there extra considerations when requesting access to individual participant data?
No
When can requests for individual data be made (start and end dates)?
From: Beginning nine months following publication with no end date.
To: -