The SPIRITUS study
Research type
Research Study
Full title
Developing and testing a toolkit of interventions to improve adherence to non-invasive ventilation in children: a mixed methods study (The SPIRITUS study)
IRAS ID
325870
Contact name
Jessica Russell
Contact email
Sponsor organisation
Great Ormond Street Hospital NHS Foundation Trust
Duration of Study in the UK
2 years, 9 months, 15 days
Research summary
Why
Children and young people (CYP) with breathing difficulties during sleep, known as sleep disordered breathing (SDB), can suffer from hyperactivity and/or lack of energy, poor concentration, repeated admissions for respiratory infections and poor growth and development.
NIV is a method of helping children’s breathing via a face mask over their nose and/or mouth and breathing machine. It can have positive short and long-term effects on the child’s health, behaviour and school participation (called outcomes). However, it can be uncomfortable and cause facial skin damage and other problems.
What
We aim to:
-produce a toolkit of interventions that address the barriers to NIV use.
-discover what outcomes from NIV are important to CYP and parents.
Where: Great Ormond Street Hospital
When: Jan 2023-October 2025
How:
Phase 1: We will look at all the previous NIV studies on ways to help families and outcomes. We will host online/in person workshops, (8-12 parents, 8-12 CYP, 8-10 HCPs and NIV equipment industries representatives). We will share our previous study findings and others’ research and ask what interventions and outcomes we should test.
Phase 2: We will look at all the research on these interventions and outcomes. We will host further workshops to finalise a list of outcomes and interventions.
Phase 3: 10-12 CYP and parents will choose and test an intervention and outcome for 2 weeks to see if they are practical and acceptable. Parents will keep a diary and CYP will wear an Actiwatch. Afterwards, parents and CYP will talk about their experience. Data will be collected from the ventilator and questionnaires completed before and afterwards.
PPI
Our Study Steering Group provide feedback on the accessibility, practicality and sensitivity of our approach and methods.
Dissemination
We will share our findings with other researchers CYP, families and HCPs using a range of media.REC name
West Midlands - Solihull Research Ethics Committee
REC reference
23/WM/0102
Date of REC Opinion
22 May 2023
REC opinion
Favourable Opinion