Developing and testing a toolkit of interventions to improve adherence to non-invasive ventilation in children: a mixed methods study (The SPIRITUS study)
| ISRCTN | ISRCTN56845190 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN56845190 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 325870 |
| Protocol serial number | IRAS 325870, CPMS 56256 |
| Sponsor | Great Ormond Street Hospital for Children NHS Foundation Trust |
| Funder | National Institute for Health and Care Research |
- Submission date
- 26/09/2023
- Registration date
- 22/01/2024
- Last edited
- 02/12/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Plain English summary of protocol
Background and study aims
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 a 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. The aim of this study is to produce a toolkit of interventions that address the barriers to NIV use and discover what outcomes from NIV are important to CYP and parents.
Who can participate?
Children and young people (aged 0-18 years) who have been diagnosed with sleep-disordered breathing, are being treated by the study site and have used NIV for more than 3 months, their parents and staff at the study site who provide care for patients who use NIV.
What does the study involve?
Phase 1: The researchers will look at all the previous NIV studies on ways to help families and outcomes. They will host online/in-person workshops (8-12 parents, 8-12 CYP, 8-10 HCPs and NIV equipment industries representatives). The researchers will share their previous study findings and others’ research and ask what interventions and outcomes they should test.
Phase 2: The researchers will look at all the research on these interventions and outcomes. They 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.
What are the possible benefits and risks of participating?
There are no direct benefits to taking part but it is hoped that participants will find it worthwhile to help the scientific community to understand more about potential ways to help children use NIV. Taking part will mean participants giving up some time. Although the researchers do not think that participating in discussions will be distressing, should any participant become upset and want to talk to someone the researchers can arrange that for them.
Where is the study run from?
Great Ormond Street Hospital for Children NHS Foundation Trust (UK)
When is the study starting and how long is it expected to run for?
January 2023 to October 2025
Who is funding the study?
National Institute for Health and Care Research (NIHR) (UK)
Who is the main contact?
Jessica Russell, jessica.russell@gosh.nhs.uk
Contact information
Principal investigator
Great Ormond Street Hospital NHS Foundation Trust
Barclay House
37 Queen Square
London
WC1N 3BH
United Kingdom
 ORCID ID |
0000-0003-3194-412X |
|---|---|
| Phone | +44 (0)7716111173 |
| jessica.russell@gosh.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Mixed methods feasibility acceptability study |
| Secondary study design | Mixed methods feasibility acceptability study |
| Study type | Participant information sheet |
| Scientific title | Developing and testing a toolkit of interventions to improve adherence to non-invasive ventilation in children: a mixed methods study (The SPIRITUS study) |
| Study acronym | SPIRITUS |
| Study objectives | This study aims to identify and assess for feasibility and acceptability the components of a toolkit of interventions to address some of the barriers to adherence of non-invasive ventilation for sleep disordered breathing in children and young people. |
| Ethics approval(s) |
Approved 05/06/2023, The West Midlands - Solihull Research Ethics Committee (Equinox House, City Link, East Midlands REC Centre, Nottingham, NG2 4LA, United Kingdom; +44 (0)207 1048191; solihull.rec@hra.nhs.uk), ref: 23/EM/0102 |
| Health condition(s) or problem(s) studied | Sleep disordered breathing in children and young children |
| Intervention | Phase 1: The researchers will look at all the previous NIV studies on ways to help families and outcomes. They will host online/in-person workshops, (8-12 parents, 8-12 CYP, 8-10 HCPs and NIV equipment industries representatives). They will share their previous study findings and others’ research and ask what interventions and outcomes they should test. Phase 2: The researchers will look at all the research on these interventions and outcomes. They will host further workshops to finalise a list of outcomes and interventions. Phase 3: Phase 3 will comprise a toolkit of interventions to address some of the barriers to adherence to non-invasive ventilation. 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. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
Delivery of Phase 3 of the study: |
| Key secondary outcome measure(s) |
1. Feasibility of toolkit components measured by parent and child self-report post-intervention |
| Completion date | 25/10/2025 |
Eligibility
| Participant type(s) | Patient, Employee, Other |
|---|---|
| Age group | Child |
| Lower age limit | 0 Years |
| Upper age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 46 |
| Key inclusion criteria | Phases 1, 2 and 3: Children and young people: 1. Age 0-18 years 2. Diagnosis of sleep disordered breathing 3. Have been prescribed NIV >3 months prior to recruitment 4. Under the care of the study site NIV team Parents and carers: 1. Parents/carers (adults with parental responsibility) of the above children Staff 1. Study site staff who provide NIV care (medical, nursing, allied health professionals, health care assistants, sleep-unit technicians, physiologists) |
| Key exclusion criteria | Phases 1 and 2: 1. Children and young people 2. Medically dependent on NIV 3. Receiving NIV for palliation 4. Use of NIV for <3 months 5. Weaning off NIV Parents: Parent members of the SPIRITUS Study Steering Group Staff: Study Site staff who do not work in Study Site NIV service Phase 3: Children and young people: 1. Medically dependent on NIV 2. Receiving NIV for palliation 3. Use of NIV for <3 months 4. Weaning off using NIV Parents and carers: 1. Parents who do not consent for their child’s participation (even if they consent for their own) 2. Parents of children who do not want to take part 3. Parents in the PPI Study Steering Group 4. Parents who took part in Phases 1 and 2 5. Any families involved in intervention development (either PPI activities or the creation of the intervention e.g. a video) 6. Parents who have already tested one intervention |
| Date of first enrolment | 03/07/2023 |
| Date of final enrolment | 30/09/2023 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
London
WC1N 3JH
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan | Data from the study will not be made available: the participants of this study did not give written consent for their data to be shared publicly, so due to the sensitive nature of the research supporting data are not available. All paper data will be stored in a locked filing cabinet, which is located in a research office at Great Ormond Street Hospital only accessible by a swipe card. Personal identifiable data and consent forms will be stored separately from research data. Electronic data (such as audio recordings and Zoom/MS Teams recordings) is stored on password-protected servers accessed by Trust devices. At the end of the study personal data will only be stored and accessed for up to 6 months. Research data will be stored for 20 years or in accordance with GOSH Trust policies. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 28/11/2024 | 02/12/2024 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
02/12/2024: Publication reference added.
07/02/2024: Internal review.
17/10/2023: Study's existence confirmed by the NIHR.
