Developing and testing a toolkit of interventions to improve adherence to non-invasive ventilation in children: a mixed methods study (The SPIRITUS study)

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN56845190

Enrollment

Registered

2024-01-22

Start date

2023-07-03

Completion date

Unknown

Last updated

2025-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep disordered breathing in children and young children Respiratory

Interventions

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 equipmen

Eligibility

Sex/Gender

All

Inclusion criteria

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)

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Delivery of Phase 3 of the study: 1. Feasibility is measured by fidelity to study design and procedures, including any adaptations made during the study period 2. Acceptability is measured by the invitation and response and retention rates: 2.1. Invitation rate: recorded as the number of potentially eligible participants invited to participate in the study during the recruitment period 2.2. Response rate: recorded as the number of eligible participants who consent to participate during the recruitment period. 2.3. Retention rates: recorded as the number of eligible participants who consent to participate, engage in a clinical session in which they choose an intervention from the toolkit, test the intervention for a period of 2 weeks and take part in at least one debrief activity with the researcher at the end of the intervention	—

Measure

Time frame

Delivery of Phase 3 of the study: 1. Feasibility is measured by fidelity to study design and procedures, including any adaptations made during the study period 2. Acceptability is measured by the invitation and response and retention rates: 2.1. Invitation rate: recorded as the number of potentially eligible participants invited to participate in the study during the recruitment period 2.2. Response rate: recorded as the number of eligible participants who consent to participate during the recruitment period. 2.3. Retention rates: recorded as the number of eligible participants who consent to participate, engage in a clinical session in which they choose an intervention from the toolkit, test the intervention for a period of 2 weeks and take part in at least one debrief activity with the researcher at the end of the intervention

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Secondary

Measure	Time frame
1. Feasibility of toolkit components measured by parent and child self-report post-intervention 2. Acceptability of toolkit components measured by: 2.1. Uptake of toolkit components by families during the study period 2.2. Retention rate: recorded as the number of eligible participants who test the intervention for a period of 2 weeks and take part in at least one debrief activity with the researcher at the end of the intervention	—

Measure

Time frame

1. Feasibility of toolkit components measured by parent and child self-report post-intervention 2. Acceptability of toolkit components measured by: 2.1. Uptake of toolkit components by families during the study period 2.2. Retention rate: recorded as the number of eligible participants who test the intervention for a period of 2 weeks and take part in at least one debrief activity with the researcher at the end of the intervention

—

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 5, 2026