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Paediatric Palliative CareSPhAERANCT04236180

Effectiveness of Specialised Paediatric Palliative Care

A study testing Specialised Paediatric Palliative Care (SPPC) in people with Paediatric Palliative Care, run by University Children's Hospital, Zurich at 4 sites in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study evaluates the effectiveness of an existing Specialised Paediatric Palliative Care programme and reports on its potential to improve patient-, family-, health professionals-, and healthcare-related outcomes. Data will be compared between an intervention and a comparison group. Read more about this study

Who is it for?
Ages Up to 18 years
Conditions the study is for
Paediatric Palliative Care
What is being tested?
Specialised Paediatric Palliative Care (SPPC)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
4 sitesSwitzerland
Study dates
5 Nov 2019to 31 May 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Children, aged 0-18 years, suffering from a life-limiting condition of various origins and potentially in need of SPPC (for Zurich, additionally enrolment in the SPPC programme)
  • Parents (mothers and fathers) of included children
  • Siblings, aged >8 years, of included families
  • All health care professionals involved in the care of included families
  • Proficiency in French or German language
  • Signed Informed Consent after being informed

Who cannot join

  • Neonates with medical complications due to prematurity and/or birth complications and treated in a neonatal intensive care unit
  • Children with an estimated life expectancy of <48 hours

Trial locations and contacts

4 sites in 1 country.

Switzerland4 sites

  • Cantonal Children's Hospital

    Aarau

  • University Children's Hospital

    Basel

  • Department of Pediatrics, University Hospital Inselspital

    Bern

  • University Children's Hospital Zurich

    Zurich, 8032

Other trials in Switzerland

About this study

Official title: Specialised Paediatric Palliative Care: Assessing Family, Healthcare Professionals and Health System Outcomes in a Multi-site Context of Various Care Settings

This study evaluates the effectiveness of an existing Specialised Paediatric Palliative Care programme and reports on its potential to improve patient-, family-, health professionals-, and healthcare-related outcomes. Data will be compared between an intervention and a comparison group.

Read the detailed description

The number of children and adolescents living with life-limiting conditions and potentially in need for specialised paediatric palliative care (SPPC) is rising. As a highly complex subfield of palliative care, paediatric palliative care focuses on the support and involvement of the entire family, and on the impact not only at the patient level, but also at the family and health systems level. Ideally, a specialised multiprofessional team fills the complex healthcare needs of children and their families. A consultative care model might be well-suited to address each family's most important needs. The question, however, of how SPPC is beneficial for whom and under what circumstances remain largely unanswered as validation of innovative care programmes in controlled studies is lacking.

This study's overall target is to evaluate the effectiveness of SPPC and to report on its potential to improve patient-, family-, health professional-, and healthcare-related outcomes. The primary objective is to explore how SPPC influences the quality of life (QOL) of caregivers, i.e. parents. Secondary objectives are to explore how SPPC influences the QOL of patients including their symptom severity and distress as well as the QOL of their siblings and of healthcare professionals not specialised in PPC. Further objectives are to determine whether the provision of SPPC reduces the utilisation of healthcare resources and direct and indirect health-related costs for families, and to evaluate implementation outcomes such as adoption, i.e., the uptake of SPPC.

This interventional multi-centre study will apply a hybrid design to determine the clinical effectiveness (comparative effectiveness research) of an existing SPPC programme, while gathering information on its delivery and potential implementation in a real-life situation.

This study will be conducted in compliance with the protocol, the current version of the Declaration of Helsinki, the ICH-GCP as well as all national legal and regulatory requirements.

Being tested
Specialised Paediatric Palliative Care (SPPC)
Keywords
Paediatrics, Palliative Care

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Specialised Paediatric Palliative Care (SPPC)Other

    All services provided to children/families by a member of the multiprofessional SPPC team in Zurich according to local guidelines will be considered as study intervention. This includes direct consultation of the patient/family, as well as patient-/family-related consultation of the frontline care team. Bereavement support is considered an integrated part of SPPC and after the death of a child, follow-up bereavement support is routinely offered at the individual or group level as appropriate for parents and siblings.

Study groups in NCT04236180
Study groupRoleWhat they receive
Intervention GroupActive comparatorPatients enrolled in the Specialised Paediatric Palliative Care (SPPC) programme at the University Children's Hospital Zurich.
Receives: Other: Specialised Paediatric Palliative Care (SPPC)
Comparison GroupNo interventionPatients treated at the Children's Hospital Aarau, University Children's Hospital Basel, and the University Hospital Inselspital Bern.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Caregiver QOL - QOLLTI-F Questionnaire

    Longitudinal assessment of self-reported caregiver (parental) Quality of Life (QOL) using the QOLLTI-F (Quality of Life in Life Threatening Illness - Family Carer Version) questionnaire.

    Measured: Up to day 330 after study entry

Secondary outcomes (7)

  1. Change in Child's QOL - DISABKIDS Chronic Generic Measure (DCGM-37) Questionnaire

    Longitudinal assessment of child's Quality of Life using the DCGM-37 DISABKIDS questionnaire.

    Measured: Up to day 330 after study entry

  2. Change in child's symptoms - Memorial Symptom Assessment Scale (MSAS) Questionnaire

    Longitudinal assessment of child's symptoms by using the Memorial Symptom Assessment Scale (MSAS) questionnaire. MSAS assesses severity, frequency and distress for symptom evaluation using separate 4 or 5 point Likert scales. Higher values are associated with higher symptom burden.

    Measured: Up to day 330 after study entry

  3. Change in Siblings QOL - KIDSSCREEN-27 Questionnaire

    Longitudinal assessment of sibling's health related Quality of Life using the KIDSSCREEN-27 questionnaire.

    Measured: Up to day 630 after study entry

  4. Professional's QOL (ProQOL) Questionnaire

    Assessing self-reported healthcare professional's Quality of Life using the ProQOL questionnaire.

    Measured: Cross-sectional at the end of study year 1

  5. Professional's QOL (ProQOL) Questionnaire

    Assessing self-reported healthcare professional's Quality of Life using the ProQOL questionnaire.

    Measured: Cross-sectional at the end of study year 2

  6. Chang in grief - "Würzburger Trauerinventar (WüTi)" Questionnaire

    Longitudinal assessment of parental grief processes using the "Würzburger Trauerinventar (WüTi)" questionnaire.

    Measured: Up to 1 year after the child's death

  7. Change in parental QOL during bereavement - WHOQOL-BREF Questionnaire

    Longitudinal assessment of parental Quality of Life during bereavement using the WHO Quality of Life-BREF questionnaire.

    Measured: Up to 1 year after the child's death

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jan 2020
  2. Study start5 Nov 2019
  3. Primary completion31 May 2023
  4. Study completion31 May 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Interventional multi-centre study with a hybrid design to determine the clinical effectiveness (comparative effectiveness research) of an existing SPPC programme, while gathering information on its delivery and potential implementation in a real-life situation
Masking
None (open label)
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04236180
Sponsor's protocol ID
2019-INV-001
Acronym
SPhAERA
Status last verified
Dec 2023
First submitted
15 Mar 2019
Last updated
15 Dec 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Mitterer S, Zimmermann K, Fink G, Simon M, Gerber AK, Bergstrasser E. Hospitalization- and death-related financial and employment effects in parents of children with life-limiting conditions: a fixed-effects analysis. Eur J Pediatr. 2024 Oct;183(10):4215-4227. doi: 10.1007/s00431-024-05680-7. Epub 2024 Jul 10.

    PubMed 38985175

  • Gerber AK, Feuz U, Zimmermann K, Mitterer S, Simon M, von der Weid N, Bergstrasser E. Work-related quality of life in professionals involved in pediatric palliative care: a repeated cross-sectional comparative effectiveness study. Palliat Care Soc Pract. 2024 May 9;18:26323524241247857. doi: 10.1177/26323524241247857. eCollection 2024.

    PubMed 38737405

  • Zimmermann K, Simon M, Scheinemann K, Tinner Oehler EM, Widler M, Keller S, Fink G, Mitterer S, Gerber AK, von Felten S, Bergstraesser E. Specialised Paediatric PAlliativE CaRe: Assessing family, healthcare professionals and health system outcomes in a multi-site context of various care settings: SPhAERA study protocol. BMC Palliat Care. 2022 Nov 2;21(1):188. doi: 10.1186/s12904-022-01089-x.

    PubMed 36324132

Questions about this trial

What is this clinical trial studying?

A study testing Specialised Paediatric Palliative Care (SPPC) in people with Paediatric Palliative Care, run by University Children's Hospital, Zurich at 4 sites in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Caregiver QOL - QOLLTI-F Questionnaire (time frame: Up to day 330 after study entry). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04236180, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2023.

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