NCT07801911

Brief Summary

Children with complex care needs often experience fragmented care during transitions from hospital to home, leading to unmet needs and increased burden on families. The SPARKLe project aims to address this gap through a nurse-led integrated transitional care model. This study evaluates the feasibility of implementing the SPARKLe model in a real-world hospital setting using a mixed-methods design, focusing on implementation outcomes including feasibility, acceptability, adoption, and fidelity.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

April 16, 2026

Completed
5 months until next milestone

First Posted

Study publicly available on registry

September 3, 2026

Completed
Last Updated

September 3, 2026

Status Verified

April 1, 2026

Enrollment Period

4 months

First QC Date

April 16, 2026

Last Update Submit

August 31, 2026

Conditions

Keywords

SPARKLeChildren with complex care needsIntegrated CareTranisitional CareImplementationCare CoordinationFeasibility Study

Outcome Measures

Primary Outcomes (1)

  • Feasibility of the SPARKLe care model among community providers

    Feasibility of the SPARKLe care model from the perspective of community providers was assessed using four survey items adapted from the Feasibility of Intervention Measure (FIM), together with selected items informed by the Normalization Measure Development (NoMAD) instrument. NoMAD-informed items assessed coherence, cognitive participation, and collective action related to implementation and integration of the SPARKLe care model into routine practice. Survey items were rated on a five-point Likert scale ranging from strongly disagree to strongly agree.

    Approximately 2-3 weeks after hospital discharge.

Secondary Outcomes (6)

  • Qualitative perceptions of feasibility of the SPARKLe care model

    During the 4-month feasibility evaluation period, with family caregiver interviews conducted approximately 2 weeks after hospital discharge.

  • Acceptability of the SPARKLe care model among community providers

    Approximately 2-3 weeks after hospital discharge

  • Qualitative perceptions of acceptability of the SPARKLe care model

    During the 4-month feasibility evaluation period, with family caregiver interviews conducted approximately 2 weeks after hospital discharge.

  • Early adoption of the SPARKLe care model assessed through healthcare professional focus group interviews

    During the 4-month implementation period

  • Proportion of SPARKLe intervention components implemented as intended

    From hospital admission through 48 hours after discharge

  • +1 more secondary outcomes

Study Arms (1)

SPARKLe intervention

EXPERIMENTAL

Participants receive the SPARKLe nurse-led integrated transitional care model designed to improve coordination and continuity of care for children with complex care needs during the transition from hospital to home.

Behavioral: SPARKLe model

Interventions

SPARKLe modelBEHAVIORAL

The SPARKLe model is a nurse-led integrated transitional care intervention for children with complex care needs. It includes key components such as early identification of eligible patients, structured needs assessment, active family engagement, standardized information transfer, and coordination of follow-up care across healthcare settings.

SPARKLe intervention

Eligibility Criteria

Age0 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children aged 0 to 16 years with complex care needs
  • Admitted to a general pediatric unit at the University Children's Hospital Zurich for more than 24 hours
  • Families of eligible children willing to participate in study procedures
  • Hospital healthcare professionals involved in the care of included children
  • Community healthcare providers involved in post-discharge care of included children

You may not qualify if:

  • Children receiving care within an already established specialized care program at the hospital (e.g., palliative care or oncology care programs) Families declining participation Hospital professionals not directly involved in the care of included children Community providers not involved in the child's post-discharge care

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Children's Hospital Zurich

Zurich, 8008, Switzerland

Location

MeSH Terms

Conditions

Chronic Disease

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Suzanne Dhaini, PhD, RN

    University Children's Hospital, Zurich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: This is a single-group feasibility study in which all participants receive the SPARKLe nurse-led integrated transitional care model. The study evaluates the implementation of the model in a real-world hospital setting without a comparison group.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 16, 2026

First Posted

September 3, 2026

Study Start

April 1, 2024

Primary Completion

July 31, 2024

Study Completion

December 31, 2024

Last Updated

September 3, 2026

Record last verified: 2026-04

Locations