Transmural Care for Chronically Ill Children: Scientific Guidance and Evaluation of Pilot Projects

NCT ID: NCT06679595

Last Updated: 2024-11-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-09-10

Study Completion Date

2026-02-28

Brief Summary

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The goal of this Realist Evaluation is to evaluate the implementation of pilot projects for transmural care in chronically ill children.

The main question it aims to answer is: To what extent and how do the pilot projects for transmural care for chronically ill children provide an answer to the quintuple aim?

Participants will

* Complete questionnaires at three timepoints
* Participate in focus group interviews

Detailed Description

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Introduction Chronic diseases have been increasing over the past few years, including in children. The chronic condition affects their daily functioning and quality of life and leads to frequent hospital admissions. To avoid unneccessary hospital admissions and to offer alternative and innovative forms of care, the Belgian Federal Public Service of Public Health, Food Chain Safety and Environment selected five pilot projects for transmural care for chronically ill children. This study was designed to evaluate these projects.

Methods and design The overall approach is a two-year longitudinal prospective Realist Evaluation using a mixed-methods design.

The quantitative strand, using routine data and questionnaires, will examine whether data from children, parents/legal guardians and healthcare professionals involved in a pilot project for paediatric transmural care comply with the quintuple aim outcomes.

The qualitative strand will be used (1) to evaluate the structure of the interventions, (2) for process evaluation and context analysis, and (3) to gather more in-depth information. This includes document analysis (including logbooks), focus groups with children, parents/legal guardians and healthcare professionals, and non-participatory observations.

Ethical Informed consent is required prior to inclusion in the evaluation study. Informed assent is requested from children older than 12 years. For this study, advice is asked from the Research Ethics Committee of Ghent University Hospital

Conditions

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Chronic Diseases in Children Chronic Diseases in Adolescence Health Personnel Parents

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Children

Children up to the age of 18 with a chronic condition included in a pilot project for paediatric transmural care

Pilot project paediatric transmural care

Intervention Type OTHER

The implementation of pilot projects for transmural care for chronically ill children

Parents

Parents/ legal guardians of children included in a pilot project for paediatric transmural care

Pilot project paediatric transmural care

Intervention Type OTHER

The implementation of pilot projects for transmural care for chronically ill children

Healthcare professionals

Project coordinators and healtcare professionals involved in a pilot project for paediatric transmural care

Pilot project paediatric transmural care

Intervention Type OTHER

The implementation of pilot projects for transmural care for chronically ill children

Interventions

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Pilot project paediatric transmural care

The implementation of pilot projects for transmural care for chronically ill children

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Children: any child up to the age of 18 participating in a pilot project for paediatric transmural care.
* Parent/Legal guardian: any parent or legal guardian of a child participating in a pilot project for paediatric transmural care
* Healthcare professionals: any healthcare professional with patient contact involved within a pilot project for paediatric transmural care
* Coordinators: all study and care coordinators involved within a pilot project for paediatric transmural care

Exclusion Criteria

* No signed informed consent form available
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Centre Hospitalier Regional de la Citadelle

UNKNOWN

Sponsor Role collaborator

Centre Hospitalier Jolimont-Lobbes

UNKNOWN

Sponsor Role collaborator

University Hospital, Antwerp

OTHER

Sponsor Role collaborator

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role collaborator

Centre Hospitalier Universitaire de Liege

OTHER

Sponsor Role collaborator

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

OTHER

Sponsor Role collaborator

Universitair Ziekenhuis Brussel

OTHER

Sponsor Role collaborator

Institut de Pathologie et de Génétique Charleroi

OTHER

Sponsor Role collaborator

CHC Montlegia

OTHER

Sponsor Role collaborator

Hôpital universitaire des enfant Reine Fabiola

UNKNOWN

Sponsor Role collaborator

University Hospital, Ghent

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sabine Van daele, Prof. dr.

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Ghent

Veerle Duprez, dr.

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Ghent

Locations

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Hôpital universitaire des enfants Reine Fabiola

Brussels, , Belgium

Site Status

Cliniques Universitaires Saint-Luc

Brussels, , Belgium

Site Status

Institut de Pathologie et de Génétique Charleroi

Charleroi, , Belgium

Site Status

University Hospital Antwerp

Edegem, , Belgium

Site Status

Universitair Ziekenhuis Gent

Ghent, , Belgium

Site Status

Universitair Ziekenhuis Brussel

Jette, , Belgium

Site Status

Centre Hospitalier Jolimont-Lobbes

La Louvière, , Belgium

Site Status

Universitaire Ziekenhuizen Leuven

Leuven, , Belgium

Site Status

Centre Hospitalier Régional de la Citadelle

Liège, , Belgium

Site Status

Centre Hospitaliere Universitaire de Liège

Liège, , Belgium

Site Status

Clinique CHC MontLégia

Liège, , Belgium

Site Status

Countries

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Belgium

References

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Dequeker S, Vanderwee K, Van Daele S, Duprez V; PETRACA Study Group. Realist evaluation of Belgian pilot projects for paediatric transmural care: protocol for a mixed methods study. BMJ Open. 2025 Jun 25;15(6):e102152. doi: 10.1136/bmjopen-2025-102152.

Reference Type DERIVED
PMID: 40562551 (View on PubMed)

Other Identifiers

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B670204000193

Identifier Type: -

Identifier Source: org_study_id

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