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Validation of the Clinical Decision Support Systems (CDSS) Developed in the EU Horizon PREPARE Project in the Rehabilitative Treatment of Idiopathic Scoliosis

NCT07379593 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 178

Last updated 2026-01-30

No results posted yet for this study

Summary

The study aims to validate both the predictive capacity and the clinical usability of the Clinical Decision Support System (CDSS) developed within the PREPARE project (European Union Grant Agreement 101080288 PREPARE HORIZON-HLTH-2022-TOOL-12-01) for the management of idiopathic scoliosis (IS). This will be achieved through simulation-based studies.

Conditions

  • Adolescent Idiopathic Scoliosis (AIS)

Interventions

OTHER

CDSS simulation

The intervention planned in this study consists of a simulation, carried out by physicians, of the use of a Clinical Decision Support System (CDSS) designed to support informed decision-making in prescribing rehabilitative treatment for idiopathic scoliosis (IS). Physicians will continue their routine clinical practice and will subsequently be exposed to the CDSS results for the same cases they had previously assessed, after a three-month interval (the typical period between a visit and a follow-up). This delay is intended to minimize recall bias and to ensure that exposure to the CDSS does not retrospectively influence their therapeutic decisions, thereby avoiding any interference with their daily clinical activity. The study will simulate the integration of the CDSS into the clinicians' routine workflow. The CDSS will be developed based on advanced computational models using artificial intelligence, specifically adapted to the rehabilitation context for IS, and created during the f

OTHER

Focus group - clinicians

Focus group aimed at exploring how the implementation of the CDSS has influenced the clinical practice of physicians who previously simulated its integration into their professional activity, as well as their decision-making processes and approaches to patient care.

OTHER

Focus group - patients

Two separate focus groups will be organized: one for patients and one for parents. During the sessions, hypothetical clinical scenarios involving the use of CDSS in their care pathway will be presented. The scenarios will be identical for both groups. Participants will be encouraged to share their opinions, thoughts, and feelings regarding CDSS. Facilitators will guide the discussion, ensuring that all participants have the opportunity to express their views and that diverse perspectives are collected.

Sponsors & Collaborators

  • Istituto Scientifico Italiano Colonna Vertebrale

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
10 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-11-07
Primary Completion
2027-03-01
Completion
2027-05-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07379593 on ClinicalTrials.gov