Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-30 @ 3:56 AM
Study NCT ID:
NCT07379593
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2026-01-30
First Post:
2026-01-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation of the Clinical Decision Support Systems (CDSS) Developed in the EU Horizon PREPARE Project in the Rehabilitative Treatment of Idiopathic Scoliosis
Sponsor:
Istituto Scientifico Italiano Colonna Vertebrale
Organization:
Study Overview
Official Title:
Validation of the Clinical Decision Support Systems (CDSS) Developed in the EU Horizon PREPARE Project in the Rehabilitative Treatment of Idiopathic Scoliosis
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2026-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PREPARE
Brief 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.
Detailed Description:
Study Population:
Three participant groups will be included:
* Patients under 18 years who have undergone rehabilitative treatment for idiopathic scoliosis at ISICO's main center in Milan.
* Parents of the included patients.
* Specialist physicians in rehabilitation involved in scoliosis management at ISICO.
All participants must have adequate cognitive and language abilities to take part in discussions and complete questionnaires.
Sample Size:
Part I: Involves the 8 ISICO physicians performing clinical visits.
The main outcome measure is the variation in treatment decisions before and after exposure to the CDSS.
With α = 0.05, power = 80%, and expected effect size (Cohen's d = 0.3), the minimum required sample size is 175 clinical cases.
Parts II-III (Focus Groups):
6-12 patients
6-12 parents
6-10 physicians These group sizes align with qualitative research standards to ensure thematic saturation.
Safety Evaluation:
Adverse events will be monitored, recorded, and assessed by the Data Safety Monitoring Committee (DSMC).
Statistical and Analytical Plan:
Quantitative analysis will evaluate:
The frequency, nature, and motivations behind changes in treatment plans after using CDSS recommendations.
Correlations between CDSS suggestions and clinicians' treatment decisions.
Qualitative analysis will interpret data from focus group discussions to identify patterns, trends, and associations between CDSS recommendations, clinical choices, and possible alternative decisions had the CDSS been applied.
Three participant groups will be included:
* Patients under 18 years who have undergone rehabilitative treatment for idiopathic scoliosis at ISICO's main center in Milan.
* Parents of the included patients.
* Specialist physicians in rehabilitation involved in scoliosis management at ISICO.
All participants must have adequate cognitive and language abilities to take part in discussions and complete questionnaires.
Sample Size:
Part I: Involves the 8 ISICO physicians performing clinical visits.
The main outcome measure is the variation in treatment decisions before and after exposure to the CDSS.
With α = 0.05, power = 80%, and expected effect size (Cohen's d = 0.3), the minimum required sample size is 175 clinical cases.
Parts II-III (Focus Groups):
6-12 patients
6-12 parents
6-10 physicians These group sizes align with qualitative research standards to ensure thematic saturation.
Safety Evaluation:
Adverse events will be monitored, recorded, and assessed by the Data Safety Monitoring Committee (DSMC).
Statistical and Analytical Plan:
Quantitative analysis will evaluate:
The frequency, nature, and motivations behind changes in treatment plans after using CDSS recommendations.
Correlations between CDSS suggestions and clinicians' treatment decisions.
Qualitative analysis will interpret data from focus group discussions to identify patterns, trends, and associations between CDSS recommendations, clinical choices, and possible alternative decisions had the CDSS been applied.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: