Adolescent Idiopathic Scoliosis (AIS)PREPARENCT07379593
Validation of the Clinical Decision Support Systems (CDSS) Developed in the EU Horizon PREPARE Project in the Rehabilitative Treatment of Idiopathic Scoliosis
A study testing CDSS simulation, Focus group - clinicians and Focus group - patients in people with Adolescent Idiopathic Scoliosis (AIS), run by Istituto Scientifico Italiano Colonna Vertebrale at 1 site in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 10 years and olderHealthy volunteers can take part
- Conditions the study is for
- Adolescent Idiopathic Scoliosis (AIS)
- What is being tested?
- CDSS simulation, Focus group - clinicians and Focus group - patients
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 178 participants
- Where
- 1 siteItaly
- Study dates
- 7 Nov 2025to 30 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 10 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Initial visits or follow-up appointments of patients with IS attending the Milan site of ISICO - Italian Scientific Spine Institute for rehabilitative treatment;
- Age between 10 and 18 years;
- Informed consent to participate in the study
Who cannot join
- Visits not related to the treatment of IS (other spinal conditions);
- Patients undergoing treatment at other clinics or hospitals.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Adolescent Idiopathic Scoliosis (AIS)
- Being tested
- CDSS simulation, Focus group - clinicians, Focus group - patients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CDSS simulationOther
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
Focus group - cliniciansOther
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.
Focus group - patientsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Clinical Impact of the CDSS | Experimental | The study aims to investigate the potential clinical impact of the CDSS on the prescription of rehabilitative treatment for idiopathic scoliosis (IS). Specifically, it seeks to answer the following question:
Would clinical decisions regarding the treatment of IS have changed if clinicians had access to the information provided by the CDSS to discuss with the patient? Receives: Other: CDSS simulation |
| Impact of the CDSS on clinicians | Other | Focus grous designed to explore the perspectives, experiences, and perceptions of physicians regarding the use of the CDSS in daily clinical practice. Receives: Other: Focus group - clinicians |
| Impact of the CDSS on Patients | Other | The main objective is to explore patients' perspectives on the implementation of CDSS. The aim is to understand patients' experiences with CDSS, including their interactions with the system and their perceptions of its usefulness and relevance in the care pathway. The study also seeks to identify factors that influence patients' acceptance and usability of CDSS, such as interface design, clarity of information, and alignment with patients' preferences. Finally, we aim to evaluate the impact of CDSS on patient engagement and their satisfaction with the care experience, including the extent to which CDSS facilitate informed decision-making and communication between patients and healthcare providers. Receives: Other: Focus group - patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in clinical decision
To assess the impact of the CDSS on clinical decisions, a mixed-methods approach, combining quantitative and qualitative analyses, will be adopted. The primary quantitative outcome measure will be the proportion of clinical cases in which the therapeutic decision changes after exposure to the CDSS, defined as a binary outcome (change vs. no change in treatment plan). Therapeutic decisions made before and after CDSS consultation will be compared within the same case.
Differences in paired pre- and post-CDSS therapeutic decisions will be evaluated using McNemar's test, which is appropriate for assessing changes in paired binary outcomes. Qualitative analyses will explore clinicians' rationale for decision changes and their perceptions of CDSS influence.
Measured: Throughout study completion, an avarage of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2026
- Study start7 Nov 2025
- Primary completion1 Mar 2027 (estimated)
- Study completion30 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent Idiopathic Scoliosis (AIS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 178 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Scientifico Italiano Colonna Vertebrale
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07379593
- Sponsor's protocol ID
- PREPARE-pros
- Acronym
- PREPARE
- Status last verified
- Oct 2026
- First submitted
- 15 Jan 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Aninymized data will be uploaded on a public repository
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the Clinical Decision Support Systems (CDSS) Developed in the EU Horizon PREPARE Project in the Rehabilitative Treatment of Idiopathic Scoliosis
- ClinicalTrials.gov ID
- NCT07379593
- Acronym / sponsor ID
- PREPARE / PREPARE-pros
- Conditions
- Adolescent Idiopathic Scoliosis (AIS)
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 178 participants (estimated)
- Lead sponsor
- Istituto Scientifico Italiano Colonna VertebraleUniversity, hospital or other
- Study start
- 7 Nov 2025 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 30 May 2027 (estimated)
- First posted
- 30 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Clinical Impact of the CDSS | Experimental | Other: CDSS simulationThe study aims to investigate the potential clinical impact of the CDSS on the prescription of rehabilitative treatment for idiopathic scoliosis (IS). Specifically, it seeks to answer the following question: Would clinical decisions regarding the treatment of IS have changed if clinicians had access to the information provided by the CDSS to discuss with the patient? |
| Impact of the CDSS on clinicians | Other | Other: Focus group - cliniciansFocus grous designed to explore the perspectives, experiences, and perceptions of physicians regarding the use of the CDSS in daily clinical practice. |
| Impact of the CDSS on Patients | Other | Other: Focus group - patientsThe main objective is to explore patients' perspectives on the implementation of CDSS. The aim is to understand patients' experiences with CDSS, including their interactions with the system and their perceptions of its usefulness and relevance in the care pathway. The study also seeks to identify factors that influence patients' acceptance and usability of CDSS, such as interface design, clarity of information, and alignment with patients' preferences. Finally, we aim to evaluate the impact of CDSS on patient engagement and their satisfaction with the care experience, including the extent to which CDSS facilitate informed decision-making and communication between patients and healthcare providers. |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Initial visits or follow-up appointments of patients with IS attending the Milan site of ISICO - Italian Scientific Spine Institute for rehabilitative treatment;
- Age between 10 and 18 years;
- Informed consent to participate in the study
Key exclusion criteria (2 listed)
- Visits not related to the treatment of IS (other spinal conditions);
- Patients undergoing treatment at other clinics or hospitals.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CDSS simulationThe 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 | Clinical Impact of the CDSS |
| Focus group - cliniciansFocus 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 | Impact of the CDSS on clinicians |
| Focus group - patientsTwo 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. | Other | Impact of the CDSS on Patients |
Primary outcome
Changes in clinical decision
Time frame: Throughout study completion, an avarage of 6 months
To assess the impact of the CDSS on clinical decisions, a mixed-methods approach, combining quantitative and qualitative analyses, will be adopted. The primary quantitative outcome measure will be the proportion of clinical cases in which the therapeutic decision changes after exposure to the CDSS, defined as a binary outcome (change vs. no change in treatment plan). Therapeutic decisions made before and after CDSS consultation will be compared within the same case. Differences in paired pre- and post-CDSS therapeutic decisions will be evaluated using McNemar's test, which is appropriate for assessing changes in paired binary outcomes. Qualitative analyses will explore clinicians' rationale for decision changes and their perceptions of CDSS influence.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Individual participant dataSharing planned: Yes. Aninymized data will be uploaded on a public repository
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CDSS simulation, Focus group - clinicians and Focus group - patients in people with Adolescent Idiopathic Scoliosis (AIS), run by Istituto Scientifico Italiano Colonna Vertebrale at 1 site in Italy.
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 3 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: under way, not looking for participants, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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?
This study is still under way. Results are not available in the source record yet.
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?
Changes in clinical decision (time frame: Throughout study completion, an avarage of 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Oct 2026.