PainTrain-AI Pilot: Feasibility, Usability (SUS) and Concept-Shift in Primary Care and a Specialized Setting

NCT07497997 | Not Yet Recruiting

• 1 other identifier: PT-AI-PILOT-2026
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot will assess feasibility and usability (SUS) and explore concept shift (reduction of neurophysiology misconceptions) after exposure to a behavioral educational intervention (PainTrain AI), a digital clinical simulation "fenced" by evidence (RAG) for safe, non diagnostic training. The study will be conducted in Primary Care and in a specialized comparative setting, without patient data collection. Primary endpoint: SUS score. Secondary endpoints: concept shift, adherence to micromodules, and interaction latency as friction metric. The platform does not generate clinical advice; it retrieves validated teaching content.

Conditions

Chronic Musculoskeletal Pain

Keywords

chronic musculoskeletal pain; clinical simulation; digital training; educational intervention; usability (SUS); concept shift; primary care professionals

Outcome Measures

Primary Outcomes (1)

• Usability (SUS, 0-100)

  Usability will be assessed using the System Usability Scale (SUS), a validated 10-item questionnaire that yields a score from 0 to 100. Higher scores indicate better usability. Participants will complete the SUS after interacting with the PainTrain-AI educational simulation for the predefined training period. The primary feasibility criterion is achieving a mean SUS score ≥75, indicating good usability.

  4-8 weeks after onboarding

Secondary Outcomes (3)

• Concept Shift

  4-8 weeks.

• Adherence

  4-8 weeks

• Latency/friction

  4-8 weeks

Study Arms (1)

PainTrain-AI Behavioral Training

EXPERIMENTAL

Participants in this arm will receive the behavioral educational intervention PainTrain-AI, a digital clinical simulation that uses a retrieval-augmented generation (RAG) safety architecture to deliver evidence-based teaching content. The platform provides simulated dialogues with virtual standardized patients to train biopsychosocial reasoning about chronic pain. All participants receive the same intervention; there is no control group.

Behavioral: PainTrain-AI Behavioral Training

Interventions

PainTrain-AI Behavioral Training BEHAVIORAL

PainTrain-AI is a behavioral educational intervention delivered through a digital clinical simulation platform. The system uses a retrieval-augmented generation (RAG) safety architecture to ensure that all responses are generated only from validated pedagogical content. Participants engage in simulated dialogues with virtual standardized patients to practice biopsychosocial reasoning about chronic pain. The intervention is non-diagnostic, does not provide clinical advice, and does not involve patient data. All participants receive the same intervention.

PainTrain-AI Behavioral Training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Health professionals in Primary Care (medicine, physiotherapy, nursing, psychology, nutrition) and specialized setting; willingness to use the platform; institutional approval.

You may not qualify if:

• lack of institutional access; unavailability during pilot window

Sponsors & Collaborators

• Francesc Valenzuela Pascual: lead

Study Sites (1)

Universitat de Lleida

Lleida, Lleida, 25198, Spain

Location

Study Officials

• Fran Valenzuela-Pascual, Dr.

  Institut de Recerca Biomèdica de Lleida (IRBLleida) / Universitat de Lleida (UdL)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fran Valenzuela-Pascual, Dr

CONTACT

+34 973 702 459; fran.valenzuela@udl.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: This is an open-label feasibility study. No masking is applied. All participants receive the same behavioral educational intervention, and the study does not involve patient data or clinical outcomes that require blinded assessment.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 23, 2026
• First Posted: March 27, 2026
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: April 2, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)