Person-Centred AI Support in Interdisciplinary Rehabilitation for Chronic Pain

NCT07081737 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2025-07-23

No results posted yet for this study

Summary

This cluster randomized controlled trial evaluates whether a person-centred, AI-supported Clinical Decision Support System (CDSS) can improve outcomes and cost-effectiveness in interdisciplinary rehabilitation for people with complex chronic pain. The CDSS is designed to assist clinicians in making personalized treatment decisions within standard interdisciplinary treatment (IDT). It has been developed using machine learning models trained on real-world data from over 100,000 patients in the Swedish Quality Registry for Pain Rehabilitation (SQRP), linked to several national registers, including the National Patient Register, the Prescribed Drug Register, the Social Insurance Agency database (MiDAS), and the Cause of Death Register. This enables individualized predictions of treatment outcomes, work ability, and healthcare utilization.

The trial includes 400 adult patients with chronic pain, enrolled at 20 IDT clinics randomized to either CDSS-supported or standard IDT. The study has three phases: feasibility, effectiveness, and implementation. The primary outcome is a patient-prioritized composite single-index of health-related well-being, based on domains such as pain, sleep, physical and mental health, emotional distress, and work ability. Patients prioritize these domains together with their clinical team, enabling a person-centred assessment. Secondary outcomes include HRQoL (EQ-5D, SF-36), emotional distress (HADS), and work ability (WAI), measured at baseline, post-treatment, 6- and 12-month follow-up.

A parallel mixed-methods process evaluation will examine implementation outcomes such as usability, clinician adherence, and workflow integration, using logs, surveys (e.g., S-NoMAD), and interviews. Normalization Process Theory guides the analysis. Cost-utility will be assessed using QALYs and ICERs from a societal perspective, with long-term projections using simulation models. Results will be reported in peer-reviewed publications.

Conditions

  • Pain, Chronic
  • Chronic Pain, Widespread
  • Pain Management

Interventions

OTHER

Interdisciplinary treatment (IDT) + Clinical Decision Support System (CDSS)

Interdisciplinary treatment (IDT) combined with Clinical Decision Support System (CDSS)

OTHER

Interdisciplinary treatment (IDT)

Interdisciplinary treatment (IDT)

Sponsors & Collaborators

  • Göteborg University

    collaborator OTHER
  • Forte

    collaborator INDUSTRY
  • Dalarna County Council, Sweden

    collaborator OTHER
  • Karolinska Institutet

    collaborator OTHER
  • The Swedish Research Council

    collaborator OTHER_GOV
  • Bjorn Ang

    lead OTHER

Principal Investigators

  • Björn O Äng, Professor · Dalarna University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
67 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-01
Primary Completion
2029-03-31
Completion
2029-03-31

Countries

  • Sweden

Study Locations

More Related Trials

Entities

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 NCT07081737 on ClinicalTrials.gov