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Recruiting NCT07795216

Affordable, Tailored Physical Therapy for Financially Vulnerable People With Trauma-related Injuries (AFTER-TRAUMA)

Conditions: Quality of Life, PROMs

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 153
Sponsor: Radboud University Medical Center

Location: Radboud University Medical Center Nijmegen Gelderland

Summary

SUMMARY Rationale: In the Netherlands, trauma-related injuries affect more than 700,000 people annually, and many require rehabilitation. Regardless of trauma-related injuries, over 500,000 individuals live in financial vulnerability, often characterized as having low socioeconomic status (SES). Patients with low SES have an increased risk of sustaining trauma and generally experience poorer recovery outcomes. Access to physical therapy care is limited for this population, despite the substantial impact of trauma on quality of life and daily functioning. Little is known about their long-term rehabilitation outcomes. This study aims to improve understanding of recovery patterns in patients with trauma-related injuries and explores whether outcomes differ between SES-groups. Objective: The primary objective is to assess quality of life 1 week prior to the injury, and at 1 week, 6 weeks, 12 weeks, 6 months, and 1 year after trauma-related injury. Secondary objectives include evaluating social, physical and mental functioning, fatigue, pain, and return-to-work. Outcomes will be compared across socioeconomic groups to explore how financial vulnerability is associated with recovery. Study design: Prospective, longitudinal cohort study. Study population: In total 185 patients (≥18 years) with trauma-related injuries (ISS ≥9) admitted to the Radboud University Medical Center will be included between April 2026 and October 2027. Main study parameters/endpoints: The primary outcome is quality of life, measured using validated PROMIS® Global02 at all follow-up timepoints. Secondary outcomes include perceived health, social, physical, and mental functioning, fatigue, and pain, assessed using validated PROMIS® questionnaires at the same follow up moments. SES indicators (postal code, education level, type of employment), health insurance coverage, and work status will also be collected. Nature and extent of the burden and risks associated with participation, benefit, and group relatedness: Participation involves minimal burden and no medical risks. Patients are asked to complete digital of paper questionnaires at predefined intervals with a burden of approximately 10 minutes per follow-up interval. No additional procedures or treatments are required. The participant will receive a compensation of €5 for each completed questionnaire. The study is expected to generate valuable insights that can improve quality, accessibility, and tailoring of physical therapy care for future trauma patients, particularly those in a financially vulnerable situation.

Eligibility Criteria

Inclusion Criteria: 1. Adults ≥ 18 years 2. Trauma-related injury and an Injury Severity Score (ISS) ≥ 9 points 3. Admitted ≥ 24 hours to the Radboudumc Exclusion Criteria: 1. Delirium, dementia, or depression 2. Unable to participate in the informed consent procedure 3. Life expectancy \< 3 months

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07795216). StuddyBuddy aggregates publicly available trial information.