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

NCT07795216 | Recruiting

• 2 other identifiers: NL2026-18844WCF CALL 2024-2025
• Study Type: observational
• Target: 153
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Quality of Life; PROMs

Keywords

Multitrauma; PROMIS

Outcome Measures

Primary Outcomes (1)

• Health-related quality of life measured by PROMIS® Global-02

  Health-related quality of life is assessed using PROMIS® Global02. Participants rate their overall quality of life on a 5-point scale ranging from 1 (poor) to 5 (excellent). Higher scores indicate better health-related quality of life.

  1 week before injury (retrospectively assessed at enrolment), 1 week, 6 weeks, 12 weeks, 6 months, and 12 months after injury.

Secondary Outcomes (7)

• Perceived health measured by PROMIS® Global01

  Baseline (1 week prior to injury, assessed retrospectively at enrolment), 1 week, 6 weeks, 12 weeks, 6 months, and 12 months after injury.

• Social functioning measured by PROMIS® Ability to Participate in Social Roles and Activities Short Form 4a

  Baseline (1 week prior to injury, assessed retrospectively at enrolment), 1 week, 6 weeks, 12 weeks, 6 months, and 12 months after injury.

• Physical functioning measured by PROMIS® Physical Function Short Form 8b

  Baseline (1 week prior to injury, assessed retrospectively at enrolment), 1 week, 6 weeks, 12 weeks, 6 months, and 12 months after injury.

• Anxiety measured by PROMIS® Anxiety Short Form 4a

  Baseline (1 week prior to injury, assessed retrospectively at enrolment), 1 week, 6 weeks, 12 weeks, 6 months, and 12 months after injury.

• Depressive symptoms measured by PROMIS® Depression Short Form 4a

  Baseline (1 week prior to injury, assessed retrospectively at enrolment), 1 week, 6 weeks, 12 weeks, 6 months, and 12 months after injury.

Study Arms (1)

Multitrauma

Trauma patients with an ISS \>8

Other: Questionnaires

Interventions

Questionnaires OTHER

PROMIS Questionnaires

Multitrauma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of patients 18 years or older with trauma-related injuries admitted to the Radboud University Medical Center (Radboudumc). In the Netherlands, 722,050 people experience trauma-related injuries each year \[1\]. In 2024, a total of 75,232 patients with injuries were registered in the National Trauma Registry (LRT) \[13\]. At the Radboud University Medical Center, we treated 508 severely injured patients in 2024 (Injury Severity Score (ISS) ≥16). Data for patients with an ISS between 9 and 15, treated at the Radboud University Medical Center, is not available.

You may qualify if:

• Adults ≥ 18 years
• Trauma-related injury and an Injury Severity Score (ISS) ≥ 9 points
• Admitted ≥ 24 hours to the Radboudumc

You may not qualify if:

• Delirium, dementia, or depression
• Unable to participate in the informed consent procedure
• Life expectancy \< 3 months

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

Radboud University Medical Center

Nijmegen, Gelderland, 6525, Netherlands

RECRUITING

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Niek Koenders, PhD

  Radboud University Medical Center

  STUDY CHAIR

Central Study Contacts

Indy Smits, MSc

CONTACT

+243614892; indy.smits@radboudumc.nl

Niek Koenders, PhD

CONTACT

+243614892

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2026
• First Posted: August 31, 2026
• Study Start: April 2, 2026
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: August 31, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)