Affordable, Tailored Physical Therapy for Financially Vulnerable People With Trauma-related Injuries (AFTER-TRAUMA) (AFTER-TRAUMA)
Affordable, Tailored Physical Therapy for Financially Vulnerable People With Trauma-related Injuries (AFTER-TRAUMA): a Prospective Cohort Study
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Indy Smits, MSc
- Número de teléfono: +243614892
- Correo electrónico: indy.smits@radboudumc.nl
Copia de seguridad de contactos de estudio
- Nombre: Niek Koenders, PhD
- Número de teléfono: +243614892
Ubicaciones de estudio
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Gelderland
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Nijmegen, Gelderland, Países Bajos, 6525
- Reclutamiento
- Radboud University Medical Center
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Contacto:
- Indy Smits, MSc
- Número de teléfono: +243614892
- Correo electrónico: indy.smits@radboudumc.nl
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Investigador principal:
- Niek Koenders, PhD
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Adults ≥ 18 years
- Trauma-related injury and an Injury Severity Score (ISS) ≥ 9 points
- Admitted ≥ 24 hours to the Radboudumc
Exclusion Criteria:
- Delirium, dementia, or depression
- Unable to participate in the informed consent procedure
- Life expectancy < 3 months
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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Multitrauma
Trauma patients with an ISS >8
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PROMIS Questionnaires
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Health-related quality of life measured by PROMIS® Global-02
Periodo de tiempo: 1 week before injury (retrospectively assessed at enrolment), 1 week, 6 weeks, 12 weeks, 6 months, and 12 months after injury.
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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.
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1 week before injury (retrospectively assessed at enrolment), 1 week, 6 weeks, 12 weeks, 6 months, and 12 months after injury.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Perceived health measured by PROMIS® Global01
Periodo de tiempo: Baseline (1 week prior to injury, assessed retrospectively at enrolment), 1 week, 6 weeks, 12 weeks, 6 months, and 12 months after injury.
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Perceived health is assessed using PROMIS® Global01.
Participants rate their overall health on a 5-point scale ranging from 1 (poor) to 5 (excellent).
Higher scores indicate better perceived health.
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Baseline (1 week prior to injury, assessed retrospectively at enrolment), 1 week, 6 weeks, 12 weeks, 6 months, and 12 months after injury.
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Social functioning measured by PROMIS® Ability to Participate in Social Roles and Activities Short Form 4a
Periodo de tiempo: Baseline (1 week prior to injury, assessed retrospectively at enrolment), 1 week, 6 weeks, 12 weeks, 6 months, and 12 months after injury.
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Social functioning is assessed using the PROMIS® Ability to Participate in Social Roles and Activities Short Form 4a.
The questionnaire contains 4 items scored on 5-point response scales.
Total scores range from 4 to 20.
Higher scores indicate better social functioning and participation.
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Baseline (1 week prior to injury, assessed retrospectively at enrolment), 1 week, 6 weeks, 12 weeks, 6 months, and 12 months after injury.
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Physical functioning measured by PROMIS® Physical Function Short Form 8b
Periodo de tiempo: Baseline (1 week prior to injury, assessed retrospectively at enrolment), 1 week, 6 weeks, 12 weeks, 6 months, and 12 months after injury.
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Physical functioning is assessed using the PROMIS® Physical Function Short Form 8b.
The questionnaire contains 8 items scored on 5-point response scales.
Total scores range from 8 to 40.
Higher scores indicate better physical functioning.
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Baseline (1 week prior to injury, assessed retrospectively at enrolment), 1 week, 6 weeks, 12 weeks, 6 months, and 12 months after injury.
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Anxiety measured by PROMIS® Anxiety Short Form 4a
Periodo de tiempo: Baseline (1 week prior to injury, assessed retrospectively at enrolment), 1 week, 6 weeks, 12 weeks, 6 months, and 12 months after injury.
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Anxiety is assessed using the PROMIS® Anxiety Short Form 4a.
The questionnaire contains 4 items scored from 1 to 5. Total scores range from 4 to 20.
Higher scores indicate greater anxiety symptoms.
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Baseline (1 week prior to injury, assessed retrospectively at enrolment), 1 week, 6 weeks, 12 weeks, 6 months, and 12 months after injury.
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Depressive symptoms measured by PROMIS® Depression Short Form 4a
Periodo de tiempo: Baseline (1 week prior to injury, assessed retrospectively at enrolment), 1 week, 6 weeks, 12 weeks, 6 months, and 12 months after injury.
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Depressive symptoms are assessed using the PROMIS® Depression Short Form 4a.
The questionnaire contains 4 items scored from 1 to 5. Total scores range from 4 to 20.
Higher scores indicate greater depressive symptoms
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Baseline (1 week prior to injury, assessed retrospectively at enrolment), 1 week, 6 weeks, 12 weeks, 6 months, and 12 months after injury.
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Fatigue measured by PROMIS® Fatigue Short Form 4a
Periodo de tiempo: Baseline (1 week prior to injury, assessed retrospectively at enrolment), 1 week, 6 weeks, 12 weeks, 6 months, and 12 months after injury.
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Fatigue is assessed using the PROMIS® Fatigue Short Form 4a.
The questionnaire contains 4 items scored from 1 to 5. Total scores range from 4 to 20.
Higher scores indicate greater fatigue.
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Baseline (1 week prior to injury, assessed retrospectively at enrolment), 1 week, 6 weeks, 12 weeks, 6 months, and 12 months after injury.
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Pain intensity measured by PROMIS® Numeric Rating Scale v1.0 Pain Intensity 1a
Periodo de tiempo: Baseline (1 week prior to injury, assessed retrospectively at enrolment), 1 week, 6 weeks, 12 weeks, 6 months, and 12 months after injury.
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Pain intensity is assessed using the PROMIS® Numeric Rating Scale v1.0 Pain Intensity 1a.
Scores range from 0 (no pain) to 10 (worst imaginable pain).
Higher scores indicate greater pain intensity.
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Baseline (1 week prior to injury, assessed retrospectively at enrolment), 1 week, 6 weeks, 12 weeks, 6 months, and 12 months after injury.
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Silla de estudio: Niek Koenders, PhD, Radboud University Medical Center
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- NL2026-18844
- WCF CALL 2024-2025 (Otro número de subvención/financiamiento: Wetenschappelijk College Fysiotherapie (KNGF))
Plan de datos de participantes individuales (IPD)
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Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
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