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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Estimado)
Contactos e Locais
Contato de estudo
- Nome: Indy Smits, MSc
- Número de telefone: +243614892
- E-mail: indy.smits@radboudumc.nl
Estude backup de contato
- Nome: Niek Koenders, PhD
- Número de telefone: +243614892
Locais de estudo
-
-
Gelderland
-
Nijmegen, Gelderland, Holanda, 6525
- Recrutamento
- Radboud University Medical Center
-
Contato:
- Indy Smits, MSc
- Número de telefone: +243614892
- E-mail: indy.smits@radboudumc.nl
-
Investigador principal:
- Niek Koenders, PhD
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Método de amostragem
População do estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
|
Multitrauma
Trauma patients with an ISS >8
|
PROMIS Questionnaires
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Health-related quality of life measured by PROMIS® Global-02
Prazo: 1 week before injury (retrospectively assessed at enrolment), 1 week, 6 weeks, 12 weeks, 6 months, and 12 months after injury.
|
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.
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Perceived health measured by PROMIS® Global01
Prazo: Baseline (1 week prior to injury, assessed retrospectively at enrolment), 1 week, 6 weeks, 12 weeks, 6 months, and 12 months after injury.
|
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.
|
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
Prazo: 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 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.
|
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
Prazo: 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 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.
|
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
Prazo: Baseline (1 week prior to injury, assessed retrospectively at enrolment), 1 week, 6 weeks, 12 weeks, 6 months, and 12 months after injury.
|
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.
|
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
Prazo: 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 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
|
Baseline (1 week prior to injury, assessed retrospectively at enrolment), 1 week, 6 weeks, 12 weeks, 6 months, and 12 months after injury.
|
|
Fatigue measured by PROMIS® Fatigue Short Form 4a
Prazo: Baseline (1 week prior to injury, assessed retrospectively at enrolment), 1 week, 6 weeks, 12 weeks, 6 months, and 12 months after injury.
|
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.
|
Baseline (1 week prior to injury, assessed retrospectively at enrolment), 1 week, 6 weeks, 12 weeks, 6 months, and 12 months after injury.
|
|
Pain intensity measured by PROMIS® Numeric Rating Scale v1.0 Pain Intensity 1a
Prazo: Baseline (1 week prior to injury, assessed retrospectively at enrolment), 1 week, 6 weeks, 12 weeks, 6 months, and 12 months after injury.
|
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.
|
Baseline (1 week prior to injury, assessed retrospectively at enrolment), 1 week, 6 weeks, 12 weeks, 6 months, and 12 months after injury.
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Cadeira de estudo: Niek Koenders, PhD, Radboud University Medical Center
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- NL2026-18844
- WCF CALL 2024-2025 (Número de outro subsídio/financiamento: Wetenschappelijk College Fysiotherapie (KNGF))
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .