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

2026年8月26日 更新者：Radboud University Medical Center

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.

調査の概要

状態

募集

条件

介入・治療

研究の種類

観察的

入学 (推定)

153

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究連絡先のバックアップ

  • 名前：Niek Koenders, PhD
  • 電話番号：+243614892

研究場所

  • オランダ
    • Gelderland
      • Nijmegen、Gelderland、オランダ、6525
        • 募集
        • Radboud University Medical Center
        • コンタクト：
        • 主任研究者：
          • Niek Koenders, PhD

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

サンプリング方法

非確率サンプル

調査対象母集団

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.

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

コホートと介入

グループ/コホート
介入・治療
Multitrauma
Trauma patients with an ISS >8
他の：Questionnaires
PROMIS Questionnaires

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Health-related quality of life measured by PROMIS® Global-02
時間枠：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.

二次結果の測定

結果測定
メジャーの説明
時間枠
Perceived health measured by PROMIS® Global01
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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.

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Radboud University Medical Center

捜査官

  • スタディチェア：Niek Koenders, PhD、Radboud University Medical Center

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2026年4月2日

一次修了 (推定)

2027年9月30日

研究の完了 (推定)

2027年9月30日

試験登録日

最初に提出

2026年8月17日

QC基準を満たした最初の提出物

2026年8月26日

最初の投稿 (実際)

2026年8月31日

学習記録の更新

投稿された最後の更新 (実際)

2026年8月31日

QC基準を満たした最後の更新が送信されました

2026年8月26日

最終確認日

2026年8月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • NL2026-18844
  • WCF CALL 2024-2025 (その他の助成金/資金番号：Wetenschappelijk College Fysiotherapie (KNGF))

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

IPD プランの説明

Not allowed

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米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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