PROMs, Quality of Life
Conditions
Keywords
Multitrauma, PROMIS
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.
Interventions
OTHERQuestionnaires
PROMIS Questionnaires
Sponsors
Radboud University Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Health-related quality of life measured by PROMIS® Global-02 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. |
| 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. | 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. |
| 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. | 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. |
| 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. | 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. |
| 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. | 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 |
| Fatigue measured by PROMIS® Fatigue 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. | 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. |
| Pain intensity measured by PROMIS® Numeric Rating Scale v1.0 Pain Intensity 1a | 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. |
Countries
Netherlands
Contacts
CONTACTIndy Smits, MSc
CONTACTNiek Koenders, PhD
STUDY_CHAIRNiek Koenders, PhD
Radboud University Medical Center
Outcome results
None listed