- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07819877
Affordable, Tailored Therapy for Financially Vulnerable People With Trauma-related Injuries (AFTER-TRAUMA)
What Are the Needs of Financially Vulnerable People With Trauma-related Injuries Related to Physical Therapy Treatment (AFTER-TRAUMA): a Qualitative, Grounded Theory Study
Study Overview
Status
Detailed Description
Trauma-related injuries can have substantial long-term consequences for functioning, participation, and quality of life. Financial vulnerability is associated with both an increased risk of traumatic injury and poorer recovery outcomes. Financially vulnerable patients may experience barriers in accessing physical therapy, obtaining assistive devices, arranging transportation, or prioritizing rehabilitation alongside competing financial demands.
Despite the recognized importance of physical therapy in trauma rehabilitation, little is known about the specific needs of financially vulnerable individuals. This study aims to develop a conceptual understanding of these needs using constructivist grounded theory methodology. Data will be collected through semi-structured interviews, participant observations, and supplementary qualitative sources such as documents, photographs, videos, and social media content provided voluntarily by participants.
Participants will be adults with trauma-related injuries and self-reported financial concerns living in the Netherlands. Recruitment will follow purposive, snowball, and theoretical sampling principles. Data collection and analysis will proceed iteratively until theoretical saturation is achieved. Findings are expected to contribute to more accessible and tailored physical therapy services for financially vulnerable trauma survivors.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Indy Smits, MSc
- Phone Number: +24 361 1111
- Email: indy.smits@radboudumc.nl
Study Contact Backup
- Name: Niek Koenders, PhD
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adults aged 18 years or older
- Trauma-related injury with Injury Severity Score (ISS) ≥16
- Injury occurred between 3 months and 2 years prior to participation
- Self-reported financial concerns
- Living in the Netherlands
- Able and willing to provide informed consent
Exclusion Criteria:
- Unable to understand or speak Dutch
- Cognitive impairment preventing participation in interviews
- Severe mental health conditions preventing meaningful participation
- Life expectancy less than 3 months
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
Financially vulnerable people with trauma-related injuries
Adults aged 18 years and older with trauma-related injuries (ISS ≥16) and self-reported financial concerns living in the Netherlands.
Participants may have received physical therapy or may not have received physical therapy after injury.
Data collection includes interviews and observations.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Needs Regarding Physical Therapy Treatment
Time Frame: Single study interview and observation period (October 2026 to June 2027)
|
Conceptual understanding of the needs of financially vulnerable people with trauma-related injuries regarding physical therapy treatment, identified through qualitative interviews, participant observations, documents, footage, and social media content analyzed using constructivist grounded theory methods.
|
Single study interview and observation period (October 2026 to June 2027)
|
Collaborators and Investigators
Investigators
- Study Chair: Niek Koenders, PhD, Radboud University Medical Center
Publications and helpful links
General Publications
- O'Brien BC, Harris IB, Beckman TJ, Reed DA, Cook DA. Standards for reporting qualitative research: a synthesis of recommendations. Acad Med. 2014 Sep;89(9):1245-51. doi: 10.1097/ACM.0000000000000388.
- Hennink M, Kaiser BN. Sample sizes for saturation in qualitative research: A systematic review of empirical tests. Soc Sci Med. 2022 Jan;292:114523. doi: 10.1016/j.socscimed.2021.114523. Epub 2021 Nov 2.
- Charmaz K. Teaching Theory Construction With Initial Grounded Theory Tools: A Reflection on Lessons and Learning. Qual Health Res. 2015 Dec;25(12):1610-22. doi: 10.1177/1049732315613982.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NL2026-19368
- WCF CALL 2024-2025 (Other Grant/Funding Number: Wetenschappelijk College Fysiotherapie (KNGF))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.