Trauma (Including Fractures)AFTER-TRAUMANCT07819877
Affordable, Tailored Therapy for Financially Vulnerable People With Trauma-related Injuries
An observational study of Trauma (Including Fractures) and Multiple Trauma/Injuries, run by Radboud University Medical Center.
Trial summary
Financially vulnerable people experience higher rates of trauma-related injuries and often face barriers to accessing physical therapy services. Current rehabilitation services may not sufficiently align with the circumstances and needs of this population. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Trauma (Including Fractures), Multiple Trauma/Injuries, Rehabilitation
- How many people
- 17 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 1 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of adults aged 18 years or older with severe trauma-related injuries (ISS ≥16) who live in financial vulnerability in the Netherlands. Eligible participants experienced their injury between 3 months and 2 years before study participation and report financial concerns. Maximum variation sampling will be used to ensure diversity in age, sex, educational level, geographic region, rehabilitation pathway, and experiences with physical therapy. Recruitment will follow purposive, snowball, and theoretical sampling principles consistent with constructivist grounded theory methodology.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Niek Koenders, PhD contact
About this study
Official title: What Are the Needs of Financially Vulnerable People With Trauma-related Injuries Related to Physical Therapy Treatment (AFTER-TRAUMA): a Qualitative, Grounded Theory Study
Financially vulnerable people experience higher rates of trauma-related injuries and often face barriers to accessing physical therapy services. Current rehabilitation services may not sufficiently align with the circumstances and needs of this population. This qualitative study aims to develop a conceptual understanding of the needs of financially vulnerable adults with trauma-related injuries regarding physical therapy treatment. Using a constructivist grounded theory approach, data will be collected through semi-structured interviews, participant observations, and supplementary qualitative materials. Findings will support the development of more accessible, tailored, and person-centered physical therapy services.
Read the 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.
- Keywords
- Needs, financial vulnerability, Socioeconomic disadvantage, physical therapy, physiotherapy, grounded theory, qualitative research, Rehabilitation
- Medical subject headings
- Wounds and Injuries, Multiple Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Needs Regarding Physical Therapy Treatment
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.
Measured: Single study interview and observation period (October 2026 to June 2027)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Trauma (Including Fractures)Studies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 17 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Niek Koenders, PhD, Study chair, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07819877
- Sponsor's protocol ID
- NL2026-19368
- Other IDs
- WCF CALL 2024-2025
- Acronym
- AFTER-TRAUMA
- Status last verified
- Aug 2026
- First submitted
- 9 Sep 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual qualitative data contain potentially identifiable and sensitive participant information. De-identified datasets will not be made publicly available to protect participant confidentiality.
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.
PubMed 24979285Hennink 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.
PubMed 34785096Charmaz 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.
PubMed 26646825
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- What Are the Needs of Financially Vulnerable People With Trauma-related Injuries Related to Physical Therapy Treatment (AFTER-TRAUMA): a Qualitative, Grounded Theory Study
- ClinicalTrials.gov ID
- NCT07819877
- Acronym / sponsor ID
- AFTER-TRAUMA / NL2026-19368
- Keywords
- Needs, financial vulnerability, Socioeconomic disadvantage, physical therapy, physiotherapy, grounded theory, qualitative research, Rehabilitation
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 17 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 15 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Financially vulnerable people experience higher rates of trauma-related injuries and often face barriers to accessing physical therapy services. Current rehabilitation services may not sufficiently align with the circumstances and needs of this population. This qualitative study aims to develop a conceptual understanding of the needs of financially vulnerable adults with trauma-related injuries regarding physical therapy treatment. Using a constructivist grounded theory approach, data will be collected through semi-structured interviews, participant observations, and supplementary qualitative materials. Findings will support the development of more accessible, tailored, and person-centered physical therapy services.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adults aged 18 years or older with severe trauma-related injuries (ISS ≥16) who live in financial vulnerability in the Netherlands. Eligible participants experienced their injury between 3 months and 2 years before study participation and report financial concerns. Maximum variation sampling will be used to ensure diversity in age, sex, educational level, geographic region, rehabilitation pathway, and experiences with physical therapy. Recruitment will follow purposive, snowball, and theoretical sampling principles consistent with constructivist grounded theory methodology.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Background: PubMed 24979285O'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.
- Background: PubMed 34785096Hennink 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.
- Background: PubMed 26646825Charmaz 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.
- Individual participant dataSharing planned: No. Individual qualitative data contain potentially identifiable and sensitive participant information. De-identified datasets will not be made publicly available to protect participant confidentiality.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Niek Koenders, PhD contact
Niek Koenders, PhD study chair
Radboud University Medical Center
Questions about this trial
What is this clinical trial studying?
An observational study of Trauma (Including Fractures) and Multiple Trauma/Injuries, run by Radboud University Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Indy Smits, MSc (+24 361 1111, indy.smits@radboudumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Needs Regarding Physical Therapy Treatment (time frame: Single study interview and observation period (October 2026 to June 2027)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07819877, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.