NCT07819877

Brief 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. 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for all trials

Timeline
8mo left

Started Oct 2026

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress1%
Oct 2026Jun 2027

First Submitted

Initial submission to the registry

September 9, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 15, 2026

Completed
16 days until next milestone

Study Start

First participant enrolled

October 1, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

September 15, 2026

Status Verified

August 1, 2026

Enrollment Period

8 months

First QC Date

September 9, 2026

Last Update Submit

September 9, 2026

Conditions

Keywords

Needsfinancial vulnerabilitySocioeconomic disadvantagephysical therapyphysiotherapygrounded theoryqualitative researchRehabilitation

Outcome Measures

Primary Outcomes (1)

  • 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.

    Single study interview and observation period (October 2026 to June 2027)

Study Arms (1)

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.

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 24979285BACKGROUND
  • 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.

    PMID: 34785096BACKGROUND
  • 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.

    PMID: 26646825BACKGROUND

MeSH Terms

Conditions

Wounds and InjuriesMultiple Trauma

Study Officials

  • Niek Koenders, PhD

    Radboud University Medical Center

    STUDY CHAIR

Central Study Contacts

Niek Koenders, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2026

First Posted

September 15, 2026

Study Start

October 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

September 15, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Individual qualitative data contain potentially identifiable and sensitive participant information. De-identified datasets will not be made publicly available to protect participant confidentiality.