- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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
Descripción general del estudio
Estado
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Indy Smits, MSc
- Número de teléfono: +24 361 1111
- Correo electrónico: indy.smits@radboudumc.nl
Copia de seguridad de contactos de estudio
- Nombre: Niek Koenders, PhD
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Needs Regarding Physical Therapy Treatment
Periodo de tiempo: Single study interview and observation period (October 2026 to June 2027)
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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.
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Single study interview and observation period (October 2026 to June 2027)
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Silla de estudio: Niek Koenders, PhD, Radboud University Medical Center
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- NL2026-19368
- WCF CALL 2024-2025 (Otro número de subvención/financiamiento: Wetenschappelijk College Fysiotherapie (KNGF))
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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