- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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
Aperçu de l'étude
Statut
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Indy Smits, MSc
- Numéro de téléphone: +24 361 1111
- E-mail: indy.smits@radboudumc.nl
Sauvegarde des contacts de l'étude
- Nom: Niek Koenders, PhD
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
La 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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
|---|
|
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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Needs Regarding Physical Therapy Treatment
Délai: 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)
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chaise d'étude: Niek Koenders, PhD, Radboud University Medical Center
Publications et liens utiles
Publications générales
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- NL2026-19368
- WCF CALL 2024-2025 (Autre subvention/numéro de financement: Wetenschappelijk College Fysiotherapie (KNGF))
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .