Effectiveness and cost-effectiveness of the Transmural Trauma Care Model (TTCM), a non randomized controlled multicenter trial
Recruiting
- Conditions
- broken bonefracture1001732210005944
- Registration Number
- NL-OMON52603
- Lead Sponsor
- Vrije Universiteit Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 644
Inclusion Criteria
• Age >= 16 years old
• 1 or more fracture(s) as a result of a trauma
• Able to fill in online questionnaires in Dutch
• Able to give informed consent
• At least one outpatient consultation of the trauma surgeon
Exclusion Criteria
• Patients with traumatic brain injury
• Pathological fractures
• Severe psychopathology (e.g. schizophrenia, high risk suicidality)
• Cognitive limitations
• Living in an institution (e.g. nursing home)
• Does not speak/ understand Dutch
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Co-primary outcomes<br /><br>The co-primary outcomes are generic quality of life (EQ 5D-5L) and<br /><br>disease-specific quality of life (standardized Patient Reported Outcomes<br /><br>[PROMS]). Choice of measurement of dis-ease-specific quality of life depends on<br /><br>trauma location:<br /><br>- upper extremity: QuickDASH DLV<br /><br>- lower extremity: Lower Extremity Functional Scale (LEFS)<br /><br>- multiple fractures and/or more locations: Groningen activiteiten restrictie<br /><br>schaal (GARS)<br /><br>- back: The Roland Morris Disability Questionnaire (RMDQ)<br /><br>Co-primary outcomes are measured at baseline, 6 weeks, 3 months, 6 months and 9<br /><br>months.</p><br>
- Secondary Outcome Measures
Name Time Method