- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03967262
Secondary Prevention and Recidivism Reduction in Trauma Patients
The consumption of alcohol and other drugs is one of the main risk factors for traumatism. In addition, patients who have suffered an accident in relation to the consumption of these substances present a high risk of recidivism. In the case of alcohol, its relationship with traumatisms has been known for many years now and is still one of the main risk factors.
Secondary prevention is an important area of action and improvement in the treatment of this type of patient by considering actions, such as a brief motivational intervention, in order to avoid recidivism. The objective of motivational intervention is to make the patient aware of the relationship between the consumption of these substances and the accident, and induce them to carry out a change in habits.
The objective of the present investigation project is to determine the efficacy of secondary prevention in reducing recurrence of traumatisms. In order to this, a multicenter randomised controlled trial has been designed in which the intervention group with patients admitted for sever traumatism with positive screening for alcohol or other drugs, will be submitted to a brief motivational intervention. The main outcome will be trauma recurrence within a three year follow-up.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Barcelona
-
Sabadell, Barcelona, Spanien, 08208
- Corporacion Sanitaria Parc Tauli
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Sever trauma patients defined as the need of assistance in a critical unit.
- Positive screening for alcohol o other drugs (cannabis, cocaine, methamphetamine).
Exclusion Criteria:
- Patients in treatment for abuse of alcohol and other drugs.
- Death during hospitalization.
- Non Catalonia residents.
- Not Spanish or Catalan spoken.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Intervention
|
The objective of motivational intervention is to make the patient aware of the relationship between the consumption of alcohol and other drugs and the accident, and induce them to carry out a change in habits.
|
Ingen indgriben: Styring
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Recurrence of traumatisms
Tidsramme: Follow-up of 3 years
|
Any medical assistance related to a traumatism
|
Follow-up of 3 years
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Alcohol prevalence
Tidsramme: Trough study completion, an average of 2 years
|
Alcohol prevalence among trauma patients
|
Trough study completion, an average of 2 years
|
Other drugs prevalence (cannabis, cocaine, methamphetamine)
Tidsramme: Trough study completion, an average of 2 years
|
Other drugs prevalence among trauma patients
|
Trough study completion, an average of 2 years
|
Time to a recurrence
Tidsramme: Trough study completion, an average of 2 years
|
Time since discharge until the first new trauma or withdrawal from follow-up.
|
Trough study completion, an average of 2 years
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Salvador Navarro-Soto, PhD, Corporacion Sanitaria Parc Tauli
- Studieleder: Salvador Navarro-Soto, PhD, Corporacion Sanitaria Parc Tauli
Datoer for undersøgelser
Studer store datoer
Studiestart (Forventet)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CSPT-CG-PPT2
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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Studerer et amerikansk FDA-reguleret enhedsprodukt
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