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Prospective Abuse and Intimate Partner Violence Surgical Evaluation (PRAISE-2)
Prospective Abuse and Intimate Partner Violence Surgical Evaluation (PRAISE-2) : A Multicentre Pilot Prospective Cohort Study
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
Number of Participants:
250
Primary Research Objectives:
Feasibility
Secondary Research Objective:
The secondary objectives are to determine:
- How a history of IPV affects injury-related complications;
- How a history of IPV affects return to pre-injury function;
- Incident cases of IPV after a musculoskeletal injury, if the injury was not the result of IPV;
- How a history of IPV affects health care and support service use after a musculoskeletal injury;
- How a history of IPV affects health-related quality of life after a musculoskeletal injury;
- How patterns of IPV change over time after a musculoskeletal injury;
- How abused women's stage of change changes over time after a musculoskeletal injury
Diagnosis and Main Inclusion Criteria:
The inclusion criteria are:
- adult females (at least 16 or 18 years of age depending on local ethics requirements);
- patients presenting to participating fracture clinics within 6 weeks of their musculoskeletal injury;
- patients presenting with a fracture or dislocation which is being managed with either surgical or non-surgical treatment.
The exclusion criteria are:
- unwilling to or unable to provide consent;
- unable to complete the study questionnaires in a private location, due to safety and confidentiality;
- unwilling or unable to follow the study protocol or their attending surgeon has concerns about their ability or willingness to follow study protocols;
- does not speak and write in English or the dominant language of the local clinic
Study Outcomes:
The primary outcome is feasibility. Secondary outcomes are injury-related complications, return to function, incidence of IPV, quality of life, abuse type and severity, and stage of change.
Duration of Patient Follow-Up:
Study participants will be followed for 12 months
Studietype
Inschrijving (Werkelijk)
Contacten en locaties
Studie Locaties
-
-
Ontario
-
Hamilton, Ontario, Canada, L8R 3H6
- McMaster University
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
Inclusion Criteria:
- Adult females
- Patients presenting to participating fracture clinics within 6 weeks of their musculoskeletal injury
- Patients presenting with a fracture or dislocation which is being managed with either surgical or non-surgical treatment
Exclusion Criteria:
- Unwilling to or unable to provide consent
- Unable to complete the study questionnaires in a private location
- Unwilling or unable to follow the study protocol or their attending surgeon has concerns about their ability or willingness to follow study protocols
- Does not speak and write in English or the dominant language of the local clinic
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
---|---|
Experienced abuse
Experienced IPV in the past 12 months
|
|
Did not experience abuse
Did not experience IPV in the past 12 months.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Feasibility - Recruitment rate
Tijdsspanne: 12 months
|
Number of patients recruited at each site during a 12 month period
|
12 months
|
Feasibility - Proportion of Missed and/or out of window visits
Tijdsspanne: 12 months
|
Proportion of missed and out of window visits
|
12 months
|
Feasibility - Collection of secondary outcomes (Proportion of included patients followed at 12 months for the primary and secondary outcomes)
Tijdsspanne: 12 months
|
Proportion of included patients followed at 12 months for the primary and secondary outcomes
|
12 months
|
Feasibility - Completion of data collection (proportion of case report forms, including patient questionnaires, completed at 12 months)
Tijdsspanne: 12 months
|
The proportion of case report forms, including patient questionnaires, completed at 12 months.
|
12 months
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Proportion of patients with injury-related complications assessed by central adjudication
Tijdsspanne: 12 months
|
Compare proportion of patients experiencing a composite of injury-related complications between patients who self-report a history of IPV and those who do not.
Injury-related complications include non-union, malunion, infection, unplanned secondary procedure, mortality, hardware failure, etc.
An independent, blinded adjudicator will determine whether the event is injury-related.
|
12 months
|
Return to function questionnaire
Tijdsspanne: 12 months
|
We will use the Return to Function Questionnaire (RTF) to compare the mean time to return to pre-injury function among women who disclose a history of IPV versus those who do not disclose IPV.
The RTF is a 4 question tool that was used in a recently completed large FDA-regulated fracture trial.
|
12 months
|
IPV incidence questionnaire
Tijdsspanne: 12 months
|
Women's self-reported experience of IPV will be measured using a direct method of screening used by the PRAISE Investigators in 2 previous studies conducted in trauma populations.
A participant will be considered to have disclosed IPV if she answers positively to at least 1 of the 3 direct screening questions.
|
12 months
|
Resource use questionnaire
Tijdsspanne: 12 months
|
Women's access to and use of health and support services will be measured by directly asking participants to self-report if they have accessed health care services, a social worker, mental health professional, women's shelter, helpline, violence against women website, or legal assistance.
|
12 months
|
Quality of life - EQ-5D
Tijdsspanne: 12 months
|
Participants' quality of life will be measured using the EuroQol-5 Dimensions (EQ-5D), a widely used and well-validated quality of life tool.
The EQ-5D is a comprehensive, 5-item compact health status classification and health state preference questionnaire.
|
12 months
|
IPV frequency questionnaire
Tijdsspanne: 12 months
|
Using 3 questions from the Woman Abuse Screening Tool, which categorizes frequency of different types of violence, we will record and analyze changes in frequency of IPV experienced over time.
|
12 months
|
Stage of change questionnaire
Tijdsspanne: 12 months
|
Participants will complete the Domestic Violence Survivor Assessment (DVSA) Short Form questionnaire to determine her stage of change.
The stages of change are based on the transtheoretical model of health behavior change applied specifically to survivors of abuse.
We developed the DVSA Short Form for the purpose of this study, with the aim of making the self-administered form more accessible.
|
12 months
|
IPV type questionnaire
Tijdsspanne: 12 months
|
Using 3 questions from the Woman Abuse Screening Tool, which categorizes types of violence as physical, emotional, and/or sexual abuse, we will record and analyze changes in type of IPV experienced over time.
|
12 months
|
Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Brad Petrisor, MD, MSc, Hamilton Health Sciences Corporation
Publicaties en nuttige links
Algemene publicaties
- PRAISE Investigators; Sprague S, Bhandari M, Della Rocca GJ, Goslings JC, Poolman RW, Madden K, Simunovic N, Dosanjh S, Schemitsch EH. Prevalence of abuse and intimate partner violence surgical evaluation (PRAISE) in orthopaedic fracture clinics: a multinational prevalence study. Lancet. 2013 Sep 7;382(9895):866-76. doi: 10.1016/S0140-6736(13)61205-2. Epub 2013 Jun 12.
- Madden K; PRAISE-2 Investigators. Prospective evaluation of intimate partner violence in fracture clinics (PRAISE-2): protocol for a multicentre pilot prospective cohort study. Pilot Feasibility Stud. 2018 Jun 15;4:115. doi: 10.1186/s40814-018-0301-9. eCollection 2018.
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- PRAISE-2
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