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Prospective Abuse and Intimate Partner Violence Surgical Evaluation (PRAISE-2)

25. Juni 2018 aktualisiert von: McMaster University

Prospective Abuse and Intimate Partner Violence Surgical Evaluation (PRAISE-2) : A Multicentre Pilot Prospective Cohort Study

Intimate partner violence (IPV), also known as domestic abuse, is a leading cause of non-fatal injury in women worldwide. 1 in 6 women attending surgical fracture clinics have a history of IPV in the past year. Given the high prevalence and costs associated with IPV, there is a need to identify health outcomes associated with IPV, the incidence of new and worsening cases of IPV, and resource use among IPV victims. This prospective cohort study of women with fractures and dislocations will assess differences in injury-related outcomes (time to fracture healing, injury-related complications, and return to pre-injury function) between abused and non-abused women. This study will also determine whether a musculoskeletal injury can lead to new or worsening abuse by an intimate partner and how patterns of IPV change over time following musculoskeletal injuries.Finally, the proposed study will also inform the feasibility of a larger multinational cohort study.

Studienübersicht

Status

Unbekannt

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

Number of Participants:

250

Primary Research Objectives:

Feasibility

Secondary Research Objective:

The secondary objectives are to determine:

  1. How a history of IPV affects injury-related complications;
  2. How a history of IPV affects return to pre-injury function;
  3. Incident cases of IPV after a musculoskeletal injury, if the injury was not the result of IPV;
  4. How a history of IPV affects health care and support service use after a musculoskeletal injury;
  5. How a history of IPV affects health-related quality of life after a musculoskeletal injury;
  6. How patterns of IPV change over time after a musculoskeletal injury;
  7. How abused women's stage of change changes over time after a musculoskeletal injury

Diagnosis and Main Inclusion Criteria:

The inclusion criteria are:

  1. adult females (at least 16 or 18 years of age depending on local ethics requirements);
  2. patients presenting to participating fracture clinics within 6 weeks of their musculoskeletal injury;
  3. patients presenting with a fracture or dislocation which is being managed with either surgical or non-surgical treatment.

The exclusion criteria are:

  1. unwilling to or unable to provide consent;
  2. unable to complete the study questionnaires in a private location, due to safety and confidentiality;
  3. unwilling or unable to follow the study protocol or their attending surgeon has concerns about their ability or willingness to follow study protocols;
  4. 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

Studientyp

Beobachtungs

Einschreibung (Tatsächlich)

250

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Kanada
    • Ontario
      • Hamilton, Ontario, Kanada, L8R 3H6
        • McMaster University

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

16 Jahre und älter (Kind, Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Weiblich

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

Adult women presenting to participating fracture clinics with a fracture or dislocation.

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
Intervention / Behandlung
Experienced abuse
Experienced IPV in the past 12 months
Sonstiges: Pflegestandard
Did not experience abuse
Did not experience IPV in the past 12 months.
Sonstiges: Pflegestandard

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Feasibility - Recruitment rate
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 12 months
The proportion of case report forms, including patient questionnaires, completed at 12 months.
12 months

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Proportion of patients with injury-related complications assessed by central adjudication
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

McMaster University

Mitarbeiter

Canadian Institutes of Health Research (CIHR)
The Physicians' Services Incorporated Foundation

Ermittler

  • Hauptermittler: Brad Petrisor, MD, MSc, Hamilton Health Sciences Corporation

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. August 2015

Primärer Abschluss (Voraussichtlich)

1. Juni 2019

Studienabschluss (Voraussichtlich)

1. Juni 2019

Studienanmeldedaten

Zuerst eingereicht

7. August 2015

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

19. August 2015

Zuerst gepostet (Schätzen)

20. August 2015

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

26. Juni 2018

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

25. Juni 2018

Zuletzt verifiziert

1. Juni 2018

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • PRAISE-2

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