Ignite Creation Date:
2025-12-25 @ 12:35 AM
Ignite Modification Date:
2026-01-22 @ 2:46 AM
Study NCT ID:
NCT02529267
Status:
UNKNOWN
Last Update Posted:
2018-06-26
First Post:
2015-08-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Abuse and Intimate Partner Violence Surgical Evaluation
Sponsor:
McMaster University
Organization:
Study Overview
Official Title:
Prospective Abuse and Intimate Partner Violence Surgical Evaluation (PRAISE-2) : A Multicentre Pilot Prospective Cohort Study
Status:
UNKNOWN
Status Verified Date:
2018-06
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PRAISE-2
Brief Summary:
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.
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: