IHEAL Trial: Effectiveness of a Health Promotion Intervention for Women Who Have Experienced Intimate Partner Violence

Intimate Partner Violence Clinical Trial

Official title:

iHEAL in Context: Effectiveness of a Health Promotion Intervention for Women Who Have Experienced Intimate Partner Violence (iHEAL Trial)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03573778
• Other study ID #: 111191
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 26, 2018
• Est. completion date: May 22, 2021

Study information

• Verified date: April 2021
• Source: Western University, Canada
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Living with an abusive partner has many negative impacts on women's health, safety and the quality of their lives. These issues often continue when women separate, or take steps to separate, from an abusive partner, and can make it more difficult to create a new life. However, few supports are available to help women manage their health and other challenges around the time of separation.

The Intervention for Health Enhancement and Living (iHEAL) was specifically developed to support women at this time. In iHEAL, women work with a Registered Nurse on issues that affect that their health and well-being in 10 and 18 visits that take place in a safe, private location over a 6 month period. The woman decides which issues she would like to work on, with nurses providing personalized help and support that fits with the woman's needs, goals and wishes. This includes helping her connect to local services if she chooses.

The purpose of this study is to learn whether iHEAL can improve the health and quality of life of women who have separated, or are taking steps to separate, from an abusive partner. To do this, 280 Canadian women from 3 provinces will be offered either iHEAL nurse visits or information about community services that they can use on their own. All participants will complete online surveys when they first start the study and 6 12, and 18 months later to examine whether there are changes in their health, quality of life, confidence and/or control. We also want to learn whether iHEAL is more helpful for some groups of women and whether any benefits to women that are identified outweigh the costs of providing the intervention. A small group of ~30-40 women will be asked to take part in an interview about what is was like to take part in this study when they complete the trial so that we can learn how to further improve iHEAL.

Description:

As above

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 331
• Est. completion date: May 22, 2021
• Est. primary completion date: April 24, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• Woman

• 19 years of age or older

• Able to speak, read and understand English

• Residing in specific communities in Ontario, British Columbia or New Brunswick

• Planning to remain in area for next 6 months

• Experienced physical, sexual, and/or psychological abuse, including coercive control from a current or former partner in the previous 12 months

• Planning to separate OR in the process of separating OR separated from an abusive partner in the previous 3 years

• Has access to the internet, and a safe computer, tablet, or smart phone

• Has a safe email address

Exclusion Criteria:

• Man

• Under 19 years of age

• Cannot read, speak, understand English

• Living outside of the selected study sites, or living in the area but planning to relocate within 6 months

• No experience of physical, sexual, or psychological abuse, including coercive control, from a current or former partner in the previous 12 months

• Planning to stay with an abusive partner OR separated more than 3 years ago

• No access to the internet, or safe computer, tablet or smart phone

• No access to safe email and mailing address

Related Conditions & MeSH terms

• Intimate Partner Violence

Intervention

Behavioral:
• iHEAL
Women work with a Registered Nurse in 10-18 visits (over 6 months) that focus on 6 inter-related 6 components (areas): Safeguarding, Managing Symptoms, Getting Basics, Cautiously Connecting, Regenerating Family, Renewing Self. Using a standard 3 phase process, and guided by 5 principles, the nurse discusses each of these components with the woman in order to identify the woman's needs, experiences and priorities. The nurse then provides personalized support to assist the woman in address the concerns that she sees as most important for her health and well-being; this support includes linking women to existing services if she chooses.
• Information about Community Services
Women are provided with information about community services appropriate for women experiencing intimate partner violence and consistent with what service providers might recommend (usual care). Women are encouraged to use this information as they see fit.

Locations

Country	Name	City	State
Canada	University of New Brunswick	Fredericton	New Brunswick
Canada	Western University	London	Ontario
Canada	University of British Columbia	Vancouver	British Columbia

Sponsors (7)

Lead Sponsor	Collaborator
Western University, Canada	Johns Hopkins University, McMaster University, Public Health Agency of Canada (PHAC), Université de Montréal, University of British Columbia, University of New Brunswick

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Severity of Intimate Partner Violence on the Composite Abuse Scale Revised - Short Form (CASr-SF)	15 item validated measure of severity of intimate partner violence	Baseline, 6, 12, 18 months
Other	Problem Drinking on the AUDIT	Self-report measure of alcohol mis-use	Baseline, 6, 12, 18 months
Primary	Changes in Quality of Life on the Quality of Life Scale (Sullivan)	9 item self-report measure developed to assess quality of life across domains important to women who have experienced intimate partner violence. Total scores range from 9 to 63. Higher scores reflect higher levels of quality of life.	baseline, 6 months
Primary	Changes in PTSD Symptomology on the PTSD Checklist (Civilian Version)	17 item self-report measure of PTSD symptoms designed for use in community samples and to assess probability of meeting diagnostic criteria for PTSD.	baseline, 6 months
Secondary	Changes in Quality of Life on the Quality of Life Scale (Sullivan)	9 item self-report measure developed to assess quality of life across domains important to women who have experienced intimate partner violence	baseline, 12 months
Secondary	Changes in Quality of Life on the Quality of Life Scale (Sullivan)	9 item self-report measure developed to assess quality of life across domains important to women who have experienced intimate partner violence	Baseline, 18 months
Secondary	Changes in PTSD Symptomology on the PTSD Checklist (Civilian Version)	17 item self-report measure of PTSD symptoms designed for use in community samples and to assess probability of meeting diagnostic criteria for PTSD	Baseline, 12 months
Secondary	Changes in PTSD Symptomology on the PTSD Checklist (Civilian Version)	17 item self-report measure of PTSD symptoms designed for use in community samples and to assess probability of meeting diagnostic criteria for PTSD	Baseline, 18 months
Secondary	Changes in Depressive Symptoms on the Center for Epidemiologic Studies Depression Scale, Revised (CESD-R).	20 item self-report measure of depressive symptoms in community samples, including probability of meeting criteria for major depressive disorder. Total scores range from 0 to 60. Higher scores reflect higher levels of depressive symptoms.	Baseline, 6 months
Secondary	Changes in Depressive Symptoms on the Center for Epidemiologic Studies Depression Scale, Revised	20 item self-report measure of depressive symptoms in community samples, including probability of meeting criteria for major depressive disorder	Baseline, 12 months
Secondary	Changes in Depressive Symptoms on the Center for Epidemiologic Studies Depression Scale, Revised	20 item self-report measure of depressive symptoms in community samples, including probability of meeting criteria for major depressive disorder	Baseline, 18 months
Secondary	Changes in Chronic Pain Disability on the Chronic Pain Grade (van Korff)	7 item self-report measure of chronic pain intensity and disability, including 4 "grades" that capture level of disability (from no to high)	Baseline, 6 months
Secondary	Changes in Chronic Pain Disability on the Chronic Pain Grade (van Korff)	7 item self-report measure of chronic pain intensity and disability, including 4 "grades" that capture level of disability (from no to high)	Baseline, 12 months
Secondary	Changes in Chronic Pain Disability on the Chronic Pain Grade (van Korff)	7 item self-report measure of chronic pain intensity and disability, including 4 "grades" that capture level of disability (from no to high)	Baseline, 18 months
Secondary	Changes in Personal Control on the Personal Agency Scale (Smith)	8 item self-report scale that measures an individual's sense of control and efforts to act on their own behalf. Total scores range from 8 to 32. Higher scores reflect higher levels of personal agency.	Baseline, 6 months
Secondary	Changes in Personal Control on the Personal Agency Scale (Smith)	8 item self-report scale that measures an individual's sense of control and efforts to act on their own behalf. Total scores range from 8 to 32. Higher scores reflect higher levels of personal agency.	Baseline, 12 months
Secondary	Changes in Personal Control on the Personal Agency Scale (Smith)	8 item self-report scale that measures an individual's sense of control and efforts to act on their own behalf. Total scores range from 8 to 32. Higher scores reflect higher levels of personal agency.	Baseline, 18 months
Secondary	Changes in Confidence (self-efficacy) on investigator-developed scale	10 item self-report scale that measures women's confidence in engaging in a set of actions that fit with key goals of the iHEAL on 100 mm visual analogue scales. total scores range from 0 to 100. Higher scores reflect higher levels of confidence.	Baseline, 6 months
Secondary	Changes in Confidence (self-efficacy) on investigator-developed scale	10 item self-report scale that measures women's confidence in engaging in a set of actions that fit with key goals of the iHEAL on 100 mm visual analogue scales. Total scores range from 0 to 100. Higher scores reflected higher levels of confidence.	Baseline, 12 months
Secondary	Changes in Confidence (self-efficacy) on investigator-developed scale	10 item self-report scale that measures women's confidence in engaging in a set of actions that fit with key goals of the iHEAL on 100 mm visual analogue scales. Total scores range from 0 -100. Higher scores reflect higher levels of confidence.	Baseline, 18 months
Secondary	Changes in Coercive Control on the Women's Experiences of Battering Scale (WEB)	10 item self-report measure of the intensity of coercive control experienced by women in response to intimate partner violence. Total scores range from 10 to 60. Higher scores reflect higher levels of experiences of coercive control.	Baseline, 6 months
Secondary	Changes in Coercive Control on the Women's Experiences of Battering Scale (WEB)	10 item self-report measure of the intensity of coercive control experienced by women in response to intimate partner violence. Total scores range from 10 to 60. Higher scores reflect higher levels of experiences of coercive control.	Baseline, 12 months
Secondary	Changes in Coercive Control on the Women's Experiences of Battering Scale (WEB)	10 item self-report measure of the intensity of coercive control experienced by women in response to intimate partner violence. Total scores range from 10-60. Higher scores reflect higher levels of experiences of coercive control.	Baseline, 18 months