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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Intimate Partner Violence
• Intervention / Treatment: Behavioral: iHEAL; Behavioral: Information about Community Services

Detailed Description

As above

• Study Type: Interventional
• Enrollment (Actual): 331
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V6T 2B5
      • University of British Columbia
  • New Brunswick
    • Fredericton, New Brunswick, Canada
      • University of New Brunswick
  • Ontario
    • London, Ontario, Canada, N6A 3C1
      • Western University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: iHEAL; 10-18 visits (over 6 months) with a Registered Nurse	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.
Active Comparator: Usual Care; Information about Community Services	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Problem Drinking on the AUDIT	Self-report measure of alcohol mis-use	Baseline, 6, 12, 18 months

Collaborators and Investigators

• Sponsor: Western University, Canada
• Collaborators: Johns Hopkins University; University of British Columbia; McMaster University; University of New Brunswick; Université de Montréal; Public Health Agency of Canada (PHAC)
• Investigators: Principal Investigator: Marilyn Ford-Gilboe, PhD, Western University

Study record dates

Study Major Dates

• Study Start (Actual): September 26, 2018
• Primary Completion (Actual): April 24, 2020
• Study Completion (Anticipated): May 22, 2021

Study Registration Dates

• First Submitted: June 20, 2018
• First Submitted That Met QC Criteria: June 20, 2018
• First Posted (Actual): June 29, 2018

Study Record Updates

• Last Update Posted (Actual): April 28, 2021
• Last Update Submitted That Met QC Criteria: April 26, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: health; safety; quality of life; control; domestic violence; health promotion; intimate partner violence; nursing intervention; confidence
• Other Study ID Numbers: 111191

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No