Clinical trial NCT03573778: IHEAL Trial: Effectiveness of a Health Promotion Intervention for Women Who Have Experienced Intimate Partner Violence
Official title: iHEAL in Context: Effectiveness of a Health Promotion Intervention for Women Who Have Experienced Intimate Partner Violence (iHEAL Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intimate Partner Violence
Keywords: health
quality of life
safety
health promotion
intimate partner violence
domestic violence
confidence
control
nursing intervention
Lead sponsor: Western University, Canada
Sponsor class: OTHER
Collaborators: name: University of British Columbia
name: University of New Brunswick
name: McMaster University
name: Johns Hopkins University
name: Université de Montréal
name: Public Health Agency of Canada (PHAC)
First posted: 2018-06-29
Enrollment: 331
Sex: FEMALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled trial comparing active treatment to usual care
Primary purpose: PREVENTION

Brief 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.

Detailed description: For a detailed description of the study rationale, hypotheses, research questions and methods, please see:

Ford-Gilboe, M., Varcoe, C., Scott-Storey, K. et al. Longitudinal effectiveness of a woman-led, nurse delivered health promotion intervention for women who have experienced intimate partner violence: iHEAL randomized controlled trial. BMC Public Health 24, 398 (2024). https://doi.org/10.1186/s12889-023-17578-4.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in Quality of Life on the Quality of Life Scale (Sullivan)
timeFrame: baseline, 6 months
measure: Changes in PTSD Symptomology on the PTSD Checklist (Civilian Version)
timeFrame: baseline, 6 months
Secondary outcomes:
measure: Changes in Quality of Life on the Quality of Life Scale (Sullivan)
timeFrame: baseline, 12 months
measure: Changes in Quality of Life on the Quality of Life Scale (Sullivan)
timeFrame: Baseline, 18 months
measure: Changes in PTSD Symptomology on the PTSD Checklist (Civilian Version)
timeFrame: Baseline, 12 months
measure: Changes in PTSD Symptomology on the PTSD Checklist (Civilian Version)
timeFrame: Baseline, 18 months
measure: Changes in Depressive Symptoms on the Center for Epidemiologic Studies Depression Scale, Revised (CESD-R).
timeFrame: Baseline, 6 months
measure: Changes in Depressive Symptoms on the Center for Epidemiologic Studies Depression Scale, Revised
timeFrame: Baseline, 12 months
measure: Changes in Depressive Symptoms on the Center for Epidemiologic Studies Depression Scale, Revised
timeFrame: Baseline, 18 months
measure: Changes in Chronic Pain Disability on the Chronic Pain Grade (van Korff)
timeFrame: Baseline, 6 months
measure: Changes in Chronic Pain Disability on the Chronic Pain Grade (van Korff)
timeFrame: Baseline, 12 months
measure: Changes in Chronic Pain Disability on the Chronic Pain Grade (van Korff)
timeFrame: Baseline, 18 months
measure: Changes in Personal Control on the Personal Agency Scale (Smith)
timeFrame: Baseline, 6 months
measure: Changes in Personal Control on the Personal Agency Scale (Smith)
timeFrame: Baseline, 12 months
measure: Changes in Personal Control on the Personal Agency Scale (Smith)
timeFrame: Baseline, 18 months
measure: Changes in Confidence (self-efficacy) on investigator-developed scale
timeFrame: Baseline, 6 months
measure: Changes in Confidence (self-efficacy) on investigator-developed scale
timeFrame: Baseline, 12 months
measure: Changes in Confidence (self-efficacy) on investigator-developed scale
timeFrame: Baseline, 18 months
measure: Changes in Coercive Control on the Women's Experiences of Battering Scale (WEB)
timeFrame: Baseline, 6 months
measure: Changes in Coercive Control on the Women's Experiences of Battering Scale (WEB)
timeFrame: Baseline, 12 months
measure: Changes in Coercive Control on the Women's Experiences of Battering Scale (WEB)
timeFrame: Baseline, 18 months
Other outcomes:
measure: Severity of Intimate Partner Violence on the Composite Abuse Scale Revised - Short Form (CASr-SF)
timeFrame: Baseline, 6, 12, 18 months
measure: Problem Drinking on the AUDIT
timeFrame: Baseline, 6, 12, 18 months
Locations:
city: Vancouver
country: Canada
facility: University of British Columbia
state: British Columbia
city: Fredericton
country: Canada
facility: University of New Brunswick
state: New Brunswick
city: London
country: Canada
facility: Western University
state: Ontario
Study officials:
affiliation: Western University
name: Marilyn Ford-Gilboe, PhD
role: PRINCIPAL_INVESTIGATOR
References: