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

NCT03573778 | Completed DMC

• 1 other identifier: 111191
• Study Type: interventional
• Target: 331
• Locations: 1 country
• Sites: 3

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.

Conditions

Intimate Partner Violence

Keywords

health; quality of life; safety; health promotion; intimate partner violence; domestic violence; confidence; control; nursing intervention

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (19)

• Changes in Quality of Life on the Quality of Life Scale (Sullivan)

  baseline, 12 months

• Changes in Quality of Life on the Quality of Life Scale (Sullivan)

  Baseline, 18 months

• Changes in PTSD Symptomology on the PTSD Checklist (Civilian Version)

  Baseline, 12 months

• Changes in PTSD Symptomology on the PTSD Checklist (Civilian Version)

  Baseline, 18 months

• Changes in Depressive Symptoms on the Center for Epidemiologic Studies Depression Scale, Revised (CESD-R).

  Baseline, 6 months

Other Outcomes (2)

• Severity of Intimate Partner Violence on the Composite Abuse Scale Revised - Short Form (CASr-SF)

  Baseline, 6, 12, 18 months

• Problem Drinking on the AUDIT

  Baseline, 6, 12, 18 months

Study Arms (2)

iHEAL

EXPERIMENTAL

10-18 visits (over 6 months) with a Registered Nurse

Behavioral: iHEAL

Usual Care

ACTIVE COMPARATOR

Information about Community Services

Behavioral: Information about Community Services

Interventions

iHEAL BEHAVIORAL

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.

iHEAL

Information about Community Services BEHAVIORAL

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.

Usual Care

Eligibility Criteria

• Age: 19 Years+
• Gender Eligibility Details: Identifies as a woman
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Woman
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Western University, Canada: lead
• University of British Columbia: collaborator
• University of New Brunswick: collaborator
• McMaster University: collaborator
• Johns Hopkins University: collaborator
• Université de Montréal: collaborator
• Public Health Agency of Canada (PHAC): collaborator

Study Sites (3)

University of British Columbia

Vancouver, British Columbia, V6T 2B5, Canada

Location

University of New Brunswick

Fredericton, New Brunswick, Canada

Location

Western University

London, Ontario, N6A 3C1, Canada

Location

Related Publications (1)

• Ford-Gilboe M, Varcoe C, Scott-Storey K, Browne AJ, Jack SM, Jackson K, Mantler T, O'Donnell S, Patten-Lu N, Smye V, Wathen CN, Perrin N. 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. 2024 Feb 7;24(1):398. doi: 10.1186/s12889-023-17578-4.

  PMID: 38326832 DERIVED

Study Officials

• Marilyn Ford-Gilboe, PhD

  Western University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized Controlled trial comparing active treatment to usual care

Study Record Dates

• First Submitted: June 20, 2018
• First Posted: June 29, 2018
• Study Start: September 26, 2018
• Primary Completion: April 24, 2020
• Study Completion: May 22, 2021
• Last Updated: August 1, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (3)