IHEAL Trial: Effectiveness of a Health Promotion Intervention for Women Who Have Experienced Intimate Partner Violence
NCT ID: NCT03573778
Last Updated: 2024-08-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
331 participants
INTERVENTIONAL
2018-09-26
2021-05-22
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Does Routine Screening for Intimate Partner Violence Against Women in Health Care Settings do More Good Than Harm?
NCT00182468
Identification of Interpesonal Violence
NCT06322251
Effectiveness of an Online Safety Tool for Canadian Women Experiencing Intimate Partner Violence
NCT02258841
Telephone Intervention to Increase Safety in Abused Women
NCT00457522
Motivational Interviewing Intervention for Intimate Partner Violence
NCT01410669
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
iHEAL
10-18 visits (over 6 months) with a Registered Nurse
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.
Usual Care
Information about Community Services
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
19 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of British Columbia
OTHER
University of New Brunswick
OTHER
McMaster University
OTHER
Johns Hopkins University
OTHER
Université de Montréal
OTHER
Public Health Agency of Canada (PHAC)
OTHER_GOV
Western University, Canada
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Marilyn Ford-Gilboe, PhD
Role: PRINCIPAL_INVESTIGATOR
Western University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of British Columbia
Vancouver, British Columbia, Canada
University of New Brunswick
Fredericton, New Brunswick, Canada
Western University
London, Ontario, Canada
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
111191
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.