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

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

331 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-26

Study Completion Date

2021-05-22

Brief Summary

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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

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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.

Conditions

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Intimate Partner Violence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized Controlled trial comparing active treatment to usual care
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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iHEAL

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

Group Type EXPERIMENTAL

iHEAL

Intervention Type 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.

Usual Care

Information about Community Services

Group Type ACTIVE_COMPARATOR

Information about Community Services

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of British Columbia

OTHER

Sponsor Role collaborator

University of New Brunswick

OTHER

Sponsor Role collaborator

McMaster University

OTHER

Sponsor Role collaborator

Johns Hopkins University

OTHER

Sponsor Role collaborator

Université de Montréal

OTHER

Sponsor Role collaborator

Public Health Agency of Canada (PHAC)

OTHER_GOV

Sponsor Role collaborator

Western University, Canada

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marilyn Ford-Gilboe, PhD

Role: PRINCIPAL_INVESTIGATOR

Western University

Locations

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University of British Columbia

Vancouver, British Columbia, Canada

Site Status

University of New Brunswick

Fredericton, New Brunswick, Canada

Site Status

Western University

London, Ontario, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type DERIVED
PMID: 38326832 (View on PubMed)

Other Identifiers

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111191

Identifier Type: -

Identifier Source: org_study_id

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