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

NCT03573778 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 331

Last updated 2024-08-01

No results posted yet for this study

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

Interventions

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.

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.

Sponsors & Collaborators

  • University of British Columbia

    collaborator OTHER
  • University of New Brunswick

    collaborator OTHER
  • McMaster University

    collaborator OTHER
  • Johns Hopkins University

    collaborator OTHER
  • Université de Montréal

    collaborator OTHER
  • Public Health Agency of Canada (PHAC)

    collaborator OTHER_GOV
  • Western University, Canada

    lead OTHER

Principal Investigators

  • Marilyn Ford-Gilboe, PhD · Western University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-09-26
Primary Completion
2020-04-24
Completion
2021-05-22

Countries

  • Canada

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03573778 on ClinicalTrials.gov