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临床试验/NCT03573778
NCT03573778已完成不适用

iHEAL in Context: Effectiveness of a Health Promotion Intervention for Women Who Have Experienced Intimate Partner Violence (iHEAL Trial)

Western University, Canada5 个研究点 分布在 1 个国家目标入组 331 人开始时间: 2018年9月26日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
331
试验地点
5
主要终点
Changes in PTSD Symptomology on the PTSD Checklist (Civilian Version)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
19 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

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

时间窗: baseline, 6 months

17 item self-report measure of PTSD symptoms designed for use in community samples and to assess probability of meeting diagnostic criteria for PTSD.

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

时间窗: baseline, 6 months

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.

次要结局

  • Changes in Depressive Symptoms on the Center for Epidemiologic Studies Depression Scale, Revised (CESD-R).(Baseline, 6 months)
  • Changes in Chronic Pain Disability on the Chronic Pain Grade (van Korff)(Baseline, 18 months)
  • Changes in Personal Control on the Personal Agency Scale (Smith)(Baseline, 18 months)
  • Changes in PTSD Symptomology on the PTSD Checklist (Civilian Version)(Baseline, 18 months)
  • Changes in Confidence (self-efficacy) on investigator-developed scale(Baseline, 18 months)
  • Changes in Coercive Control on the Women's Experiences of Battering Scale (WEB)(Baseline, 18 months)
  • Changes in Quality of Life on the Quality of Life Scale (Sullivan)(Baseline, 18 months)
  • Changes in Depressive Symptoms on the Center for Epidemiologic Studies Depression Scale, Revised(Baseline, 18 months)

研究者

发起方
Western University, Canada
申办方类型
Other
责任方
Sponsor

研究点 (5)

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