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

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ClinicalTrials.gov Identifier: NCT03573778
Recruitment Status : Recruiting
First Posted : June 29, 2018
Last Update Posted : October 4, 2018
Sponsor:
Collaborators:
University of British Columbia
University of New Brunswick
McMaster University
Johns Hopkins University
Université de Montréal
Public Health Agency of Canada (PHAC)
Information provided by (Responsible Party):
Western University, Canada

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.


Condition or disease Intervention/treatment Phase
Intimate Partner Violence Behavioral: iHEAL Behavioral: Information about Community Services Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 280 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized Controlled trial comparing active treatment to usual care
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: iHEAL in Context: Effectiveness of a Health Promotion Intervention for Women Who Have Experienced Intimate Partner Violence (iHEAL Trial)
Actual Study Start Date : September 26, 2018
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : May 2020

Arm Intervention/treatment
Experimental: iHEAL
10-18 visits (over 6 months) with a Registered Nurse
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.

Active Comparator: Usual Care
Information about Community Services
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.




Primary Outcome Measures :
  1. Changes in Quality of Life on the Quality of Life Scale (Sullivan) [ Time Frame: 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.

  2. Changes in PTSD Symptomology on the PTSD Checklist (Civilian Version) [ Time Frame: 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.


Secondary Outcome Measures :
  1. Changes in Quality of Life on the Quality of Life Scale (Sullivan) [ Time Frame: baseline, 12 months ]
    9 item self-report measure developed to assess quality of life across domains important to women who have experienced intimate partner violence

  2. Changes in Quality of Life on the Quality of Life Scale (Sullivan) [ Time Frame: Baseline, 18 months ]
    9 item self-report measure developed to assess quality of life across domains important to women who have experienced intimate partner violence

  3. Changes in PTSD Symptomology on the PTSD Checklist (Civilian Version) [ Time Frame: Baseline, 12 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

  4. Changes in PTSD Symptomology on the PTSD Checklist (Civilian Version) [ Time Frame: Baseline, 18 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

  5. Changes in Depressive Symptoms on the Center for Epidemiologic Studies Depression Scale, Revised (CESD-R). [ Time Frame: Baseline, 6 months ]
    20 item self-report measure of depressive symptoms in community samples, including probability of meeting criteria for major depressive disorder. Total scores range from 0 to 60. Higher scores reflect higher levels of depressive symptoms.

  6. Changes in Depressive Symptoms on the Center for Epidemiologic Studies Depression Scale, Revised [ Time Frame: Baseline, 12 months ]
    20 item self-report measure of depressive symptoms in community samples, including probability of meeting criteria for major depressive disorder

  7. Changes in Depressive Symptoms on the Center for Epidemiologic Studies Depression Scale, Revised [ Time Frame: Baseline, 18 months ]
    20 item self-report measure of depressive symptoms in community samples, including probability of meeting criteria for major depressive disorder

  8. Changes in Chronic Pain Disability on the Chronic Pain Grade (van Korff) [ Time Frame: Baseline, 6 months ]
    7 item self-report measure of chronic pain intensity and disability, including 4 "grades" that capture level of disability (from no to high)

  9. Changes in Chronic Pain Disability on the Chronic Pain Grade (van Korff) [ Time Frame: Baseline, 12 months ]
    7 item self-report measure of chronic pain intensity and disability, including 4 "grades" that capture level of disability (from no to high)

  10. Changes in Chronic Pain Disability on the Chronic Pain Grade (van Korff) [ Time Frame: Baseline, 18 months ]
    7 item self-report measure of chronic pain intensity and disability, including 4 "grades" that capture level of disability (from no to high)

  11. Changes in Personal Control on the Personal Agency Scale (Smith) [ Time Frame: Baseline, 6 months ]
    8 item self-report scale that measures an individual's sense of control and efforts to act on their own behalf. Total scores range from 8 to 32. Higher scores reflect higher levels of personal agency.

  12. Changes in Personal Control on the Personal Agency Scale (Smith) [ Time Frame: Baseline, 12 months ]
    8 item self-report scale that measures an individual's sense of control and efforts to act on their own behalf. Total scores range from 8 to 32. Higher scores reflect higher levels of personal agency.

  13. Changes in Personal Control on the Personal Agency Scale (Smith) [ Time Frame: Baseline, 18 months ]
    8 item self-report scale that measures an individual's sense of control and efforts to act on their own behalf. Total scores range from 8 to 32. Higher scores reflect higher levels of personal agency.

  14. Changes in Confidence (self-efficacy) on investigator-developed scale [ Time Frame: Baseline, 6 months ]
    10 item self-report scale that measures women's confidence in engaging in a set of actions that fit with key goals of the iHEAL on 100 mm visual analogue scales. total scores range from 0 to 100. Higher scores reflect higher levels of confidence.

  15. Changes in Confidence (self-efficacy) on investigator-developed scale [ Time Frame: Baseline, 12 months ]
    10 item self-report scale that measures women's confidence in engaging in a set of actions that fit with key goals of the iHEAL on 100 mm visual analogue scales. Total scores range from 0 to 100. Higher scores reflected higher levels of confidence.

  16. Changes in Confidence (self-efficacy) on investigator-developed scale [ Time Frame: Baseline, 18 months ]
    10 item self-report scale that measures women's confidence in engaging in a set of actions that fit with key goals of the iHEAL on 100 mm visual analogue scales. Total scores range from 0 -100. Higher scores reflect higher levels of confidence.

  17. Changes in Coercive Control on the Women's Experiences of Battering Scale (WEB) [ Time Frame: Baseline, 6 months ]
    10 item self-report measure of the intensity of coercive control experienced by women in response to intimate partner violence. Total scores range from 10 to 60. Higher scores reflect higher levels of experiences of coercive control.

  18. Changes in Coercive Control on the Women's Experiences of Battering Scale (WEB) [ Time Frame: Baseline, 12 months ]
    10 item self-report measure of the intensity of coercive control experienced by women in response to intimate partner violence. Total scores range from 10 to 60. Higher scores reflect higher levels of experiences of coercive control.

  19. Changes in Coercive Control on the Women's Experiences of Battering Scale (WEB) [ Time Frame: Baseline, 18 months ]
    10 item self-report measure of the intensity of coercive control experienced by women in response to intimate partner violence. Total scores range from 10-60. Higher scores reflect higher levels of experiences of coercive control.


Other Outcome Measures:
  1. Severity of Intimate Partner Violence on the Composite Abuse Scale Revised - Short Form (CASr-SF) [ Time Frame: Baseline, 6, 12, 18 months ]
    15 item validated measure of severity of intimate partner violence

  2. Problem Drinking on the AUDIT [ Time Frame: Baseline, 6, 12, 18 months ]
    Self-report measure of alcohol mis-use



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Identifies as a woman
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03573778


Contacts
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Contact: Joanne Project Manager 1-866-661-3343 admin@ihealstudy.ca

Locations
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Canada, British Columbia
University of British Columbia Recruiting
Vancouver, British Columbia, Canada, V6T 2B5
Contact: Joanne Project Manager    1-866-661-3343    admin@ihealstudy.ca   
Principal Investigator: Colleen Varcoe, PhD         
Canada, New Brunswick
University of New Brunswick Recruiting
Fredericton, New Brunswick, Canada
Contact: Joanne Project Manager    1-866-661-3343    admin@ihealstudy.ca   
Principal Investigator: Kelly Scott-Storey, PhD         
Canada, Ontario
Western University Recruiting
London, Ontario, Canada, N6A 3C1
Contact: Joanne Project Manager    1-866-661-3343    admin@ihealstudy.ca   
Principal Investigator: Marilyn Ford-Gilboe, PhD         
Sponsors and Collaborators
Western University, Canada
University of British Columbia
University of New Brunswick
McMaster University
Johns Hopkins University
Université de Montréal
Public Health Agency of Canada (PHAC)
Investigators
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Principal Investigator: Marilyn Ford-Gilboe, PhD Western University

Additional Information:
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Responsible Party: Western University, Canada
ClinicalTrials.gov Identifier: NCT03573778    
Other Study ID Numbers: 111191
First Posted: June 29, 2018    Key Record Dates
Last Update Posted: October 4, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Western University, Canada:
health
quality of life
safety
health promotion
intimate partner violence
domestic violence
confidence
control
nursing intervention