Intimate Partner ViolenceNCT03573778
IHEAL Trial: Effectiveness of a Health Promotion Intervention for Women Who Have Experienced Intimate Partner Violence
A study testing iHEAL and Information about Community Services in people with Intimate Partner Violence, run by Western University, Canada at 3 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Intimate Partner Violence
- What is being tested?
- iHEAL and Information about Community Services
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 331 participants
- Where
- 3 sitesCanada
- Study dates
- 26 Sep 2018to 22 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
University of New Brunswick
Fredericton, New Brunswick
Western University
London, Ontario, N6A 3C1
University of British Columbia
Vancouver, British Columbia, V6T 2B5
About this study
Official title: iHEAL in Context: Effectiveness of a Health Promotion Intervention for Women Who Have Experienced Intimate Partner Violence (iHEAL Trial)
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.
Read the detailed description
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
- Intimate Partner Violence
- Being tested
- iHEAL, Information about Community Services
- Keywords
- health, quality of life, safety, health promotion, intimate partner violence, domestic violence, confidence, control, nursing intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iHEALBehavioural
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 ServicesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| iHEAL | Experimental | 10-18 visits (over 6 months) with a Registered Nurse Receives: Behavioral: iHEAL |
| Usual Care | Active comparator | Information about Community Services Receives: Behavioral: Information about Community Services |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Quality of Life on the Quality of Life Scale (Sullivan)
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.
Measured: baseline, 6 months
Changes in PTSD Symptomology on the PTSD Checklist (Civilian Version)
17 item self-report measure of PTSD symptoms designed for use in community samples and to assess probability of meeting diagnostic criteria for PTSD.
Measured: baseline, 6 months
Secondary outcomes (19)
Changes in Quality of Life on the Quality of Life Scale (Sullivan)
9 item self-report measure developed to assess quality of life across domains important to women who have experienced intimate partner violence
Measured: baseline, 12 months
Changes in Quality of Life on the Quality of Life Scale (Sullivan)
9 item self-report measure developed to assess quality of life across domains important to women who have experienced intimate partner violence
Measured: Baseline, 18 months
Changes in PTSD Symptomology on the PTSD Checklist (Civilian Version)
17 item self-report measure of PTSD symptoms designed for use in community samples and to assess probability of meeting diagnostic criteria for PTSD
Measured: Baseline, 12 months
Changes in PTSD Symptomology on the PTSD Checklist (Civilian Version)
17 item self-report measure of PTSD symptoms designed for use in community samples and to assess probability of meeting diagnostic criteria for PTSD
Measured: Baseline, 18 months
Changes in Depressive Symptoms on the Center for Epidemiologic Studies Depression Scale, Revised (CESD-R).
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.
Measured: Baseline, 6 months
Changes in Depressive Symptoms on the Center for Epidemiologic Studies Depression Scale, Revised
20 item self-report measure of depressive symptoms in community samples, including probability of meeting criteria for major depressive disorder
Measured: Baseline, 12 months
Changes in Depressive Symptoms on the Center for Epidemiologic Studies Depression Scale, Revised
20 item self-report measure of depressive symptoms in community samples, including probability of meeting criteria for major depressive disorder
Measured: Baseline, 18 months
Changes in Chronic Pain Disability on the Chronic Pain Grade (van Korff)
7 item self-report measure of chronic pain intensity and disability, including 4 "grades" that capture level of disability (from no to high)
Measured: Baseline, 6 months
Changes in Chronic Pain Disability on the Chronic Pain Grade (van Korff)
7 item self-report measure of chronic pain intensity and disability, including 4 "grades" that capture level of disability (from no to high)
Measured: Baseline, 12 months
Changes in Chronic Pain Disability on the Chronic Pain Grade (van Korff)
7 item self-report measure of chronic pain intensity and disability, including 4 "grades" that capture level of disability (from no to high)
Measured: Baseline, 18 months
Changes in Personal Control on the Personal Agency Scale (Smith)
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.
Measured: Baseline, 6 months
Changes in Personal Control on the Personal Agency Scale (Smith)
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.
Measured: Baseline, 12 months
Changes in Personal Control on the Personal Agency Scale (Smith)
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.
Measured: Baseline, 18 months
Changes in Confidence (self-efficacy) on investigator-developed scale
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.
Measured: Baseline, 6 months
Changes in Confidence (self-efficacy) on investigator-developed scale
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.
Measured: Baseline, 12 months
Changes in Confidence (self-efficacy) on investigator-developed scale
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.
Measured: Baseline, 18 months
Changes in Coercive Control on the Women's Experiences of Battering Scale (WEB)
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.
Measured: Baseline, 6 months
Changes in Coercive Control on the Women's Experiences of Battering Scale (WEB)
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.
Measured: Baseline, 12 months
Changes in Coercive Control on the Women's Experiences of Battering Scale (WEB)
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.
Measured: Baseline, 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2018
- Study start26 Sep 2018
- Primary completion24 Apr 2020
- Study completion22 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intimate Partner ViolenceStudies of the same condition, open and under way.
- More trials run by Western University, CanadaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled trial comparing active treatment to usual care
- Masking
- None (open label)
- Enrolment
- 331 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western University, Canada
- Sponsor type
- University, hospital or other
- Collaborators
- University of British Columbia, University of New Brunswick, McMaster University, Johns Hopkins University, Université de Montréal, Public Health Agency of Canada (PHAC)
- Responsible party
- Sponsor
- Investigators
- Marilyn Ford-Gilboe, PhD, Principal investigator, Western University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03573778
- Sponsor's protocol ID
- 111191
- Status last verified
- Jul 2024
- First submitted
- 20 Jun 2018
- Last updated
- 1 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38326832
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- iHEAL in Context: Effectiveness of a Health Promotion Intervention for Women Who Have Experienced Intimate Partner Violence (iHEAL Trial)
- ClinicalTrials.gov ID
- NCT03573778
- Acronym / sponsor ID
- 111191
- Conditions
- Intimate Partner Violence
- Keywords
- health, quality of life, safety, health promotion, intimate partner violence, domestic violence, confidence, control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 331 participants (actual)
- Lead sponsor
- Western University, CanadaUniversity, hospital or other
- Collaborators
- University of British Columbia, University of New Brunswick, McMaster University, Johns Hopkins University, Université de Montréal, Public Health Agency of Canada (PHAC)
- Study start
- 26 Sep 2018 (actual)
- Primary completion
- 24 Apr 2020 (actual)
- Study completion
- 22 May 2021 (actual)
- First posted
- 29 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized Controlled trial comparing active treatment to usual care
| Arm | Type | Receives |
|---|---|---|
| iHEAL | Experimental | Behavioral: iHEAL10-18 visits (over 6 months) with a Registered Nurse |
| Usual Care | Active comparator | Behavioral: Information about Community ServicesInformation about Community Services |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iHEALWomen 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. | Behavioural | iHEAL |
| Information about Community ServicesWomen 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. | Behavioural | Usual Care |
Primary outcome
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.
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.
19 secondary outcomes
Changes in Quality of Life on the Quality of Life Scale (Sullivan)
Time frame: baseline, 12 months
Changes in Quality of Life on the Quality of Life Scale (Sullivan)
Time frame: Baseline, 18 months
Changes in PTSD Symptomology on the PTSD Checklist (Civilian Version)
Time frame: Baseline, 12 months
Changes in PTSD Symptomology on the PTSD Checklist (Civilian Version)
Time frame: Baseline, 18 months
Changes in Depressive Symptoms on the Center for Epidemiologic Studies Depression Scale, Revised (CESD-R).
Time frame: Baseline, 6 months
Changes in Depressive Symptoms on the Center for Epidemiologic Studies Depression Scale, Revised
Time frame: Baseline, 12 months
Changes in Depressive Symptoms on the Center for Epidemiologic Studies Depression Scale, Revised
Time frame: Baseline, 18 months
Changes in Chronic Pain Disability on the Chronic Pain Grade (van Korff)
Time frame: Baseline, 6 months
Changes in Chronic Pain Disability on the Chronic Pain Grade (van Korff)
Time frame: Baseline, 12 months
Changes in Chronic Pain Disability on the Chronic Pain Grade (van Korff)
Time frame: Baseline, 18 months
Changes in Personal Control on the Personal Agency Scale (Smith)
Time frame: Baseline, 6 months
Changes in Personal Control on the Personal Agency Scale (Smith)
Time frame: Baseline, 12 months
Changes in Personal Control on the Personal Agency Scale (Smith)
Time frame: Baseline, 18 months
Changes in Confidence (self-efficacy) on investigator-developed scale
Time frame: Baseline, 6 months
Changes in Confidence (self-efficacy) on investigator-developed scale
Time frame: Baseline, 12 months
Changes in Confidence (self-efficacy) on investigator-developed scale
Time frame: Baseline, 18 months
Changes in Coercive Control on the Women's Experiences of Battering Scale (WEB)
Time frame: Baseline, 6 months
Changes in Coercive Control on the Women's Experiences of Battering Scale (WEB)
Time frame: Baseline, 12 months
Changes in Coercive Control on the Women's Experiences of Battering Scale (WEB)
Time frame: Baseline, 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2024.
- Derived from this study: PubMed 38326832Ford-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marilyn Ford-Gilboe, PhD principal investigator
Western University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iHEAL and Information about Community Services in people with Intimate Partner Violence, run by Western University, Canada at 3 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Quality of Life on the Quality of Life Scale (Sullivan) (time frame: baseline, 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03573778, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2024.