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Domestic ViolenceNCT01688427

Perinatal Nurse Home Visiting Enhanced With mHealth Technology

A study testing Standard IPV Assessment and Standard DOVE Intervention in people with Domestic Violence and Intimate Partner Violence, run by Johns Hopkins University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This research is being done to test whether mobile technology will reduce possible communication barriers between women and their home visitor; to improve assessing for health problems that could affect their pregnancy; to help in the delivery of information and actions to improve the health of the woman and their… Read more about this study

Who is it for?
Ages 15 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for
Domestic Violence, Intimate Partner Violence
What is being tested?
Standard IPV Assessment and Standard DOVE Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
433 participants
Where
1 siteUnited States
Study dates
Oct 2012to 30 Sep 2018
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 15 to 45 years
  • Women only
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • Pregnant women in Baltimore, Virginia, and Missouri if needed.
  • Speak English or Spanish
  • Eligible for home visitation.

Who cannot join

  • Women who begin participation in a perinatal home visiting program after the baby is born.
  • Women who do not speak English or Spanish.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Johns Hopkins University, School of Nursing

    Baltimore, Maryland, 21205

Other trials in United States

About this study

This research is being done to test whether mobile technology will reduce possible communication barriers between women and their home visitor; to improve assessing for health problems that could affect their pregnancy; to help in the delivery of information and actions to improve the health of the woman and their child.

Read the detailed description

This study addresses PA-11-104 calling for Reducing Health Disparities among Minority and Underserved Children. The Institute of Medicine, World Health Organization and Centers for Disease Control and Prevention recognize that prenatal home visitation, which improves the well-being of mother and children, presents an opportunity to provide early intervention to reduce intimate partner violence (IPV) and the impact the exposure has on the children. Major challenges for nurses and other home visitors (HV) are to accurately identify abused women and facilitate their accessing resources needed to change their situation. HVs often find it difficult to assess and intervene for IPV in the intimacy of home settings. The use of mHealth technology may increase the sensitivity of screening instruments and reduce communication barriers between HVs and clients regarding IPV, as well as enhance implementation of IPV interventions and allow for a more standard delivery of an intervention. Building on the successful trial testing the DOVE IPV intervention in prenatal home visiting programs (NR009093), the investigators propose to test mHealth technology using an open-source application, eMOCHA, to improve assessment of IPV and to deliver the DOVE intervention. The proposed eMOCHA DOVE study will first (Specific Aim/Phase 1) compare sensitivity and specificity of two different approaches for IPV assessment; paper and pencil versus the eMOCHA mHealth technology. Phase 2 (Aim 2) will compare effectiveness of the DOVE intervention delivered in standard form (paper brochure) versus mHealth eMOCHA DOVE application. In Phase 1 women enrolled in a perinatal home visiting program and consenting to the study, will be randomized to one of the two assessment groups and assessed for IPV at enrollment, birth and 2 months post birth. Women who are IPV positive (IPV+) at any of the assessment times will be re-randomized to receive the DOVE intervention by one of the two approaches. 1600 Medicaid eligible pregnant women in a perinatal home visiting program (800 from urban Baltimore and 800 from rural Virginia) will be recruited for Phase I and 400 IPV+ women (200 from each site) for Phase II. Women participating in Phase 2 will receive 6 home visit interventions over 6 months. Maternal outcomes related to IPV and mental health and selected infant outcomes will be collected at enrollment, 3, 6, 12, and 18 months after entry into Phase 2. Specific Aim 1 will use logistic and linear regression models to examine the proportion of women experiencing IPV through mHealth technology versus paper and pencil on the same validated assessments. Specific Aim 2 (comparing effectiveness of two intervention administrations) will be assessed with logistic and linear regression models for categorical (proportion abused and premature infants) and continuous outcome variables (e.g. depression, frequency and severity of physical, psychological, sexual IPV, use of community resources) respectively. Study findings will assist nurse home visitation programs to use best approaches for routine assessment of IPV and implement empowerment interventions to reduce IPV and improve maternal infant health outcomes.

Being tested
Standard IPV Assessment, Standard DOVE Intervention

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Standard IPV AssessmentBehavioural

    Test the effectiveness of the eMOCHA DOVE application using mHealth technology for routine assessment of IPV vs. Pencil and paper at enrollment, delivery, and 2 months post birth.

  • Standard DOVE InterventionBehavioural

    Intervention will be administered via eMOCHA tablet vs. home visitor over 6 sessions in 6 months.

Study groups in NCT01688427
Study groupRoleWhat they receive
Standard IPV AssessmentExperimentalTest the effectiveness of the eMOCHA DOVE application using mHealth technology for routine assessment of IPV vs. Pencil and paper.
Receives: Behavioral: Standard IPV Assessment
Standard DOVE interventionExperimentalThe standard DOVE intervention has already been developed and tested (NR009093). The standard DOVE intervention is a brochure based 10 minute intervention that the home visitor reviews with the women. It consists of information about IPV, its effects on pregnancy and infant health, community resources and a plan for individual safety options. For the eMOCHA DOVE intervention, the DOVE 10 minute brochure intervention will be converted from the paper format to a visually colorful interactive presentation loaded into the home visitor device using the eMOCHA application. The format will be completely activated and implemented by the women. She uses small ear buds and a touch screen, so how she responds and interacts with the media enhanced eMOCHA DOVE intervention is private.
Receives: Behavioral: Standard IPV Assessment; Behavioral: Standard DOVE Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in IPV assessments

    Instances of intimate partner violence (IPV).

    Measured: Screening and at 2 months post-birth.

Secondary outcomes (2)
  1. Change in use of safety behaviors

    Record the number of pregnant/parenting women using safety behaviors (including mental health and other community resources).

    Measured: Baseline and end of study (approximately 18 months post-birth)

  2. Change in number of safety behaviors

    Record the aggregate number of services (including mental health and other community resources).

    Measured: Baseline and end of study (approximately 18 months post-birth)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2012 (estimated)
  2. Study startOct 2012
  3. Primary completion30 Sep 2016
  4. Study completion30 Sep 2018

Resources

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
Single group
Masking
None (open label)
Enrolment
433 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01688427
Sponsor's protocol ID
NA_00051481
Other IDs
1R01HD071771-01
Status last verified
Mar 2019
First submitted
10 Sep 2012
Last updated
6 Mar 2019
Results posted
No
Data monitoring committee
Yes

Publications

  • Sharps P, Bullock L, Perrin N, Campbell J, Hill K, Kanu I, Norling M, Russell NG. Comparison of different methods of screening to identify intimate partner violence: A randomized controlled trial. Public Health Nurs. 2024 Mar-Apr;41(2):328-337. doi: 10.1111/phn.13279. Epub 2024 Jan 24.

    PubMed 38265246
  • Bacchus LJ, Bullock L, Sharps P, Burnett C, Schminkey DL, Buller AM, Campbell J. Infusing Technology Into Perinatal Home Visitation in the United States for Women Experiencing Intimate Partner Violence: Exploring the Interpretive Flexibility of an mHealth Intervention. J Med Internet Res. 2016 Nov 17;18(11):e302. doi: 10.2196/jmir.6251.

    PubMed 27856405

Questions about this trial

What is this clinical trial studying?

A study testing Standard IPV Assessment and Standard DOVE Intervention in people with Domestic Violence and Intimate Partner Violence, run by Johns Hopkins University at 1 site in United States.

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 3 inclusion and 2 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 6 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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?

Change in IPV assessments (time frame: Screening and at 2 months post-birth.). 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 NCT01688427, which also lists 2 linked publications.

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 6 Mar 2019.

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