Perinatal Nurse Home Visiting Enhanced With mHealth Technology

Domestic Violence Clinical Trial

Official title:

Perinatal Nurse Home Visiting Enhanced With mHealth Technology

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01688427
• Other study ID #: NA_00051481
• Secondary ID: 1R01HD071771-01
• Status: Completed
• Phase: N/A
• Start date: October 2012
• Est. completion date: September 30, 2018

Study information

• Verified date: March 2019
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 child.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 433
• Est. completion date: September 30, 2018
• Est. primary completion date: September 30, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years to 45 Years

Eligibility

Inclusion Criteria:

• Pregnant women in Baltimore, Virginia, and Missouri if needed.

• Speak English or Spanish

• Eligible for home visitation.

Exclusion Criteria:

• Women who begin participation in a perinatal home visiting program after the baby is born.

• Women who do not speak English or Spanish.

Related Conditions & MeSH terms

• Domestic Violence
• Intimate Partner Violence

Intervention

Behavioral:
• Standard IPV Assessment
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 Intervention
Intervention will be administered via eMOCHA tablet vs. home visitor over 6 sessions in 6 months.

Locations

Country	Name	City	State
United States	Johns Hopkins University, School of Nursing	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in IPV assessments	Instances of intimate partner violence (IPV).	Screening and at 2 months post-birth.
Secondary	Change in use of safety behaviors	Record the number of pregnant/parenting women using safety behaviors (including mental health and other community resources).	Baseline and end of study (approximately 18 months post-birth)
Secondary	Change in number of safety behaviors	Record the aggregate number of services (including mental health and other community resources).	Baseline and end of study (approximately 18 months post-birth)