Perinatal Nurse Home Visiting Enhanced With mHealth Technology

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2012 by Johns Hopkins University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Phyllis Sharps, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01688427
First received: September 10, 2012
Last updated: September 5, 2013
Last verified: September 2012
  Purpose

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.


Condition Intervention Phase
Domestic Violence
Behavioral: Standard IPV Assessment
Behavioral: Standard DOVE Intervention
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Perinatal Nurse Home Visiting Enhanced With mHealth Technology

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Change in IPV assessments [ Time Frame: Change in number from assessment of identificaion of intimate partner violence among pregnant women at screening and at 2 months post-birth. ] [ Designated as safety issue: Yes ]
    mHealth technology will be used to increase identification of IPV.


Secondary Outcome Measures:
  • Change in use of safety planning [ Time Frame: Increase in number of pregnant women using safety planning at baseline and at 18 months post-birth. ] [ Designated as safety issue: Yes ]
    Measurements will be used to assess use of safety planning, mental health, use of community resources.


Estimated Enrollment: 800
Study Start Date: October 2012
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Standard IPV Assessment
Test the effectiveness of the eMOCHA DOVE application using mHealth technology for routine assessment of IPV vs. Pencil and paper.
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.
Experimental: Standard DOVE intervention
The 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 interventon, the DOVE 10 minute brochure intervention will be converted from the paper format to a vusually colorful interactive presentaiton loaded into the home visitor device using the eMOCHA application. The format will be completely activiated 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.
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.
Behavioral: Standard DOVE Intervention
Intervention will be administered via eMOCHA tablet vs. home visitor over 6 sessions in 6 months.

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), we 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.

  Eligibility

Ages Eligible for Study:   15 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Pregnant women in Baltimore, Virginia, and Missouri if needed. Speak English or Spanish and are 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01688427

Contacts
Contact: Phyllis W Sharps, PhD 410-614-5312 psharps1@jhu.edu
Contact: Linda C Bullock, PhD 434-982-1966 lcb2u@virginia.edu

Locations
United States, Maryland
Johns Hopkins University, School of Nursing Recruiting
Baltimore, Maryland, United States, 21205
Contact: Phyllils W Sharps, PhD    410-614-5312    psharps1@jhu.edu   
Principal Investigator: Phyllis W Sharps, PhD, RN         
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Phyllis W Sharps, PhD Johns Hopkins University, School of Nursing
Principal Investigator: Linda Bullock, PhD, RN University of Virginia
  More Information

No publications provided

Responsible Party: Phyllis Sharps, Phyllis W. Sharps, PhD, RN, FAAN, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01688427     History of Changes
Other Study ID Numbers: 1RO1HD07177101, 1R01HD071771-01
Study First Received: September 10, 2012
Last Updated: September 5, 2013
Health Authority: United States: Federal Government

ClinicalTrials.gov processed this record on September 18, 2014