NCT01688427

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
433

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 10, 2012

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 19, 2012

Completed
12 days until next milestone

Study Start

First participant enrolled

October 1, 2012

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2016

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2018

Completed
Last Updated

March 6, 2019

Status Verified

March 1, 2019

Enrollment Period

4 years

First QC Date

September 10, 2012

Last Update Submit

March 5, 2019

Conditions

Domestic ViolenceIntimate Partner Violence

Outcome Measures

Primary Outcomes (1)

  • Change in IPV assessments

    Instances of intimate partner violence (IPV).

    Screening and at 2 months post-birth.

Secondary Outcomes (2)

  • Change in use of safety behaviors

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

  • Change in number of safety behaviors

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

Study Arms (2)

Standard IPV Assessment

EXPERIMENTAL

Test the effectiveness of the eMOCHA DOVE application using mHealth technology for routine assessment of IPV vs. Pencil and paper.

Behavioral: Standard IPV Assessment

Standard DOVE intervention

EXPERIMENTAL

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 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.

Behavioral: Standard IPV AssessmentBehavioral: Standard DOVE Intervention

Interventions

Standard IPV AssessmentBEHAVIORAL

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 interventionStandard IPV Assessment
Standard DOVE InterventionBEHAVIORAL

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

Standard DOVE intervention

Eligibility Criteria

Age15 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins University, School of Nursing

Baltimore, Maryland, 21205, United States

Location

Related Publications (1)

  • 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.

    PMID: 27856405DERIVED

Study Officials

  • Phyllis W Sharps, PhD

    Johns Hopkins University, School of Nursing

    PRINCIPAL INVESTIGATOR

  • Linda Bullock, PhD, RN

    University of Virginia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 10, 2012

First Posted

September 19, 2012

Study Start

October 1, 2012

Primary Completion

September 30, 2016

Study Completion

September 30, 2018

Last Updated

March 6, 2019

Record last verified: 2019-03

Locations

US(1)