Using Smartphones in the Neonatal Intensive Care Unit

NCT ID: NCT01987180

Last Updated: 2015-10-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 90 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2015-06-30

Brief Summary

The goal of this research is to develop and pilot the NICU-2-Home service, a health information technology (IT) concept centered on a smart phone app. NICU-2-Home will provide support to parents of very low birth weight (VLBW) infants as they transition from the NICU to their homes and eventually establish a medical home with the infant's pediatrician. Once the app is developed, we will conduct a feasibility study with randomization to pilot test the ability of NICU-2-Home app to (a) improve parent's self-efficacy and confidence in caring for their VLBW infant, (b) decrease parental stress, and (c) enhance involvement with their VLBW infants compared to controls.

Detailed Description

After 2-3 months in the Neonatal Intensive Care Unit (NICU), mothers and fathers of Very Low Birth Weight (VLBW) infants face discharge home with trepidation. Having a VLBW infant that has survived to discharge, these parents now must perform a myriad of health care tasks once at home, yet parents often feel ill-prepared, uninformed, and unskilled to provide this care. The goal of this exploratory research is to develop and pilot the NICU-2-Home service, a health information technology (IT) concept centered on the smart phone that will be created with researchers at Motorola. NICU-2-Home will provide support to parents of VLBW infants as they transition from the NICU to their homes and eventually establish a medical home with the infant's pediatrician. Phase 1 of this research uses qualitative methods and an iterative process to design the NICU-2-Home content service that will support parents as they transition to home from the NICU through interviews with the major stakeholders: parents, neonatal physicians, neonatal staff, and community pediatricians. Phase 2 evaluates NICU-2-Home as parents are transitioning to home and includes a feasibility study with randomization to pilot test the ability of NICU-2-Home to (a) improve parent's self-efficacy and confidence in caring for their VLBW infant, (b) decrease parental stress, and (c) enhance involvement with their VLBW infants compared to controls.

Conditions

Self-efficacy

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Usual standard care

Parents will be provided with the usual standard of care in the NICU. Discharge information will be provided to parents as is typically done in the NICU for VLBW infants getting ready to go home. Typical handouts are given to parents that describe their child's care and needs specifically as well as general guidelines. The project coordinator for the research study will verify that parents received information prior to discharge from the NICU staff. Parents will determine how you use this information.

No interventions assigned to this group

NICU-2-Home mobile app user

Parents will receive smartphone and unique NICU-2-Home app for their use. A pair of parents will be given two smartphones and will be asked to use the devices in their preferred way. Within the given app there is a baby tracking tool (baby-connect.com) that enables parents to keep track of the baby's feeding, diapers, sleep, health, medicines, vaccines, photos, etc. The objective in doing this is not to monitor the growth and development of the child; rather, it is to observe what tools within the app parents use and how frequently they use them.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• English-speaking
• Older than 18 years old
• Have at least one VLBW infant who survived to discharge and transitioned to home

Exclusion Criteria

• N/A

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Craig Garfield

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Craig Garfield, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University Feinberg School of Medicine

Locations

Prentice Women's Hospital

Chicago, Illinois, United States

Countries

United States

Other Identifiers

NICU2Home Feasability

Identifier Type: -

Identifier Source: org_study_id