Using Smartphones in the Neonatal Intensive Care Unit

NCT01987180 | Completed

• 1 other identifier: NICU2Home Feasability
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Self-efficacy

Keywords

self-efficacy

Outcome Measures

Primary Outcomes (1)

• saliva collection

  Parents will be asked to provide saliva samples at four different days (the day prior to discharge, the day after discharge, five days after discharge, and 2 weeks after discharge) at the following three times each day: when they wake up, 30 minutes later, and at bedtime.

  2 weeks before discharge and 2 weeks after discharge

Secondary Outcomes (1)

• Questionnaires to measure change from baseline in parents' distress and depression

  2 weeks before discharge (baseline) and 2 weeks after discharge

Study Arms (2)

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.

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Parents of Very Low Birth Weight infants preparing for transition to home

You may qualify if:

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

You may not qualify if:

• \- N/A

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Prentice Women's Hospital

Chicago, Illinois, 60611, United States

Location

Study Officials

• Craig Garfield, MD

  Northwestern University Feinberg School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 31, 2013
• First Posted: November 19, 2013
• Study Start: January 1, 2013
• Primary Completion: February 1, 2014
• Study Completion: June 1, 2015
• Last Updated: October 6, 2015

Record last verified: 2015-10

Locations

US (1)