Using Smartphones in the Neonatal Intensive Care Unit

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.

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Key information

Conditions

Self-Efficacy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Prentice Women's Hospital

Chicago, Illinois, 60611, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

saliva collection

Time frame: 2 weeks before discharge and 2 weeks after discharge

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.

Secondary outcomes

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

Time frame: 2 weeks before discharge (baseline) and 2 weeks after discharge

Parents will be asked to complete a particular set of surveys depending on which study day they are on. The study days include: 2 weeks prior to discharge (baseline), the day prior to discharge, the day after discharge, five days after discharge, and 2 weeks after discharge. Parents will complete the surveys independently without consulting their partner.

The survey includes parenting sense of competence scale (PSOC), revised dyadic adjustment scale (RDAS), edinburgh postnatal depression scale (EPDS),perceived stress scale (PSS)

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Official study title

NICU-2-HOME: Using HIT to Support Parents of NICU Graduates Transitioning Home

Important dates

Study start: 2013
Primary completion: 2014
Study completion: 2015
First posted: Nov 19, 2013
Registry last updated: Oct 6, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed