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Clinical Trials/NCT01987180
NCT01987180
Completed
N/A

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

Northwestern University1 site in 1 country90 target enrollmentJanuary 2013
ConditionsSelf-efficacy

Overview

Phase
N/A
Intervention
Not specified
Conditions
Self-efficacy
Sponsor
Northwestern University
Enrollment
90
Locations
1
Primary Endpoint
saliva collection
Status
Completed
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2013
End Date
June 2015
Last Updated
10 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Craig Garfield

Associate Professor

Northwestern University

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

  • Not provided

Outcomes

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

Study Sites (1)

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