Using Smartphones in the Neonatal Intensive Care Unit

Self-efficacy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01987180
• Other study ID #: NICU2Home Feasability
• Status: Completed
• Phase: N/A
• First received: October 31, 2013
• Last updated: October 5, 2015
• Start date: January 2013
• Est. completion date: June 2015

Study information

• Verified date: October 2015
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Agency for Healthcare Research and Quality
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: June 2015
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Self-efficacy

Locations

Country	Name	City	State
United States	Prentice Women's Hospital	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Questionnaires to measure change from baseline in parents' distress and depression	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)	2 weeks before discharge (baseline) and 2 weeks after discharge	No