Clinical trial NCT01987180: Using Smartphones in the Neonatal Intensive Care Unit
Official title: NICU-2-HOME: Using HIT to Support Parents of NICU Graduates Transitioning Home
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Self-efficacy
Keywords: self-efficacy
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2013-11-19
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Parents of Very Low Birth Weight infants preparing for transition to home

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.

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

Primary outcomes:
measure: saliva collection
timeFrame: 2 weeks before discharge and 2 weeks after discharge
Secondary outcomes:
measure: Questionnaires to measure change from baseline in parents' distress and depression
timeFrame: 2 weeks before discharge (baseline) and 2 weeks after discharge
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Prentice Women's Hospital
state: Illinois
Study officials:
affiliation: Northwestern University Feinberg School of Medicine
name: Craig Garfield, MD
role: PRINCIPAL_INVESTIGATOR
References: