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Using Smartphones in the Neonatal Intensive Care Unit

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ClinicalTrials.gov Identifier: NCT01987180
Recruitment Status : Completed
First Posted : November 19, 2013
Last Update Posted : October 6, 2015
Sponsor:
Information provided by (Responsible Party):
Craig Garfield, Northwestern University

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.

Condition or disease
Self-efficacy

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.

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Study Type : Observational
Actual Enrollment : 90 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: NICU-2-HOME: Using HIT to Support Parents of NICU Graduates Transitioning Home
Study Start Date : January 2013
Actual Primary Completion Date : February 2014
Actual Study Completion Date : June 2015

Group/Cohort
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.



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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)




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Parents of Very Low Birth Weight infants preparing for transition to home
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01987180


Locations
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United States, Illinois
Prentice Women's Hospital
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Investigators
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Principal Investigator: Craig Garfield, MD Northwestern University Feinberg School of Medicine
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Responsible Party: Craig Garfield, Associate Professor, Northwestern University
ClinicalTrials.gov Identifier: NCT01987180    
Other Study ID Numbers: NICU2Home Feasability
First Posted: November 19, 2013    Key Record Dates
Last Update Posted: October 6, 2015
Last Verified: October 2015
Keywords provided by Craig Garfield, Northwestern University:
self-efficacy