- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01987180
Using Smartphones in the Neonatal Intensive Care Unit
NICU-2-HOME: Using HIT to Support Parents of NICU Graduates Transitioning Home
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Illinois
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Chicago, Illinois, United States, 60611
- Prentice Women's Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
saliva collection
Time Frame: 2 weeks before discharge and 2 weeks after discharge
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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
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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) |
2 weeks before discharge (baseline) and 2 weeks after discharge
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Craig Garfield, MD, Northwestern University Feinberg School of Medicine
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- NICU2Home Feasability
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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