Self-efficacyNCT01987180
Using Smartphones in the Neonatal Intensive Care Unit
An observational study of Self-efficacy, run by Northwestern University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Self-efficacy
- Type of treatment
- Vaccines
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Jun 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Parents of Very Low Birth Weight infants preparing for transition to home
Who may be able to join
- English-speaking
- Older than 18 years old
- Have at least one VLBW infant who survived to discharge and transitioned to home
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
About this study
Official title: NICU-2-HOME: Using HIT to Support Parents of NICU Graduates Transitioning Home
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.
Read the 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.
- Conditions
- Self-efficacy
- Keywords
- self-efficacy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 weeks before discharge and 2 weeks after discharge
Secondary outcomes (1)
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)
Measured: 2 weeks before discharge (baseline) and 2 weeks after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2013 (estimated)
- Study startJan 2013
- Primary completionFeb 2014
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Self-efficacyStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Craig Garfield, Northwestern University
- Investigators
- Craig Garfield, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01987180
- Sponsor's protocol ID
- NICU2Home Feasability
- Status last verified
- Oct 2015
- First submitted
- 31 Oct 2013
- Last updated
- 6 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NICU-2-HOME: Using HIT to Support Parents of NICU Graduates Transitioning Home
- ClinicalTrials.gov ID
- NCT01987180
- Acronym / sponsor ID
- NICU2Home Feasability
- Conditions
- Self-efficacy
- Keywords
- self-efficacy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 19 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Parents of Very Low Birth Weight infants preparing for transition to home
Key inclusion criteria (3 listed)
- English-speaking
- Older than 18 years old
- Have at least one VLBW infant who survived to discharge and transitioned to home
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Questionnaires to measure change from baseline in parents' distress and depression
Time frame: 2 weeks before discharge (baseline) and 2 weeks after discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2015.
Related trials for Self-efficacy
Active, not recruiting
Improving Student Mental Health Through a Universal Trauma-Informed Intervention
Anxiety Symptoms, Post-traumatic Stress Symptoms
Not yet recruitingPhase 2
Inhibition of Aggressive Behavior in Participants With Fragile X Syndrome
Aggressive Behavior in Fragile X Syndome
Recruiting
Dual Tasking Training to Enhance Self-Efficacy in Individuals With Parkinson's Disease
Parkinson´s Disease
Active, not recruiting
Online Written Imagery Rescripting for Shame and Negative Self-Cognitions in Malaysian Adults With Childhood Emotional Neglect
Shame, Childhood Emotional Neglect
Active, not recruiting
Improving Emotional Wellbeing of University Students: Emotion Regulation
Emotion Regulation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Craig Garfield, MD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Self-efficacy, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
saliva collection (time frame: 2 weeks before discharge and 2 weeks after discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2015.