PREEMIE PROGRESS: A Family Management Program for Parents of Preterm Infants

Sponsor

University of Cincinnati (Other)

Overall Status

Recruiting

CT.gov ID

NCT04638127

Collaborator

National Institute of Nursing Research (NINR) (NIH)

Enrollment

Location

Arms

16.3

Anticipated Duration (Months)

4.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to refine and pilot test a mobile health (mHealth), video-based family management program for parents of preterm infants hospitalized in the Neonatal Intensive Care Unit (NICU). By moving beyond the basic infant care tasks taught by parenting programs and instead comprehensively training parents to use evidence-based family management skills, we hypothesize that our intervention, called PREEMIE PROGRESS, will better equip parents to meet the chronic, complex healthcare needs of their preterm infant.

Condition or Disease	Intervention/Treatment	Phase
Premature Infant Disease Family Research Parent-Child Relations Self Efficacy Patient Engagement Patient Empowerment Parenting Chronic Conditions, Multiple	Behavioral: PREEMIE PROGRESS Behavioral: Attention Control	N/A

Detailed Description

Increasing numbers of very preterm infants are surviving and have chronic, complex healthcare needs due to prematurity. These infants experience increased healthcare utilization, long durations of stay in the Neonatal Intensive Care Unit (NICU), and are at high risk of developing prematurity-related complications. As a result, their care is complex, and families need structured training to effectively understand, monitor, and manage their infant's care. PREEMIE PROGRESS is an innovative, video-based intervention that applies evidence-based family management theories to better equip parents to meet the chronic, complex healthcare needs of their preterm infant. This research aims to 1) refine a novel family management program, called PREEMIE PROGRESS, through iterative usability and acceptability testing and 2) test feasibility and acceptability of the refined intervention and study procedures in a pilot randomized controlled trial. This project will use implementation science tools and approaches to refine the intervention and study procedures to ensure that PREEMIE PROGRESS addresses key program elements that will be important for future adoption and implementation in NICU settings. We anticipate that the intervention will decrease parent anxiety and depression, increase infant weight gain and receipt of mother's milk, and reduce neonatal healthcare utilization. The long-term goal of this project is to develop, test, and translate into NICU practice an efficacious family management intervention for parents of preterm infants. Dr. Weber will significantly advance nursing science through this project by obtaining preliminary feasibility and acceptability data for a scalable and sustainable intervention to facilitate family management and improve parent-infant health outcomes.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

74 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

PREEMIE PROGRESS: A Family Management Program for Parents of Preterm Infants

Actual Study Start Date :

May 17, 2022

Anticipated Primary Completion Date :

Apr 3, 2023

Anticipated Study Completion Date :

Sep 25, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PREEMIE PROGRESS PREEMIE PROGRESS is an innovative, video-based intervention that applies evidence-based family management theories to better equip parents to meet the chronic, complex healthcare needs of their preterm infant.	Behavioral: PREEMIE PROGRESS PREEMIE PROGRESS is a video-based training program for parents of preterm infants hospitalized in the neonatal intensive care unit (NICU).
Active Comparator: Attention Control To maintain their attention, control parents will view "Welcome Videos" that explain hand hygiene, visitor IDs, parking, etc. on their mobile devices.	Behavioral: Attention Control usual care and welcome videos

Arm

Intervention/Treatment

Experimental: PREEMIE PROGRESS

PREEMIE PROGRESS is an innovative, video-based intervention that applies evidence-based family management theories to better equip parents to meet the chronic, complex healthcare needs of their preterm infant.

Behavioral: PREEMIE PROGRESS

PREEMIE PROGRESS is a video-based training program for parents of preterm infants hospitalized in the neonatal intensive care unit (NICU).

Active Comparator: Attention Control

To maintain their attention, control parents will view "Welcome Videos" that explain hand hygiene, visitor IDs, parking, etc. on their mobile devices.

Behavioral: Attention Control

usual care and welcome videos

Outcome Measures

Primary Outcome Measures

Parent Self-Rating of Depression [2 weeks after baseline visit]
Patient-Reported Outcomes Measurement Information System (PROMIS) 8a Higher scores indicate higher levels of depression: Scored 0-32.
Parent Self-Rating of Anxiety [2 weeks after baseline visit]
Patient-Reported Outcomes Measurement Information System (PROMIS) 8a Higher scores indicate higher levels of anxiety: Scored 0-32.
Receipt of mother's human milk [Category determined at 36 weeks corrected gestional age]
(exclusive, partial, none)
Z score of weight gain at 36 weeks corrected gestational age [Caculated for the date that infant is 36 weeks corrected gestational age]
Z-score method
NICU Length of Stay [Date of NICU discharge will be assessed until study completion, with maximum of 1 year]
Days of NICU hospitalization (calculated from days between date of birth to date of discharge from NICU)
Self -Report of Hospital readmissions & ER visits [Readmisssions/ER visits counted within 30 days of discharge will be assessed date of NICU discharge will be assessed until study completion, with maximum of 1 year]
Raw count w/in 30 days of discharge (self-report by phone)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

English-speaking parents
Parents preterm infants born 25 0/7-31 6/7 weeks gestational age (GA)
Parents who had a singleton or twin birth
Parents 18 years of age or older

Exclusion Criteria:

Mothers too ill (serious maternal complications, medications that impact alertness/ orientation) to provide informed consent
Infants with imminent or probable death based on the healthcare team's judgement