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

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.

Study Overview

• Status: Completed
• Conditions: Patient Engagement; Parent-Child Relations; Parenting; Self Efficacy; Patient Empowerment; Premature Infant Disease; Family Research; Chronic Conditions, Multiple
• Intervention / Treatment: Behavioral: PREEMIE PROGRESS; Behavioral: Attention Control

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 Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ashley M Weber, PhD, RN, RNC-NIC; Phone Number: 513-558-0132; Email: ashley.weber@uc.edu

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45221
      • University of Cincinnati

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Receipt of mother's human milk	(exclusive, partial, none)	Category determined at 36 weeks corrected gestional age
Z score of weight gain at 36 weeks corrected gestational age	Z-score method	Caculated for the date that infant is 36 weeks corrected gestational age
NICU Length of Stay	Days of NICU hospitalization (calculated from days between date of birth to date of discharge from NICU)	Date of NICU discharge will be assessed until study completion, with maximum of 1 year
Self -Report of Hospital readmissions & ER visits	Raw count w/in 30 days of discharge (self-report by phone)	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
Parent Self-Rating of Depression	Patient-Reported Outcomes Measurement Information System (PROMIS) 8a Higher scores indicate higher levels of depression: T-score: standardized score mean of 50 and standard deviation (SD) of 10	2 weeks after baseline visit
Parent Self-Rating of Anxiety	Patient-Reported Outcomes Measurement Information System (PROMIS) 8a Higher scores indicate higher levels of anxiety: T-score: standardized score mean of 50 and standard deviation (SD) of 10	2 weeks after baseline visit

Collaborators and Investigators

• Sponsor: University of Cincinnati
• Collaborators: National Institute of Nursing Research (NINR)
• Investigators: Principal Investigator: Ashley M Weber, PhD, RN, RNC-NIC, University of Cincinnati

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2022
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: October 22, 2020
• First Submitted That Met QC Criteria: November 16, 2020
• First Posted (Actual): November 20, 2020

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 13, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: self-management; patient education; prematurity; neonatal intensive care unit; family management
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infant, Newborn, Diseases; Infant, Premature, Diseases; Chronic Disease; Multiple Chronic Conditions
• Other Study ID Numbers: 2019-0475; 1K23NR019081 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No