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

Primary Purpose

Premature Infant Disease, Family Research, Parent-Child Relations

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PREEMIE PROGRESS
Attention Control
Sponsored by
University of Cincinnati
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Premature Infant Disease focused on measuring neonatal intensive care unit, prematurity, family management, self-management, patient education

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of CincinnatiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PREEMIE PROGRESS

Attention Control

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Parent Self-Rating of Depression
Patient-Reported Outcomes Measurement Information System (PROMIS) 8a Higher scores indicate higher levels of depression: Scored 0-32.
Parent Self-Rating of Anxiety
Patient-Reported Outcomes Measurement Information System (PROMIS) 8a Higher scores indicate higher levels of anxiety: Scored 0-32.
Receipt of mother's human milk
(exclusive, partial, none)
Z score of weight gain at 36 weeks corrected gestational age
Z-score method
NICU Length of Stay
Days of NICU hospitalization (calculated from days between date of birth to date of discharge from NICU)
Self -Report of Hospital readmissions & ER visits
Raw count w/in 30 days of discharge (self-report by phone)

Secondary Outcome Measures

Full Information

First Posted
October 22, 2020
Last Updated
May 8, 2023
Sponsor
University of Cincinnati
Collaborators
National Institute of Nursing Research (NINR)
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1. Study Identification

Unique Protocol Identification Number
NCT04638127
Brief Title
PREEMIE PROGRESS: A Family Management Program for Parents of Preterm Infants
Official Title
PREEMIE PROGRESS: A Family Management Program for Parents of Preterm Infants
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 17, 2022 (Actual)
Primary Completion Date
October 3, 2023 (Anticipated)
Study Completion Date
December 25, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cincinnati
Collaborators
National Institute of Nursing Research (NINR)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Infant Disease, Family Research, Parent-Child Relations, Self Efficacy, Patient Engagement, Patient Empowerment, Parenting, Chronic Conditions, Multiple
Keywords
neonatal intensive care unit, prematurity, family management, self-management, patient education

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
74 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PREEMIE PROGRESS
Arm Type
Experimental
Arm Description
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.
Arm Title
Attention Control
Arm Type
Active Comparator
Arm Description
To maintain their attention, control parents will view "Welcome Videos" that explain hand hygiene, visitor IDs, parking, etc. on their mobile devices.
Intervention Type
Behavioral
Intervention Name(s)
PREEMIE PROGRESS
Intervention Description
PREEMIE PROGRESS is a video-based training program for parents of preterm infants hospitalized in the neonatal intensive care unit (NICU).
Intervention Type
Behavioral
Intervention Name(s)
Attention Control
Intervention Description
usual care and welcome videos
Primary Outcome Measure Information:
Title
Parent Self-Rating of Depression
Description
Patient-Reported Outcomes Measurement Information System (PROMIS) 8a Higher scores indicate higher levels of depression: Scored 0-32.
Time Frame
2 weeks after baseline visit
Title
Parent Self-Rating of Anxiety
Description
Patient-Reported Outcomes Measurement Information System (PROMIS) 8a Higher scores indicate higher levels of anxiety: Scored 0-32.
Time Frame
2 weeks after baseline visit
Title
Receipt of mother's human milk
Description
(exclusive, partial, none)
Time Frame
Category determined at 36 weeks corrected gestional age
Title
Z score of weight gain at 36 weeks corrected gestational age
Description
Z-score method
Time Frame
Caculated for the date that infant is 36 weeks corrected gestational age
Title
NICU Length of Stay
Description
Days of NICU hospitalization (calculated from days between date of birth to date of discharge from NICU)
Time Frame
Date of NICU discharge will be assessed until study completion, with maximum of 1 year
Title
Self -Report of Hospital readmissions & ER visits
Description
Raw count w/in 30 days of discharge (self-report by phone)
Time Frame
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ashley M Weber, PhD, RN, RNC-NIC
Phone
513-558-0132
Email
ashley.weber@uc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ashley M Weber, PhD, RN, RNC-NIC
Organizational Affiliation
University of Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45221
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ashley M Weber, PhD, RN, RNC-NIC
Phone
5135580132
Email
ashley.weber@uc.edu

12. IPD Sharing Statement

Learn more about this trial

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

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