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| ID | Type | Description | Link |
|---|---|---|---|
| 1K23NR019081 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Nursing Research (NINR) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PREEMIE PROGRESS | Experimental | 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. |
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| Attention Control | Active Comparator | To maintain their attention, control parents will view "Welcome Videos" that explain hand hygiene, visitor IDs, parking, etc. on their mobile devices. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PREEMIE PROGRESS | Behavioral | PREEMIE PROGRESS is a video-based training program for parents of preterm infants hospitalized in the neonatal intensive care unit (NICU). |
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| Measure | Description | Time Frame |
|---|---|---|
| Maternal 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 The T-score is a score on a scale where 50 represents the average for the US general population (minimum of 8a Short Form is 38.2, maximum is 81.3). Each 10-point change represents one standard deviation (SD). A T-score of 75 or greater indicates clinically significant, severe symptoms. | Assessed at Baseline14 days post-baseline (T2), 28 days post-baseline (T3), and 30 days after infant discharge from the NICU (T4). Change from Baseline to 30 days after infant discharge from the NICU (T4) Reported. |
| Maternal 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 The T-score is a score on a scale where 50 represents the average for the US general population (minimum of 8a Short Form is 38.2, maximum is 81.3). Each 10-point change represents one standard deviation (SD). A T-score of 75 or greater indicates clinically significant, severe symptoms. | Assessed at Baseline, 14 days post-baseline (T2), 28 days post-baseline (T3), and 30 days after infant discharge from the NICU (T4). Change from Baseline to 30 days after infant discharge from the NICU (T4) Reported. |
| Receipt of Exclusive Mother's Human Milk | Number of infants receiving exclusive mother's milk were recorded and percent of infants was calculated from the total number number of infants receiving enteral feeds. Infants were marked as receiving exclusive mother's milk if all feeds were mother's milk (i.e., infant did not receive donor milk or formula). Percent of infants receiving exclusive mother's milk = Number of infants receiving exclusive mother's milk / Number of infants on enteral feeds | Assessed at Baseline, 14 days post-baseline (T2), 28 days post-baseline (T3). |
| Change in Fenton 2013 Growth Calculator Z-scores From Birth to 36 Weeks Corrected Gestational Age |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ashley M Weber, PhD, RN, RNC-NIC | University of Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Cincinnati | Cincinnati | Ohio | 45221 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40397935 | Derived | Weber A, Bakas T, Oudat Q, Parikh NA, Lambert J, Tubbs-Cooley HL, Rice J, Voos K, Rota M, Kaplan HC. An Internet-Based and Mobile Family Management Intervention for Mothers of Very Preterm Infants Hospitalized in the Neonatal Intensive Care Unit (the Preemie Progress Program): Pilot Randomized Controlled Trial. JMIR Form Res. 2025 May 21;9:e66073. doi: 10.2196/66073. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. PREEMIE PROGRESS: PREEMIE PROGRESS is a video-based training program for parents of preterm infants hospitalized in the neonatal intensive care unit (NICU). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 22, 2020 |
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| Attention Control | Behavioral | usual care and welcome videos |
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Change in Z score weight from birth to 36 weeks corrected gestational age (or at discharge if earlier) was calculated using PediTools Fenton 2013 Growth Calculator for Preterm Infants. Z-scores are the number of standard deviations above or below a growth chart's center (mean) curve. A Fenton preterm growth chart Z-score of 0 means the infant's growth measurement (e.g., weight) is at the average (mean) for their age and sex. Changes in Z-scores tell if a second measurement is closer or further away from the growth chart center than the previous measurement. Change in Z-score of 0 means the infant's percentile on the growth chart did not change. Higher Z scores indicate increased growth acceleration. The Academy of Nutrition and Dietetics considers Z score changes less than -0.8 to indicate growth failure. Normal growth during NICU hospitalization is defined as a z-score change of -0.79 to 0.79. Z score Δ = [Zscore at 36 weeks corrected gestational age] - [Zscore at birth] |
| Z scores were calculated at 36 weeks corrected gestational age (or at discharge if earlier) and at birth. |
| 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 |
| Infant Hospital Readmissions and Emergency Department Visits Within 30 Days of Infant Discharge - YES Response | The infant's electronic health record was reviewed for hospital readmissions and emergency department visits within 30 days of infant discharge. Mothers were also asked "Did your infant have any re-hospitalizations or emergency department visits within 30 days of discharge?", to ensure all rehospitalizations and ED visits were captured. | Thirty days after infant discharge from the NICU. |
| FG001 | Attention Control | To maintain their attention, control parents will view "Welcome Videos" that explain hand hygiene, visitor IDs, parking, etc. on their mobile devices. Attention Control: usual care and welcome videos |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. PREEMIE PROGRESS: PREEMIE PROGRESS is a video-based training program for parents of preterm infants hospitalized in the neonatal intensive care unit (NICU). |
| BG001 | Attention Control | To maintain their attention, control parents will view "Welcome Videos" that explain hand hygiene, visitor IDs, parking, etc. on their mobile devices. Attention Control: usual care and welcome videos |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age of mothers (in years) | Mean | Standard Deviation | years |
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| Age, Customized | Mean | Standard Deviation | weeks |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Birth weight (g) | Mean | Standard Deviation | grams |
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| Income (in $10,000) | Mean | Standard Deviation | Annual income in $10,000 |
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| PROMIS (Patient-Reported Outcomes Measurement Information System)8a Anxiety | T-scores are reported. A PROMIS (Patient-Reported Outcomes Measurement Information System) T-score is a standardized score that helps compare an individual's score to the general population. The T-score is a score on a scale where 50 represents the average for the US general population. Each 10-point change represents one standard deviation (SD). A T-score of 75 or greater indicates clinically significant, severe symptoms. Higher T-scores indicate a higher level of the concept being measured. For example, a higher anxiety T-score would indicate more anxious symptoms. | Mean | Standard Deviation | T-score |
| ||||||||||||||
| PROMIS (Patient-Reported Outcomes Measurement Information System)8a Depression | T-scores are reported. A PROMIS (Patient-Reported Outcomes Measurement Information System) T-score is a standardized score that helps compare an individual's score to the general population. The T-score is a score on a scale where 50 represents the average for the US general population. Each 10-point change represents one standard deviation (SD). A T-score of 75 or greater indicates clinically significant, severe symptoms. Higher T-scores indicate a higher level of the concept being measured. For example, a higher depression T-score would indicate more depressive symptoms. | Mean | Standard Deviation | T-score |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Maternal 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 The T-score is a score on a scale where 50 represents the average for the US general population (minimum of 8a Short Form is 38.2, maximum is 81.3). Each 10-point change represents one standard deviation (SD). A T-score of 75 or greater indicates clinically significant, severe symptoms. | The percent of videos mothers watched were controlled in our analyses showing data trends as change scores. At each follow-up time point [14 days post-baseline (T2), 28 days post-baseline (T3), and 30 days after infant discharge from the NICU (T4)], we computed mean differences and 95% CI between groups to evaluate trends in outcomes. Reported here are mean (SE) in change scores from Baseline to 30 days after infant discharge from the NICU (T4). | Posted | Mean | Standard Error | T-score mean changes | Assessed at Baseline14 days post-baseline (T2), 28 days post-baseline (T3), and 30 days after infant discharge from the NICU (T4). Change from Baseline to 30 days after infant discharge from the NICU (T4) Reported. |
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| Primary | Maternal 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 The T-score is a score on a scale where 50 represents the average for the US general population (minimum of 8a Short Form is 38.2, maximum is 81.3). Each 10-point change represents one standard deviation (SD). A T-score of 75 or greater indicates clinically significant, severe symptoms. | The percent of videos mothers watched were controlled in our analyses showing data trends as change scores. At each follow-up time point [14 days post-baseline (T2), 28 days post-baseline (T3), and 30 days after infant discharge from the NICU (T4)], we computed mean differences and 95% CI between groups to evaluate trends in outcomes. Reported here are mean (SE) in change scores from Baseline at each time point in the study. | Posted | Mean | Standard Error | T-score | Assessed at Baseline, 14 days post-baseline (T2), 28 days post-baseline (T3), and 30 days after infant discharge from the NICU (T4). Change from Baseline to 30 days after infant discharge from the NICU (T4) Reported. |
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| Primary | Receipt of Exclusive Mother's Human Milk | Number of infants receiving exclusive mother's milk were recorded and percent of infants was calculated from the total number number of infants receiving enteral feeds. Infants were marked as receiving exclusive mother's milk if all feeds were mother's milk (i.e., infant did not receive donor milk or formula). Percent of infants receiving exclusive mother's milk = Number of infants receiving exclusive mother's milk / Number of infants on enteral feeds | Assessed at Baseline, 14 days post-baseline (T2), 28 days post-baseline (T3). | Posted | Count of Participants | Participants | Assessed at Baseline, 14 days post-baseline (T2), 28 days post-baseline (T3). |
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| Primary | Change in Fenton 2013 Growth Calculator Z-scores From Birth to 36 Weeks Corrected Gestational Age | Change in Z score weight from birth to 36 weeks corrected gestational age (or at discharge if earlier) was calculated using PediTools Fenton 2013 Growth Calculator for Preterm Infants. Z-scores are the number of standard deviations above or below a growth chart's center (mean) curve. A Fenton preterm growth chart Z-score of 0 means the infant's growth measurement (e.g., weight) is at the average (mean) for their age and sex. Changes in Z-scores tell if a second measurement is closer or further away from the growth chart center than the previous measurement. Change in Z-score of 0 means the infant's percentile on the growth chart did not change. Higher Z scores indicate increased growth acceleration. The Academy of Nutrition and Dietetics considers Z score changes less than -0.8 to indicate growth failure. Normal growth during NICU hospitalization is defined as a z-score change of -0.79 to 0.79. Z score Δ = [Zscore at 36 weeks corrected gestational age] - [Zscore at birth] | Z score Δ = [Zscore at 36 weeks corrected gestational age] - [Zscore at birth] | Posted | Median | Inter-Quartile Range | Z-score | Z scores were calculated at 36 weeks corrected gestational age (or at discharge if earlier) and at birth. |
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| Primary | NICU Length of Stay | Days of NICU hospitalization (calculated from days between date of birth to date of discharge from NICU) | Posted | Mean | Standard Deviation | days | Date of NICU discharge will be assessed until study completion, with maximum of 1 year |
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| Primary | Infant Hospital Readmissions and Emergency Department Visits Within 30 Days of Infant Discharge - YES Response | The infant's electronic health record was reviewed for hospital readmissions and emergency department visits within 30 days of infant discharge. Mothers were also asked "Did your infant have any re-hospitalizations or emergency department visits within 30 days of discharge?", to ensure all rehospitalizations and ED visits were captured. | Coded as Yes/No and extracted from the infant's electronic health record. Mothers were also asked "Did your infant have any re-hospitalizations or emergency department visits within 30 days of discharge?", to ensure all rehospitalizations and ED visits were captured. | Posted | Count of Participants | Participants | Thirty days after infant discharge from the NICU. |
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Assessed at Baseline, 14 days post-baseline (T2), 28 days post-baseline (T3), and 30 days after infant discharge from the NICU (T4).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Attention Control | To maintain their attention, control parents will view "Welcome Videos" that explain hand hygiene, visitor IDs, parking, etc. on their mobile devices. Attention Control: usual care and welcome videos | 0 | 31 | 0 | 31 | 3 | 31 |
| EG001 | 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. PREEMIE PROGRESS: PREEMIE PROGRESS is a video-based training program for parents of preterm infants hospitalized in the neonatal intensive care unit (NICU). | 1 | 34 | 0 | 34 | 0 | 34 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Psychological Distress, Clinical significant Anxiety or Depression | Psychiatric disorders | Clinicaltrials.gov | Systematic Assessment | self-reported psychological distress or clinically significant symptoms of anxiety or depression (i.e., T-Score >75.0 on PROMIS8a Anxiety or PROMIS8a Depression) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Principal Investigator: Ashley Weber, PhD, RN, RNC-NIC | University of Cincinnati | 513-5580132 | ashley.weber@uc.edu |
| Apr 15, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D010358 | Patient Participation |
| D000071069 | Multiple Chronic Conditions |
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| T4 - Baseline |
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| Attention Control |
To maintain their attention, control parents will view "Welcome Videos" that explain hand hygiene, visitor IDs, parking, etc. on their mobile devices. Attention Control: usual care and welcome videos |
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| Units | Counts |
|---|---|
| Participants |
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| OG001 | Attention Control | To maintain their attention, control parents will view "Welcome Videos" that explain hand hygiene, visitor IDs, parking, etc. on their mobile devices. Attention Control: usual care and welcome videos |
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