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Preemie Prep For Parents (P3): Home Antenatal Prematurity Education

Primary Purpose

Premature Birth, Decision Making, Prenatal Care

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Preemie Prep for Parents (P3) Outpatient Mobile Intervention
ACOG links
Sponsored by
Medical College of Wisconsin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Premature Birth focused on measuring gestational age, multi-media, mobile application, anxiety, clinical trial, random allocation

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Pregnant woman or her partner
  • At risk for preterm birth, as indicated by: history of spontaneous preterm birth (during the 34th week or earlier), shortened cervical length, multiple gestation, fetal growth restriction, chronic hypertension, history of preeclampsia, and/or diabetes requiring medications.
  • Gestational age of 16-21 weeks at recruitment.
  • Owns a smartphone.
  • Able to speak English

Exclusion Criteria:

• Pregnancies with known significant birth defects.

Sites / Locations

  • Froedtert Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Preemie Prep for Parents (P3) Outpatient Mobile Intervention

ACOG links

Arm Description

The P3 mobile intervention in its current form sends participants text messages according to a schedule based on their gestational age. These text messages contain links to short videos uploaded to the P3 site, focusing on topics related to preterm labor and premature infants.

Participants in the active control condition will receive links to patient education handouts about preterm birth provided by the American College of Obstetricians and Gynecologists.

Outcomes

Primary Outcome Measures

Prematurity Knowledge
Knowledge questionnaire developed by research team and tested through cognitive interviews, testing NICHD-recommended parental prematurity knowledge.
Prematurity Knowledge
Knowledge questionnaire developed by research team and tested through cognitive interviews, testing NICHD-recommended parental prematurity knowledge.
Prematurity Knowledge
Knowledge questionnaire developed by research team and tested through cognitive interviews, testing NICHD-recommended parental prematurity knowledge.
Parental preparation for decision-making
Preparation for Decision Making Scale (Graham, O'Connor 1996, revised 2005). Scale ranges from a score of 10 to 50, with 50 demonstrating maximum preparedness to make a decision.
Parental preparation for decision-making
Preparation for Decision Making Scale (Graham, O'Connor 1996, revised 2005). Scale ranges from a score of 10 to 50, with 50 demonstrating maximum preparedness to make a decision.
Parental preparation for decision-making
Preparation for Decision Making Scale (Graham, O'Connor 1996, revised 2005). Scale ranges from a score of 10 to 50, with 50 demonstrating maximum preparedness to make a decision.

Secondary Outcome Measures

Decision Self-Efficacy
Decision Self-Efficacy Scale (O'Connor, 1995). Scale ranges from a score of 0 to 44. A score of 44 would represent maximum decision self-efficacy.
Anxiety
PROMIS Anxiety Computerized Adaptive Test (CAT). As a Computer Adaptive Test (CAT), not all participants receive the same number of questions, but may range between 4 and 12 questions. The number and selection of questions is dependent on the previous responses. An average US adult has a score of 50 with a standard deviation of 10; the higher that t-score, the greater amount of anxiety the respondent is reporting.
Anxiety
PROMIS Anxiety Computerized Adaptive Test (CAT). As a Computer Adaptive Test (CAT), not all participants receive the same number of questions, but may range between 4 and 12 questions. The number and selection of questions is dependent on the previous responses. An average US adult has a score of 50 with a standard deviation of 10; the higher that t-score, the greater amount of anxiety the respondent is reporting.
Anxiety
PROMIS Anxiety Computerized Adaptive Test (CAT). As a Computer Adaptive Test (CAT), not all participants receive the same number of questions, but may range between 4 and 12 questions. The number and selection of questions is dependent on the previous responses. An average US adult has a score of 50 with a standard deviation of 10; the higher that t-score, the greater amount of anxiety the respondent is reporting.

Full Information

First Posted
September 13, 2019
Last Updated
April 18, 2022
Sponsor
Medical College of Wisconsin
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1. Study Identification

Unique Protocol Identification Number
NCT04093492
Brief Title
Preemie Prep For Parents (P3): Home Antenatal Prematurity Education
Official Title
Preemie Prep For Parents (P3) Outpatient Mobile Intervention: Home Antenatal Prematurity Education
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
February 3, 2020 (Actual)
Primary Completion Date
September 1, 2021 (Actual)
Study Completion Date
January 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical College of Wisconsin

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 Preemie Prep for Parents (P3) mobile intervention will be tested in an outpatient population of pregnant women at risk of preterm birth and their partners. The study is an RCT comparing knowledge and preparedness for decision making between a group receiving the P3 texts and videos and a group receiving links to ACOG prematurity patient education handouts.
Detailed Description
This is a randomized controlled study focused on an outpatient population of pregnant women at risk of preterm birth and their partners. The objective is to test the efficacy of the Preemie Prep for Parents (P3) intervention on prematurity knowledge and preparedness for decision making. Participants are recruited from their obstetric clinic appointment between weeks 16 and 21, and randomized 1:1 to either the P3 intervention, or access to electronic ACOG handouts (active control). Any participating partners are assigned to the same arm as their pregnant partner. The participants in the P3 group will then receive a schedule of automated text messages, with video links, up to twice a day. These videos and messages are based on information relevant to their gestational age. At study entry, participants will complete measures of their health literacy, anxiety, decision self-efficacy, and subjective global health. As pregnancy continues, questionnaires will be sent to participants at the start of their 25th, 30th, and 34th weeks. These questionnaires will include Prematurity Knowledge Questionnaires (specific to their gestational age), a Preparation for Decision Making scale, and an anxiety measure. At study completion, within two weeks of either preterm childbirth or completion of the 34 week questionnaire, participants will be asked to also complete the Educational-Aid Questionnaire.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Birth, Decision Making, Prenatal Care, Resuscitation, Infant, Premature
Keywords
gestational age, multi-media, mobile application, anxiety, clinical trial, random allocation

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
173 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Preemie Prep for Parents (P3) Outpatient Mobile Intervention
Arm Type
Experimental
Arm Description
The P3 mobile intervention in its current form sends participants text messages according to a schedule based on their gestational age. These text messages contain links to short videos uploaded to the P3 site, focusing on topics related to preterm labor and premature infants.
Arm Title
ACOG links
Arm Type
Active Comparator
Arm Description
Participants in the active control condition will receive links to patient education handouts about preterm birth provided by the American College of Obstetricians and Gynecologists.
Intervention Type
Other
Intervention Name(s)
Preemie Prep for Parents (P3) Outpatient Mobile Intervention
Intervention Description
The P3 mobile intervention sends participants text messages according to a schedule based on their gestational age. These text messages contain links to short videos uploaded to the P3 site, focusing on topics related to preterm labor and premature infants.
Intervention Type
Other
Intervention Name(s)
ACOG links
Intervention Description
Participants in the active control condition will receive links to patient education handouts about preterm birth provided by the American College of Obstetricians and Gynecologists.
Primary Outcome Measure Information:
Title
Prematurity Knowledge
Description
Knowledge questionnaire developed by research team and tested through cognitive interviews, testing NICHD-recommended parental prematurity knowledge.
Time Frame
Assessed at participant's 25th week of pregnancy.
Title
Prematurity Knowledge
Description
Knowledge questionnaire developed by research team and tested through cognitive interviews, testing NICHD-recommended parental prematurity knowledge.
Time Frame
Assessed at participant's 30th week of pregnancy.
Title
Prematurity Knowledge
Description
Knowledge questionnaire developed by research team and tested through cognitive interviews, testing NICHD-recommended parental prematurity knowledge.
Time Frame
Assessed at participant's 34th week of pregnancy.
Title
Parental preparation for decision-making
Description
Preparation for Decision Making Scale (Graham, O'Connor 1996, revised 2005). Scale ranges from a score of 10 to 50, with 50 demonstrating maximum preparedness to make a decision.
Time Frame
Assessed at participant's 25th week of pregnancy.
Title
Parental preparation for decision-making
Description
Preparation for Decision Making Scale (Graham, O'Connor 1996, revised 2005). Scale ranges from a score of 10 to 50, with 50 demonstrating maximum preparedness to make a decision.
Time Frame
Assessed at participant's 30th week of pregnancy.
Title
Parental preparation for decision-making
Description
Preparation for Decision Making Scale (Graham, O'Connor 1996, revised 2005). Scale ranges from a score of 10 to 50, with 50 demonstrating maximum preparedness to make a decision.
Time Frame
Assessed at participant's 34th week of pregnancy.
Secondary Outcome Measure Information:
Title
Decision Self-Efficacy
Description
Decision Self-Efficacy Scale (O'Connor, 1995). Scale ranges from a score of 0 to 44. A score of 44 would represent maximum decision self-efficacy.
Time Frame
Assessed at baseline and at 34 weeks of pregnancy.
Title
Anxiety
Description
PROMIS Anxiety Computerized Adaptive Test (CAT). As a Computer Adaptive Test (CAT), not all participants receive the same number of questions, but may range between 4 and 12 questions. The number and selection of questions is dependent on the previous responses. An average US adult has a score of 50 with a standard deviation of 10; the higher that t-score, the greater amount of anxiety the respondent is reporting.
Time Frame
Assessed at baseline and participant's 25th week of pregnancy.
Title
Anxiety
Description
PROMIS Anxiety Computerized Adaptive Test (CAT). As a Computer Adaptive Test (CAT), not all participants receive the same number of questions, but may range between 4 and 12 questions. The number and selection of questions is dependent on the previous responses. An average US adult has a score of 50 with a standard deviation of 10; the higher that t-score, the greater amount of anxiety the respondent is reporting.
Time Frame
Assessed at baseline and participant's 30th week of pregnancy.
Title
Anxiety
Description
PROMIS Anxiety Computerized Adaptive Test (CAT). As a Computer Adaptive Test (CAT), not all participants receive the same number of questions, but may range between 4 and 12 questions. The number and selection of questions is dependent on the previous responses. An average US adult has a score of 50 with a standard deviation of 10; the higher that t-score, the greater amount of anxiety the respondent is reporting.
Time Frame
Assessed at baseline and participant's 34th week of pregnancy.

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
Gender is a de facto criteria of inclusion, in that we will first be recruiting pregnant women. However, her partner or support person, should they wish to participate, may be of any gender.
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Pregnant woman or her partner At risk for preterm birth, as indicated by: history of spontaneous preterm birth (during the 34th week or earlier), shortened cervical length, multiple gestation, fetal growth restriction, chronic hypertension, history of preeclampsia, and/or diabetes requiring medications. Gestational age of 16-21 weeks at recruitment. Owns a smartphone. Able to speak English Exclusion Criteria: • Pregnancies with known significant birth defects.
Facility Information:
Facility Name
Froedtert Hospital
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Preemie Prep For Parents (P3): Home Antenatal Prematurity Education

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