- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04093492
Preemie Prep For Parents (P3): Home Antenatal Prematurity Education
Preemie Prep For Parents (P3) Outpatient Mobile Intervention: Home Antenatal Prematurity Education
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Wisconsin
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Milwaukee, Wisconsin, United States, 53226
- Froedtert Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Preemie Prep for Parents (P3) Outpatient Mobile Intervention
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.
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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.
|
Active Comparator: ACOG links
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Parent Prematurity Knowledge Questionnaire
Time Frame: Assessed at participant's 25th week of pregnancy.
|
Knowledge questionnaire developed by research team and tested through cognitive interviews, testing parental prematurity knowledge recommended by Eunice Kennedy Shriver National Institute of Child Health and Human Development.
Subscales consist of long-term outcomes, variability in due date estimation, general prematurity knowledge, lowest gestational age needed for survival, factors influencing preterm birth outcome, treatment options, short-term outcomes, and advocacy.
Subscale scores are summed to create a composite score.
Versions of the questionnaire are slightly different at follow up points to ensure gestational age specific clinical relevance; the version at 25 weeks the questionnaire has 38 items.
Therefore the range of scores is from 0-38, with higher scores indicating greater knowledge.
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Assessed at participant's 25th week of pregnancy.
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Parent Prematurity Knowledge Questionnaire
Time Frame: Assessed at participant's 30th week of pregnancy.
|
Knowledge questionnaire developed by research team and tested through cognitive interviews, testing parental prematurity knowledge recommended by Eunice Kennedy Shriver National Institute of Child Health and Human Development.
Subscales consist of long-term outcomes, variability in due date estimation, general prematurity knowledge, lowest gestational age needed for survival, factors influencing preterm birth outcome, treatment options, short-term outcomes, and advocacy.
Subscale scores are summed to create a composite score.
Versions of the questionnaire are slightly different at follow up points to ensure gestational age specific clinical relevance; the version at 30 weeks the questionnaire has 35 items.
Therefore the range of scores is from 0-35, with higher scores indicating greater knowledge.
|
Assessed at participant's 30th week of pregnancy.
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Parent Prematurity Knowledge Questionnaire
Time Frame: Assessed at participant's 34th week of pregnancy.
|
Knowledge questionnaire developed by research team and tested through cognitive interviews, testing parental prematurity knowledge recommended by Eunice Kennedy Shriver National Institute of Child Health and Human Development.
Subscales consist of long-term outcomes, variability in due date estimation, general prematurity knowledge, lowest gestational age needed for survival, factors influencing preterm birth outcome, treatment options, short-term outcomes, and advocacy.
Subscale scores are summed to create a composite score.
Versions of the questionnaire are slightly different at follow up points to ensure gestational age specific clinical relevance; the version at 34 weeks the questionnaire has 30 items.
Therefore the range of scores is from 0-30, with higher scores indicating greater knowledge.
|
Assessed at participant's 34th week of pregnancy.
|
Preparation for Decision Making Scale
Time Frame: Assessed at participant's 25th week of pregnancy.
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Preparation for Decision Making Scale (Graham, O'Connor 1996, revised 2005).
Scale ranges from a score of 10 to 50; these scores are converted to a 0-100 scale for ease of interpretation as recommended by the creators.
Higher scores indicate higher perceived level of preparation for discussing a healthcare related decision.
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Assessed at participant's 25th week of pregnancy.
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Preparation for Decision Making Scale
Time Frame: Assessed at participant's 30th week of pregnancy.
|
Preparation for Decision Making Scale (Graham, O'Connor 1996, revised 2005).
Scale ranges from a score of 10 to 50; these scores are converted to a 0-100 scale for ease of interpretation as recommended by the creators.
Higher scores indicate higher perceived level of preparation for discussing a healthcare related decision.
|
Assessed at participant's 30th week of pregnancy.
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Preparation for Decision Making Scale
Time Frame: Assessed at participant's 34th week of pregnancy.
|
Preparation for Decision Making Scale (Graham, O'Connor 1996, revised 2005).
Scale ranges from a score of 10 to 50; these scores are converted to a 0-100 scale for ease of interpretation as recommended by the creators.
Higher scores indicate higher perceived level of preparation for discussing a healthcare related decision.
|
Assessed at participant's 34th week of pregnancy.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Anxiety
Time Frame: Assessed at baseline
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Patient-Reported Outcomes Measurement Information System (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.
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Assessed at baseline
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Anxiety
Time Frame: Assessed at participant's 25th week of pregnancy.
|
Patient-Reported Outcomes Measurement Information System (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.
|
Assessed at participant's 25th week of pregnancy.
|
Anxiety
Time Frame: Assessed at participant's 30th week of pregnancy.
|
Patient-Reported Outcomes Measurement Information System (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.
|
Assessed at participant's 30th week of pregnancy.
|
Anxiety
Time Frame: Assessed at participant's 34th week of pregnancy.
|
Patient-Reported Outcomes Measurement Information System (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.
|
Assessed at participant's 34th week of pregnancy.
|
Decision Self-Efficacy
Time Frame: Assessed at baseline
|
Decision Self-Efficacy Scale (O'Connor, 1995).
Scale ranges from a score of 0 to 44; these scores are converted to a 0-100 scale for ease of interpretation as recommended by the creators.
Higher scores indicate higher perceived level of decision self-efficacy.
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Assessed at baseline
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Decision Self-Efficacy
Time Frame: Assessed at 34 weeks of pregnancy
|
Decision Self-Efficacy Scale (O'Connor, 1995).
Scale ranges from a score of 0 to 44; these scores are converted to a 0-100 scale for ease of interpretation as recommended by the creators.
Higher scores indicate higher perceived level of decision self-efficacy.
|
Assessed at 34 weeks of pregnancy
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PRO00033902
- R21HD092664 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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