Trial Outcomes & Findings for Preemie Prep For Parents (P3): Home Antenatal Prematurity Education (NCT NCT04093492)

NCT ID: NCT04093492

Last Updated: 2024-03-05

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

175 participants

Primary outcome timeframe

Assessed at participant's 25th week of pregnancy.

Results posted on

2024-03-05

Participant Flow

Participant milestones

Participant milestones
Measure
Preemie Prep for Parents (P3) Outpatient Mobile Intervention - Patients
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. Preemie Prep for Parents (P3) Outpatient Mobile Intervention: 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.
American College of Obstetricians and Gynecologists (ACOG) Links - Patients
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. 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.
Preemie Prep for Parents (P3) Outpatient Mobile Intervention - Support Persons
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. Preemie Prep for Parents (P3) Outpatient Mobile Intervention: 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.
American College of Obstetricians and Gynecologists (ACOG) Links - Support Persons
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. 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.
25 Weeks Gestational Age (GA)
STARTED
60
60
34
21
25 Weeks Gestational Age (GA)
COMPLETED
54
53
29
18
25 Weeks Gestational Age (GA)
NOT COMPLETED
6
7
5
3
30 Weeks GA
STARTED
60
60
34
20
30 Weeks GA
COMPLETED
52
52
29
18
30 Weeks GA
NOT COMPLETED
8
8
5
2
34 Weeks GA
STARTED
60
60
34
20
34 Weeks GA
COMPLETED
54
49
29
17
34 Weeks GA
NOT COMPLETED
6
11
5
3

Reasons for withdrawal

Reasons for withdrawal
Measure
Preemie Prep for Parents (P3) Outpatient Mobile Intervention - Patients
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. Preemie Prep for Parents (P3) Outpatient Mobile Intervention: 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.
American College of Obstetricians and Gynecologists (ACOG) Links - Patients
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. 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.
Preemie Prep for Parents (P3) Outpatient Mobile Intervention - Support Persons
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. Preemie Prep for Parents (P3) Outpatient Mobile Intervention: 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.
American College of Obstetricians and Gynecologists (ACOG) Links - Support Persons
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. 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.
25 Weeks Gestational Age (GA)
Delivered before assessment
1
2
0
0
25 Weeks Gestational Age (GA)
No response
5
5
5
2
25 Weeks Gestational Age (GA)
Withdrawal by Subject
0
0
0
1
30 Weeks GA
Delivered before assessment
1
2
0
0
30 Weeks GA
No response
7
5
5
2
30 Weeks GA
Lost to Follow-up
0
1
0
0
34 Weeks GA
Delivered before assessment
6
3
0
0
34 Weeks GA
No response
0
7
5
3
34 Weeks GA
Lost to Follow-up
0
1
0
0

Baseline Characteristics

Row population is divided by ethnicity (Hispanic/non-Hispanic).

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Preemie Prep for Parents (P3) Outpatient Mobile Intervention - Pregnant Participants
n=60 Participants
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. Preemie Prep for Parents (P3) Outpatient Mobile Intervention: 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.
ACOG Links - Pregnant Participants
n=60 Participants
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. 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.
Preemie Prep for Parents (P3) Outpatient Mobile Intervention - Support Persons
n=34 Participants
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. Preemie Prep for Parents (P3) Outpatient Mobile Intervention: 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.
ACOG Links - Support Persons
n=21 Participants
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. 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.
Total
n=175 Participants
Total of all reporting groups
Age, Customized
20-24 years
5 Participants
n=60 Participants
5 Participants
n=60 Participants
2 Participants
n=34 Participants
1 Participants
n=21 Participants
13 Participants
n=175 Participants
Age, Customized
25-34 years
38 Participants
n=60 Participants
36 Participants
n=60 Participants
13 Participants
n=34 Participants
9 Participants
n=21 Participants
96 Participants
n=175 Participants
Age, Customized
35-46
17 Participants
n=60 Participants
19 Participants
n=60 Participants
17 Participants
n=34 Participants
11 Participants
n=21 Participants
64 Participants
n=175 Participants
Age, Customized
Missing
0 Participants
n=60 Participants
0 Participants
n=60 Participants
2 Participants
n=34 Participants
0 Participants
n=21 Participants
2 Participants
n=175 Participants
Sex: Female, Male
Female
60 Participants
n=60 Participants
60 Participants
n=60 Participants
1 Participants
n=34 Participants
2 Participants
n=21 Participants
123 Participants
n=175 Participants
Sex: Female, Male
Male
0 Participants
n=60 Participants
0 Participants
n=60 Participants
33 Participants
n=34 Participants
19 Participants
n=21 Participants
52 Participants
n=175 Participants
Race/Ethnicity, Customized
non-Hispanic · White
40 Participants
n=57 Participants • Row population is divided by ethnicity (Hispanic/non-Hispanic).
37 Participants
n=53 Participants • Row population is divided by ethnicity (Hispanic/non-Hispanic).
21 Participants
n=28 Participants • Row population is divided by ethnicity (Hispanic/non-Hispanic).
15 Participants
n=20 Participants • Row population is divided by ethnicity (Hispanic/non-Hispanic).
113 Participants
n=158 Participants • Row population is divided by ethnicity (Hispanic/non-Hispanic).
Race/Ethnicity, Customized
non-Hispanic · Black
12 Participants
n=57 Participants • Row population is divided by ethnicity (Hispanic/non-Hispanic).
12 Participants
n=53 Participants • Row population is divided by ethnicity (Hispanic/non-Hispanic).
3 Participants
n=28 Participants • Row population is divided by ethnicity (Hispanic/non-Hispanic).
2 Participants
n=20 Participants • Row population is divided by ethnicity (Hispanic/non-Hispanic).
29 Participants
n=158 Participants • Row population is divided by ethnicity (Hispanic/non-Hispanic).
Race/Ethnicity, Customized
non-Hispanic · American Indian
0 Participants
n=57 Participants • Row population is divided by ethnicity (Hispanic/non-Hispanic).
0 Participants
n=53 Participants • Row population is divided by ethnicity (Hispanic/non-Hispanic).
0 Participants
n=28 Participants • Row population is divided by ethnicity (Hispanic/non-Hispanic).
0 Participants
n=20 Participants • Row population is divided by ethnicity (Hispanic/non-Hispanic).
0 Participants
n=158 Participants • Row population is divided by ethnicity (Hispanic/non-Hispanic).
Race/Ethnicity, Customized
non-Hispanic · Asian
1 Participants
n=57 Participants • Row population is divided by ethnicity (Hispanic/non-Hispanic).
3 Participants
n=53 Participants • Row population is divided by ethnicity (Hispanic/non-Hispanic).
1 Participants
n=28 Participants • Row population is divided by ethnicity (Hispanic/non-Hispanic).
0 Participants
n=20 Participants • Row population is divided by ethnicity (Hispanic/non-Hispanic).
5 Participants
n=158 Participants • Row population is divided by ethnicity (Hispanic/non-Hispanic).
Race/Ethnicity, Customized
non-Hispanic · Native Hawaiian
0 Participants
n=57 Participants • Row population is divided by ethnicity (Hispanic/non-Hispanic).
0 Participants
n=53 Participants • Row population is divided by ethnicity (Hispanic/non-Hispanic).
0 Participants
n=28 Participants • Row population is divided by ethnicity (Hispanic/non-Hispanic).
0 Participants
n=20 Participants • Row population is divided by ethnicity (Hispanic/non-Hispanic).
0 Participants
n=158 Participants • Row population is divided by ethnicity (Hispanic/non-Hispanic).
Race/Ethnicity, Customized
non-Hispanic · More than one race
4 Participants
n=57 Participants • Row population is divided by ethnicity (Hispanic/non-Hispanic).
1 Participants
n=53 Participants • Row population is divided by ethnicity (Hispanic/non-Hispanic).
2 Participants
n=28 Participants • Row population is divided by ethnicity (Hispanic/non-Hispanic).
3 Participants
n=20 Participants • Row population is divided by ethnicity (Hispanic/non-Hispanic).
10 Participants
n=158 Participants • Row population is divided by ethnicity (Hispanic/non-Hispanic).
Race/Ethnicity, Customized
non-Hispanic · Missing
0 Participants
n=57 Participants • Row population is divided by ethnicity (Hispanic/non-Hispanic).
0 Participants
n=53 Participants • Row population is divided by ethnicity (Hispanic/non-Hispanic).
1 Participants
n=28 Participants • Row population is divided by ethnicity (Hispanic/non-Hispanic).
0 Participants
n=20 Participants • Row population is divided by ethnicity (Hispanic/non-Hispanic).
1 Participants
n=158 Participants • Row population is divided by ethnicity (Hispanic/non-Hispanic).
Race/Ethnicity, Customized
Hispanic · White
3 Participants
n=3 Participants • Row population is divided by ethnicity (Hispanic/non-Hispanic).
4 Participants
n=7 Participants • Row population is divided by ethnicity (Hispanic/non-Hispanic).
5 Participants
n=6 Participants • Row population is divided by ethnicity (Hispanic/non-Hispanic).
0 Participants
n=1 Participants • Row population is divided by ethnicity (Hispanic/non-Hispanic).
12 Participants
n=17 Participants • Row population is divided by ethnicity (Hispanic/non-Hispanic).
Race/Ethnicity, Customized
Hispanic · Black
0 Participants
n=3 Participants • Row population is divided by ethnicity (Hispanic/non-Hispanic).
2 Participants
n=7 Participants • Row population is divided by ethnicity (Hispanic/non-Hispanic).
0 Participants
n=6 Participants • Row population is divided by ethnicity (Hispanic/non-Hispanic).
0 Participants
n=1 Participants • Row population is divided by ethnicity (Hispanic/non-Hispanic).
2 Participants
n=17 Participants • Row population is divided by ethnicity (Hispanic/non-Hispanic).
Race/Ethnicity, Customized
Hispanic · American Indian
0 Participants
n=3 Participants • Row population is divided by ethnicity (Hispanic/non-Hispanic).
0 Participants
n=7 Participants • Row population is divided by ethnicity (Hispanic/non-Hispanic).
0 Participants
n=6 Participants • Row population is divided by ethnicity (Hispanic/non-Hispanic).
0 Participants
n=1 Participants • Row population is divided by ethnicity (Hispanic/non-Hispanic).
0 Participants
n=17 Participants • Row population is divided by ethnicity (Hispanic/non-Hispanic).
Race/Ethnicity, Customized
Hispanic · Asian
0 Participants
n=3 Participants • Row population is divided by ethnicity (Hispanic/non-Hispanic).
1 Participants
n=7 Participants • Row population is divided by ethnicity (Hispanic/non-Hispanic).
0 Participants
n=6 Participants • Row population is divided by ethnicity (Hispanic/non-Hispanic).
1 Participants
n=1 Participants • Row population is divided by ethnicity (Hispanic/non-Hispanic).
2 Participants
n=17 Participants • Row population is divided by ethnicity (Hispanic/non-Hispanic).
Race/Ethnicity, Customized
Hispanic · Native Hawaiian
0 Participants
n=3 Participants • Row population is divided by ethnicity (Hispanic/non-Hispanic).
0 Participants
n=7 Participants • Row population is divided by ethnicity (Hispanic/non-Hispanic).
0 Participants
n=6 Participants • Row population is divided by ethnicity (Hispanic/non-Hispanic).
0 Participants
n=1 Participants • Row population is divided by ethnicity (Hispanic/non-Hispanic).
0 Participants
n=17 Participants • Row population is divided by ethnicity (Hispanic/non-Hispanic).
Race/Ethnicity, Customized
Hispanic · More than one race
0 Participants
n=3 Participants • Row population is divided by ethnicity (Hispanic/non-Hispanic).
0 Participants
n=7 Participants • Row population is divided by ethnicity (Hispanic/non-Hispanic).
0 Participants
n=6 Participants • Row population is divided by ethnicity (Hispanic/non-Hispanic).
0 Participants
n=1 Participants • Row population is divided by ethnicity (Hispanic/non-Hispanic).
0 Participants
n=17 Participants • Row population is divided by ethnicity (Hispanic/non-Hispanic).
Race/Ethnicity, Customized
Hispanic · Missing
0 Participants
n=3 Participants • Row population is divided by ethnicity (Hispanic/non-Hispanic).
0 Participants
n=7 Participants • Row population is divided by ethnicity (Hispanic/non-Hispanic).
1 Participants
n=6 Participants • Row population is divided by ethnicity (Hispanic/non-Hispanic).
0 Participants
n=1 Participants • Row population is divided by ethnicity (Hispanic/non-Hispanic).
1 Participants
n=17 Participants • Row population is divided by ethnicity (Hispanic/non-Hispanic).
Gestational age at enrollment
16 weeks GA
5 Participants
n=60 Participants
3 Participants
n=60 Participants
3 Participants
n=34 Participants
1 Participants
n=21 Participants
12 Participants
n=175 Participants
Gestational age at enrollment
17 weeks GA
18 Participants
n=60 Participants
18 Participants
n=60 Participants
9 Participants
n=34 Participants
7 Participants
n=21 Participants
52 Participants
n=175 Participants
Gestational age at enrollment
18 weeks GA
8 Participants
n=60 Participants
10 Participants
n=60 Participants
6 Participants
n=34 Participants
3 Participants
n=21 Participants
27 Participants
n=175 Participants
Gestational age at enrollment
19 weeks GA
3 Participants
n=60 Participants
3 Participants
n=60 Participants
0 Participants
n=34 Participants
1 Participants
n=21 Participants
7 Participants
n=175 Participants
Gestational age at enrollment
20 weeks GA
15 Participants
n=60 Participants
12 Participants
n=60 Participants
12 Participants
n=34 Participants
4 Participants
n=21 Participants
43 Participants
n=175 Participants
Gestational age at enrollment
21 weeks GA
9 Participants
n=60 Participants
11 Participants
n=60 Participants
3 Participants
n=34 Participants
4 Participants
n=21 Participants
27 Participants
n=175 Participants
Gestational age at enrollment
22 weeks GA
2 Participants
n=60 Participants
3 Participants
n=60 Participants
1 Participants
n=34 Participants
1 Participants
n=21 Participants
7 Participants
n=175 Participants
Education
9-12th grade, no diploma
0 Participants
n=60 Participants
2 Participants
n=60 Participants
0 Participants
n=34 Participants
0 Participants
n=21 Participants
2 Participants
n=175 Participants
Education
High school diploma or equivalent
8 Participants
n=60 Participants
10 Participants
n=60 Participants
4 Participants
n=34 Participants
3 Participants
n=21 Participants
25 Participants
n=175 Participants
Education
Some college
13 Participants
n=60 Participants
9 Participants
n=60 Participants
11 Participants
n=34 Participants
3 Participants
n=21 Participants
36 Participants
n=175 Participants
Education
2-year degree
7 Participants
n=60 Participants
8 Participants
n=60 Participants
5 Participants
n=34 Participants
1 Participants
n=21 Participants
21 Participants
n=175 Participants
Education
4-year degree
17 Participants
n=60 Participants
16 Participants
n=60 Participants
11 Participants
n=34 Participants
6 Participants
n=21 Participants
50 Participants
n=175 Participants
Education
Graduate or professional degree
15 Participants
n=60 Participants
15 Participants
n=60 Participants
3 Participants
n=34 Participants
8 Participants
n=21 Participants
41 Participants
n=175 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Preemie Prep for Parents (P3) Outpatient Mobile Intervention - Pregnant Participants
n=54 Participants
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. Preemie Prep for Parents (P3) Outpatient Mobile Intervention: 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.
ACOG Links - Pregnant Participants
n=53 Participants
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. 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.
Preemie Prep for Parents (P3) Outpatient Mobile Intervention - Support Persons
n=29 Participants
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. Preemie Prep for Parents (P3) Outpatient Mobile Intervention: 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.
ACOG Links - Support Persons
n=19 Participants
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. 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.
Parent Prematurity Knowledge Questionnaire
30.3 score on a scale
Standard Deviation 5.7
22.8 score on a scale
Standard Deviation 5.9
29.3 score on a scale
Standard Deviation 7.1
25.6 score on a scale
Standard Deviation 4.1

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Preemie Prep for Parents (P3) Outpatient Mobile Intervention - Pregnant Participants
n=52 Participants
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. Preemie Prep for Parents (P3) Outpatient Mobile Intervention: 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.
ACOG Links - Pregnant Participants
n=52 Participants
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. 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.
Preemie Prep for Parents (P3) Outpatient Mobile Intervention - Support Persons
n=29 Participants
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. Preemie Prep for Parents (P3) Outpatient Mobile Intervention: 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.
ACOG Links - Support Persons
n=19 Participants
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. 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.
Parent Prematurity Knowledge Questionnaire
29.2 score on a scale
Standard Deviation 3.6
23.9 score on a scale
Standard Deviation 5.1
27.9 score on a scale
Standard Deviation 4.6
25.7 score on a scale
Standard Deviation 3.5

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Preemie Prep for Parents (P3) Outpatient Mobile Intervention - Pregnant Participants
n=54 Participants
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. Preemie Prep for Parents (P3) Outpatient Mobile Intervention: 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.
ACOG Links - Pregnant Participants
n=49 Participants
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. 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.
Preemie Prep for Parents (P3) Outpatient Mobile Intervention - Support Persons
n=29 Participants
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. Preemie Prep for Parents (P3) Outpatient Mobile Intervention: 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.
ACOG Links - Support Persons
n=17 Participants
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. 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.
Parent Prematurity Knowledge Questionnaire
25.8 score on a scale
Standard Deviation 3.5
21.3 score on a scale
Standard Deviation 4.8
24.2 score on a scale
Standard Deviation 3.4
20.5 score on a scale
Standard Deviation 6.3

PRIMARY outcome

Timeframe: Assessed at participant's 25th 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.

Outcome measures

Outcome measures
Measure
Preemie Prep for Parents (P3) Outpatient Mobile Intervention - Pregnant Participants
n=54 Participants
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. Preemie Prep for Parents (P3) Outpatient Mobile Intervention: 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.
ACOG Links - Pregnant Participants
n=53 Participants
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. 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.
Preemie Prep for Parents (P3) Outpatient Mobile Intervention - Support Persons
n=28 Participants
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. Preemie Prep for Parents (P3) Outpatient Mobile Intervention: 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.
ACOG Links - Support Persons
n=19 Participants
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. 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.
Preparation for Decision Making Scale
76.0 score on a scale
Standard Deviation 18.3
52.3 score on a scale
Standard Deviation 29.5
76.8 score on a scale
Standard Deviation 16.3
57.1 score on a scale
Standard Deviation 31.2

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Preemie Prep for Parents (P3) Outpatient Mobile Intervention - Pregnant Participants
n=52 Participants
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. Preemie Prep for Parents (P3) Outpatient Mobile Intervention: 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.
ACOG Links - Pregnant Participants
n=52 Participants
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. 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.
Preemie Prep for Parents (P3) Outpatient Mobile Intervention - Support Persons
n=29 Participants
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. Preemie Prep for Parents (P3) Outpatient Mobile Intervention: 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.
ACOG Links - Support Persons
n=18 Participants
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. 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.
Preparation for Decision Making Scale
76.3 score on a scale
Standard Deviation 24.8
54.4 score on a scale
Standard Deviation 25.1
69.2 score on a scale
Standard Deviation 23.6
61.1 score on a scale
Standard Deviation 14.9

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Preemie Prep for Parents (P3) Outpatient Mobile Intervention - Pregnant Participants
n=54 Participants
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. Preemie Prep for Parents (P3) Outpatient Mobile Intervention: 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.
ACOG Links - Pregnant Participants
n=49 Participants
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. 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.
Preemie Prep for Parents (P3) Outpatient Mobile Intervention - Support Persons
n=29 Participants
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. Preemie Prep for Parents (P3) Outpatient Mobile Intervention: 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.
ACOG Links - Support Persons
n=16 Participants
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. 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.
Preparation for Decision Making Scale
68.9 score on a scale
Standard Deviation 25.1
54.2 score on a scale
Standard Deviation 28.5
69.3 score on a scale
Standard Deviation 24.0
63.6 score on a scale
Standard Deviation 23.7

SECONDARY outcome

Timeframe: Assessed at baseline

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.

Outcome measures

Outcome measures
Measure
Preemie Prep for Parents (P3) Outpatient Mobile Intervention - Pregnant Participants
n=60 Participants
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. Preemie Prep for Parents (P3) Outpatient Mobile Intervention: 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.
ACOG Links - Pregnant Participants
n=60 Participants
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. 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.
Preemie Prep for Parents (P3) Outpatient Mobile Intervention - Support Persons
n=33 Participants
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. Preemie Prep for Parents (P3) Outpatient Mobile Intervention: 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.
ACOG Links - Support Persons
n=21 Participants
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. 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.
Anxiety
53.7 T-score
Standard Deviation 7.8
54.6 T-score
Standard Deviation 8.2
49.9 T-score
Standard Deviation 5.6
52.3 T-score
Standard Deviation 8.7

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Preemie Prep for Parents (P3) Outpatient Mobile Intervention - Pregnant Participants
n=54 Participants
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. Preemie Prep for Parents (P3) Outpatient Mobile Intervention: 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.
ACOG Links - Pregnant Participants
n=53 Participants
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. 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.
Preemie Prep for Parents (P3) Outpatient Mobile Intervention - Support Persons
n=29 Participants
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. Preemie Prep for Parents (P3) Outpatient Mobile Intervention: 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.
ACOG Links - Support Persons
n=19 Participants
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. 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.
Anxiety
53.6 T-score
Standard Deviation 7.9
53.8 T-score
Standard Deviation 8.2
49.5 T-score
Standard Deviation 7.2
52.4 T-score
Standard Deviation 6.4

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Preemie Prep for Parents (P3) Outpatient Mobile Intervention - Pregnant Participants
n=52 Participants
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. Preemie Prep for Parents (P3) Outpatient Mobile Intervention: 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.
ACOG Links - Pregnant Participants
n=52 Participants
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. 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.
Preemie Prep for Parents (P3) Outpatient Mobile Intervention - Support Persons
n=29 Participants
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. Preemie Prep for Parents (P3) Outpatient Mobile Intervention: 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.
ACOG Links - Support Persons
n=20 Participants
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. 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.
Anxiety
52.7 T-score
Standard Deviation 7.7
55.3 T-score
Standard Deviation 6.8
48.5 T-score
Standard Deviation 7.9
53.0 T-score
Standard Deviation 8.6

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Preemie Prep for Parents (P3) Outpatient Mobile Intervention - Pregnant Participants
n=54 Participants
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. Preemie Prep for Parents (P3) Outpatient Mobile Intervention: 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.
ACOG Links - Pregnant Participants
n=49 Participants
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. 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.
Preemie Prep for Parents (P3) Outpatient Mobile Intervention - Support Persons
n=29 Participants
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. Preemie Prep for Parents (P3) Outpatient Mobile Intervention: 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.
ACOG Links - Support Persons
n=16 Participants
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. 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.
Anxiety
53.5 T-score
Standard Deviation 9.2
55.5 T-score
Standard Deviation 8.2
50.9 T-score
Standard Deviation 9.0
53.0 T-score
Standard Deviation 7.2

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Preemie Prep for Parents (P3) Outpatient Mobile Intervention - Pregnant Participants
n=60 Participants
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. Preemie Prep for Parents (P3) Outpatient Mobile Intervention: 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.
ACOG Links - Pregnant Participants
n=60 Participants
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. 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.
Preemie Prep for Parents (P3) Outpatient Mobile Intervention - Support Persons
n=38 Participants
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. Preemie Prep for Parents (P3) Outpatient Mobile Intervention: 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.
ACOG Links - Support Persons
n=16 Participants
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. 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.
Decision Self-Efficacy
92.1 score on a scale
Standard Deviation 11.3
91.6 score on a scale
Standard Deviation 10.3
88.3 score on a scale
Standard Deviation 13.4
95.0 score on a scale
Standard Deviation 8.2

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Preemie Prep for Parents (P3) Outpatient Mobile Intervention - Pregnant Participants
n=54 Participants
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. Preemie Prep for Parents (P3) Outpatient Mobile Intervention: 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.
ACOG Links - Pregnant Participants
n=49 Participants
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. 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.
Preemie Prep for Parents (P3) Outpatient Mobile Intervention - Support Persons
n=29 Participants
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. Preemie Prep for Parents (P3) Outpatient Mobile Intervention: 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.
ACOG Links - Support Persons
n=16 Participants
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. 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.
Decision Self-Efficacy
89.3 score on a scale
Standard Deviation 12.1
85.8 score on a scale
Standard Deviation 17.6
86.8 score on a scale
Standard Deviation 12.3
86.8 score on a scale
Standard Deviation 15.2

Adverse Events

Preemie Prep for Parents (P3) Outpatient Mobile Intervention

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

ACOG Links

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Mir A Basir

Medical College of Wisconsin

Phone: 414-266-6820

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place