Trial Outcomes & Findings for Mobile App for Prenatal Care to Reduce Visits and Improve Satisfaction Study (NCT NCT02914301)
NCT ID: NCT02914301
Last Updated: 2022-12-16
Results Overview
In discussions with OBs, it became clear that, patient safety notwithstanding, the advantages and disadvantages of a reduced visit schedule versus usual care were of greatest importance and so total visit number was selected as the primary outcome. We will measure total visit number by reviewing the EHR. All other outcomes will be secondary outcomes.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
118 participants
Primary outcome timeframe
From first trimester up to postpartum, between 6 and 9 months
Results posted on
2022-12-16
Participant Flow
Participant milestones
| Measure |
Babyscripts Prenatal App
For patients allocated to the study group, they will be assisted in downloading the BRx app to their smartphone and set up the connected weight scale and blood pressure cuff. At time of enrollment, research assistant will also collect baseline demographic and clinical data. For patients who were allocated to the intervention arm, the clinician will told that they are in intervention group and therefore will be receiving regular app-based education and clinician will be receiving regular blood pressure and weight measurements. Following that communication, it will be the physicians' judgement to reduce in-person visits from usual care.
Babyscripts Prenatal App: The use of a mobile digital app to facilitate certain aspects of standard prenatal care.
|
Placebo
For patients cared for by clinicians allocated to the usual care arm, the clinician will discuss the management options and scheduling procedures with the parent in that clinician's usual fashion. The patient will not be given access to the BRx app but will consent to the study data collection and survey administration. All potential study subjects will receive standard medical care per DoD/VA Clinical Practice Guidelines for Management of the uncomplicated pregnancy (REF) and local preference by board-certified OB/GYN physicians.
Placebo: No Mobile App, Usual care
|
|---|---|---|
|
Overall Study
STARTED
|
60
|
58
|
|
Overall Study
COMPLETED
|
47
|
41
|
|
Overall Study
NOT COMPLETED
|
13
|
17
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Mobile App for Prenatal Care to Reduce Visits and Improve Satisfaction Study
Baseline characteristics by cohort
| Measure |
Babyscripts Prenatal App
n=47 Participants
For patients allocated to the study group, they will be assisted in downloading the BRx app to their smartphone and set up the connected weight scale and blood pressure cuff. At time of enrollment, research assistant will also collect baseline demographic and clinical data. For patients who were allocated to the intervention arm, the clinician will told that they are in intervention group and therefore will be receiving regular app-based education and clinician will be receiving regular blood pressure and weight measurements. Following that communication, it will be the physicians' judgement to reduce in-person visits from usual care.
Babyscripts Prenatal App: The use of a mobile digital app to facilitate certain aspects of standard prenatal care.
|
Placebo
n=41 Participants
For patients cared for by clinicians allocated to the usual care arm, the clinician will discuss the management options and scheduling procedures with the parent in that clinician's usual fashion. The patient will not be given access to the BRx app but will consent to the study data collection and survey administration. All potential study subjects will receive standard medical care per DoD/VA Clinical Practice Guidelines for Management of the uncomplicated pregnancy (REF) and local preference by board-certified OB/GYN physicians.
Placebo: No Mobile App, Usual care
|
Total
n=88 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
33.0 years
STANDARD_DEVIATION 3.3 • n=5 Participants
|
32.2 years
STANDARD_DEVIATION 3.2 • n=7 Participants
|
32.6 years
STANDARD_DEVIATION 3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
47 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
88 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African-American
|
14 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
33 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
47 participants
n=5 Participants
|
41 participants
n=7 Participants
|
88 participants
n=5 Participants
|
|
College Graduate
|
45 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
|
Gravidity Per Patient
One
|
25 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Gravidity Per Patient
Greater than One
|
22 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Parity Per Patient
Zero
|
30 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Parity Per Patient
Greater than One
|
17 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From first trimester up to postpartum, between 6 and 9 monthsIn discussions with OBs, it became clear that, patient safety notwithstanding, the advantages and disadvantages of a reduced visit schedule versus usual care were of greatest importance and so total visit number was selected as the primary outcome. We will measure total visit number by reviewing the EHR. All other outcomes will be secondary outcomes.
Outcome measures
| Measure |
Babyscripts Prenatal App
n=45 Participants
For patients allocated to the study group, they will be assisted in downloading the BRx app to their smartphone and set up the connected weight scale and blood pressure cuff. At time of enrollment, research assistant will also collect baseline demographic and clinical data. For patients who were allocated to the intervention arm, the clinician will told that they are in intervention group and therefore will be receiving regular app-based education and clinician will be receiving regular blood pressure and weight measurements. Following that communication, it will be the physicians' judgement to reduce in-person visits from usual care.
Babyscripts Prenatal App: The use of a mobile digital app to facilitate certain aspects of standard prenatal care.
|
Placebo
n=51 Participants
For patients cared for by clinicians allocated to the usual care arm, the clinician will discuss the management options and scheduling procedures with the parent in that clinician's usual fashion. The patient will not be given access to the BRx app but will consent to the study data collection and survey administration. All potential study subjects will receive standard medical care per DoD/VA Clinical Practice Guidelines for Management of the uncomplicated pregnancy (REF) and local preference by board-certified OB/GYN physicians.
Placebo: No Mobile App, Usual care
|
|---|---|---|
|
Total Visit Number
|
7.9 visits
Standard Deviation 1.8
|
10.2 visits
Standard Deviation 1.8
|
SECONDARY outcome
Timeframe: From first trimester up to postpartum, between 6 and 9 monthsWe will assess gestational weight gain following enrollment until delivery. These measures will be obtained by health record review and review of data collected in the app. Data collection will be performed with a standardized data collection sheet and a 10% check for interrater reliability.
Outcome measures
| Measure |
Babyscripts Prenatal App
n=45 Participants
For patients allocated to the study group, they will be assisted in downloading the BRx app to their smartphone and set up the connected weight scale and blood pressure cuff. At time of enrollment, research assistant will also collect baseline demographic and clinical data. For patients who were allocated to the intervention arm, the clinician will told that they are in intervention group and therefore will be receiving regular app-based education and clinician will be receiving regular blood pressure and weight measurements. Following that communication, it will be the physicians' judgement to reduce in-person visits from usual care.
Babyscripts Prenatal App: The use of a mobile digital app to facilitate certain aspects of standard prenatal care.
|
Placebo
n=51 Participants
For patients cared for by clinicians allocated to the usual care arm, the clinician will discuss the management options and scheduling procedures with the parent in that clinician's usual fashion. The patient will not be given access to the BRx app but will consent to the study data collection and survey administration. All potential study subjects will receive standard medical care per DoD/VA Clinical Practice Guidelines for Management of the uncomplicated pregnancy (REF) and local preference by board-certified OB/GYN physicians.
Placebo: No Mobile App, Usual care
|
|---|---|---|
|
Gestational Weight Gain
Underweight (BMI< 18.5)
|
22.9 pounds
Standard Deviation 13.4
|
20.9 pounds
Standard Deviation 4.8
|
|
Gestational Weight Gain
Normal (18.5<BMI<25)
|
34.0 pounds
Standard Deviation 8.4
|
30.5 pounds
Standard Deviation 7.7
|
|
Gestational Weight Gain
Overweight (25<BMI<30)
|
35.0 pounds
Standard Deviation 10.8
|
24.2 pounds
Standard Deviation 11.2
|
|
Gestational Weight Gain
Obese (BMI>30)
|
13.0 pounds
Standard Deviation 0
|
9.4 pounds
Standard Deviation 9.6
|
Adverse Events
Babyscripts Prenatal App
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
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. Andrew C. Meltzer
George Washington University School of Medicine & Health Sciences- Department of Emergency Medicine
Phone: 202-741-2952
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place