Mobile App for Prenatal Care to Reduce Visits and Improve Satisfaction Study

Pregnancy Clinical Trial

— SPROUT  

Official title:

Effectiveness of a Mobile App for Prenatal Care to Safely Reduce In-Person Visits and Improve Patient Satisfaction: Study Protocol for a Multicenter Prospective Quasi-Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02914301
• Other study ID #: BABYSCRIPTS 1B
• Status: Completed
• Phase: N/A
• Start date: July 2015
• Est. completion date: May 2016

Study information

• Verified date: November 2022
• Source: George Washington University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Prenatal care is defined as preventive healthcare characterized by regular check-ups by doctors or midwives to treat and prevent potential health problems throughout the course of the pregnancy. The investigators propose that a mobile app for prenatal care has the potential to provide patient-tailored, risk-appropriate prenatal educational content and may facilitate vital sign and weight checks between visits. The investigators describe the methods used to develop and test the effectiveness of a mobile app for prenatal care to safely reduce the number of in-person visits to the obstetrician (OB) compared to standard of care.

Description:

This is a protocol for a multi-center quasi-randomized controlled trial to compare an intervention group receiving a prenatal care app, to a control group receiving usual care. The trial is being conducted at two diverse outpatient obstetric practices that are part of a single academic department of obstetrics in Washington, DC. Women who are between 18 and 40, who are visiting their OB for a first trimester routine visit, who have a confirmed desired pregnancy, who are not considered "high-risk," and who have an IOS, Android or Windows-based smart phone that they use regularly will be eligible for enrollment. The Investigators will measure the effect of a mobile app for prenatal care on: 1. the number of in-person OB visits during pregnancy; 2. patient satisfaction with prenatal care; 3. gestational weight gain; 4. maternal and fetal outcomes; and 5. clinician satisfaction. To capture these outcomes, the investigators will administer patient surveys via telephone every 4 weeks during gestation and the immediate post-partum period, review the electronic medical record, and conduct in-depth interviews with a representative subset of patients after delivery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: May 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Eligible participants will be women who are between 18 than 40-years-old, who are visiting the OB for a first-trimester verification of pregnancy visit, new OB visit or follow-up OB visit, who are low-risk per treating OB, who regularly use a smart-phone, who can understand and consent to English-written consent form.
• Eligible clinicians will be attending obstetric physicians who refer the patient to the research assistant for informed consent and full eligibility assessment.

Exclusion Criteria:

• High-risk obstetrical condition*
• Intends midwifery care
• Intends to terminate
• Not Local resident
• Non--English speaker

Related Conditions & MeSH terms

• Pregnancy

Intervention

Device:
• Babyscripts Prenatal App
The use of a mobile digital app to facilitate certain aspects of standard prenatal care.
• Placebo
No Mobile App, Usual care

Locations

Country	Name	City	State
United States	George Washington University Hospital	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Andrew Meltzer	1EQ, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Visit Number	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.	From first trimester up to postpartum, between 6 and 9 months
Secondary	Gestational Weight Gain	We 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.	From first trimester up to postpartum, between 6 and 9 months

External Links

•   site for mobile app