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

Andrew Meltzer

Status: Completed

Conditions: Pregnancy

Treatments: Device: Placebo; Device: Babyscripts Prenatal App

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02914301

BABYSCRIPTS 1B

Details and patient eligibility

About

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.

Full 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.

Enrollment: 118 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

118 participants in 2 patient groups, including a placebo group

Babyscripts Prenatal App

Active Comparator group

Description:

For patients allocated to the experimental 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 allocated to this study arm, the clinician will be informed and therefore, will be receiving regular app-based education while the 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.

Treatment:

Device: Babyscripts Prenatal App

Placebo

Placebo Comparator group

Description:

For patients cared for by clinicians allocated to the control (usual care) arm, the clinician will discuss the management options and scheduling procedures with the patient 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.

Treatment:

Device: Placebo