Clinical trial NCT02914301: Mobile App for Prenatal Care to Reduce Visits and Improve Satisfaction Study
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Lead sponsor: George Washington University
Sponsor class: OTHER
Collaborators: name: 1EQ, Inc.
First posted: 2016-09-26
Enrollment: 118
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Total Visit Number
timeFrame: From first trimester up to postpartum, between 6 and 9 months
Secondary outcomes:
measure: Gestational Weight Gain
timeFrame: From first trimester up to postpartum, between 6 and 9 months
Other outcomes:
Locations:
city: Washington
country: United States
facility: George Washington University Hospital
state: District of Columbia
Study officials:
affiliation: The George Washington University
name: Andrew C Meltzer, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Marko KI, Ganju N, Krapf JM, Gaba ND, Brown JA, Benham JJ, Oh J, Richards LM, Meltzer AC. A Mobile Prenatal Care App to Reduce In-Person Visits: Prospective Controlled Trial. JMIR Mhealth Uhealth. 2019 May 1;7(5):e10520. doi: 10.2196/10520.