Telehealth Multi-Component Optional Model (MOM) Study

NCT06095960 | Recruiting

• 1 other identifier: 276311
• Study Type: interventional
• Target: 1,500
• Locations: 1 country
• Sites: 6

Brief Summary

The aim of this study is to conduct a comparative effectiveness evaluation using a randomized control trail design among diverse women to compare two postpartum care models: 1) Telehealth Multicomponent Optimal Model (Telehealth MOM) and 2) enhanced standard of care (ESoC). This study will address critical gaps in knowledge about how best to deliver comprehensive postpartum care that ensures timely identification and treatment of complications and meets the needs and preferences of diverse patients, including disproportionately-impacted racial groups and rural residents.

Conditions

Maternal Health

Outcome Measures

Primary Outcomes (1)

• Completion of post-partum 6-week comprehensive visit

  Binary measure (yes/no) of visit completion

  Baseline to 6 weeks post-partum

Study Arms (2)

Telehealth MOM

EXPERIMENTAL

Telehealth MOM. Each patient will receive ESoC which includes: education on the symptoms to watch for and when to call their healthcare provider, an in-person comprehensive postpartum visit around 6 weeks postpartum, and any additional care deemed necessary by their health care providers. Patients in the Telehealth MOM arm will be also provided with a remote monitoring blood pressure cuff and thermometer and will be instructed to take their blood pressure and temperature twice a day for 14 days after discharge from the hospital. A Registered Nurse will monitor blood pressure and temperature readings over the 14-day period and will contact the patient if the readings are out of range to discuss symptoms and the recommend a course of action. A Registered Nurse will conduct an early postpartum telehealth visit between 10-14 days postpartum.

Behavioral: Telehealth MOM

Enhanced Standard of Care

ACTIVE COMPARATOR

Enhanced standard of care (ESoC). Each patient will be provided education on the symptoms to watch for and when to call their healthcare provider. Patients will be scheduled for a comprehensive postpartum visit around 6 weeks postpartum and any additional care deemed necessary by their health care providers.

Other: Enhanced Standard of Care

Interventions

Enhanced Standard of Care OTHER

Patients will receive enhanced standard of care which includes: education on symptoms and when to call their healthcare provider, comprehensive 6-week post-partum visit, and any healthcare deemed necessary by providers.

Enhanced Standard of Care

Telehealth MOM BEHAVIORAL

Patients will receive enhanced standard of care plus remote blood pressure monitoring, remote thermometer, and a 10- to 14-day post-partum telehealth visit.

Telehealth MOM

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant women between 16-35 weeks gestation
• Age 18-44 years
• Ability to speak English, Spanish, or Marshallese
• Participants may have either a vaginal birth or cesarean section birth

You may not qualify if:

• Type 1 diabetes on an insulin pump followed closely by endocrinology
• Uncontrolled Type 2 diabetes
• End stage renal disease followed closely by nephrology
• ICU admission at any point during pregnancy or delivery hospitalization
• Other maternal conditions requiring additional surgeries (i.e. cesarean hysterectomy or intrapartum or postpartum oophorectomy/appendectomy)
• Incarceration
• Mental disability limiting decision-making capacity
• Uncontrolled chronic hypertension
• HELLP syndrome during pregnancy
• Sickle cell disease
• Maternal heart condition or heart disease
• Opioid use disorder
• Lupus
• Thrombophilia or blood clots
• Need for blood transfusion during delivery hospitalization

Sponsors & Collaborators

• University of Arkansas: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (6)

UAMS El Dorado FMC

El Dorado, Arkansas, 71730, United States

NOT YET RECRUITING

UAMS Fayetteville FMC

Fayetteville, Arkansas, 72703, United States

RECRUITING

UAMS Fort Smith FMC

Fort Smith, Arkansas, 72901, United States

RECRUITING

UAMS Jonesboro FMC

Jonesboro, Arkansas, 72401, United States

NOT YET RECRUITING

UAMS Health Women's Center

Little Rock, Arkansas, 72205, United States

RECRUITING

UAMS Springdale FMC

Springdale, Arkansas, 72764, United States

RECRUITING

Study Officials

• Jennifer Callaghan-Koru, PhD

  University of Arkansas

  PRINCIPAL INVESTIGATOR

• Pearl McElfish, PhD

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brett Rowland, MA

CONTACT

4797138661; mbrowland@uams.edu

Kacie Simpson, BS

CONTACT

4797138661; klsimpson@uams.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2023
• First Posted: October 23, 2023
• Study Start: February 12, 2024
• Primary Completion (Estimated): January 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)