Comparative Evaluation of Telehealth Multi-Component Optional Model (MOM) of Postpartum Care Among Rural, Low-income, and Diverse Women
| Registry | NCT06095960 |
|---|---|
| Status | Recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: single, supportive care |
| Enrollment | 1500 (Estimated) |
| Sponsor | University of Arkansas (Other); collaborators: Patient-Centered Outcomes Research Institute |
| Conditions | Maternal Health |
| Interventions | Telehealth MOM, Enhanced Standard of Care (Behavioral, other) |
| Dates | start 2024-02-12, primary completion 2027-01-30 (estimated), completion 2027-12-31 (estimated), first posted 2023-10-23, last updated 2026-02-05 |
| Locations | 6 sites in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Maternal Health All trials of Telehealth MOM All trials of Enhanced Standard of Care
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Telehealth MOM | Experimental | Behavioral: Telehealth MOM | 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. |
| Enhanced Standard of Care | Active comparator | Other: Enhanced Standard of Care | 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. |
Sex: Female, ages: 18 Years to 44 Years, accepts healthy volunteers
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * Other maternal conditions or complications, known during pregnancy or delivery hospitalization, requiring prolonged hospitalization postpartum
| Facility | City | Country | Status |
|---|---|---|---|
| UAMS El Dorado FMC | El Dorado, Arkansas | United States | Not yet recruiting |
| UAMS Fayetteville FMC | Fayetteville, Arkansas | United States | Recruiting |
| UAMS Fort Smith FMC | Fort Smith, Arkansas | United States | Recruiting |
| UAMS Jonesboro FMC | Jonesboro, Arkansas | United States | Not yet recruiting |
| UAMS Health Women's Center | Little Rock, Arkansas | United States | Recruiting |
| UAMS Springdale FMC | Springdale, Arkansas | United States | Recruiting |