Telehealth Multi-Component Optional Model (MOM) Study

Maternal Health Clinical Trial

Official title:

Comparative Evaluation of Telehealth Multi-Component Optional Model (MOM) of Postpartum Care Among Rural, Low-income, and Diverse Women

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06095960
• Other study ID #: 276311
• Status: Recruiting
• Phase: N/A
• Start date: February 12, 2024
• Est. completion date: December 31, 2027

Study information

• Verified date: March 2024
• Source: University of Arkansas
• Contact: Brett Rowland, MA
• Phone: 4797138661
• Email: mbrowland[@]uams.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: December 31, 2027
• Est. primary completion date: January 30, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 44 Years

Eligibility

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

Related Conditions & MeSH terms

• Maternal Health

Intervention

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

Other:
• Enhanced Standard of Care
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.

Locations

Country	Name	City	State
United States	UAMS El Dorado FMC	El Dorado	Arkansas
United States	UAMS Fayetteville FMC	Fayetteville	Arkansas
United States	UAMS Fort Smith FMC	Fort Smith	Arkansas
United States	UAMS Jonesboro FMC	Jonesboro	Arkansas
United States	UAMS Health Women's Center	Little Rock	Arkansas
United States	UAMS Springdale FMC	Springdale	Arkansas

Sponsors (2)

Lead Sponsor	Collaborator
University of Arkansas	Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Completion of post-partum 6-week comprehensive visit	Binary measure (yes/no) of visit completion	Baseline to 6 weeks post-partum