Telehealth Multi-Component Optional Model (MOM) Study

Part of paid clinical trials in El Dorado, Arkansas.

Sponsor
University of Arkansas
Study ID
NCT06095960
Status
Recruiting
Apply to this trial

Conditions

  • Maternal Health

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 44 Years
Healthy Volunteers
Accepted

Interventions

  • 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.
  • 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.

Study Details

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.

Key Dates

Start date
Feb 12, 2024
Status verified
Feb 2026
Primary completion
Jan 30, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
1,500 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: 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.
  • Active Comparator: 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.

Primary Outcome Measure

Completion of post-partum 6-week comprehensive visit [ Time Frame: Baseline to 6 weeks post-partum ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
UAMS El Dorado FMCEl DoradoArkansas71730
Kenny Halloran
[email protected]
UAMS Fayetteville FMCFayettevilleArkansas72703
Kenny Halloran
[email protected]
UAMS Fort Smith FMCFort SmithArkansas72901
Kenny Halloran
[email protected]
UAMS Jonesboro FMCJonesboroArkansas72401
Kenny Halloran
[email protected]
UAMS Health Women's CenterLittle RockArkansas72205
Kenny Halloran
[email protected]
UAMS Springdale FMCSpringdaleArkansas72764
Kenny Halloran
[email protected]

Find similar trials in El Dorado, AR

By research site
UAMS El Dorado FMC· El Dorado, ARUAMS Fayetteville FMC· Fayetteville, ARUAMS Fort Smith FMC· Fort Smith, ARUAMS Jonesboro FMC· Jonesboro, ARUAMS Health Women's Center· Little Rock, ARUAMS Springdale FMC· Springdale, AR

Related Studies