Telehealth Multi-Component Optional Model (MOM) Study
ConditionMaternal Health
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-44
SponsorUniversity of Arkansas
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Telehealth MOM
BehavioralPatients 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 interventionPatients 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.
Treatment groups
1,500 Participants
are divided into 2 treatment groupsGroup A: Telehealth MOMExperimental treatment 1 intervention
Group B: Enhanced Standard of CareActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Completion of post-partum 6-week comprehensive visit
Binary measure (yes/no) of visit completion
Time frame
Baseline to 6 weeks post-partumSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Arkansas
Lead sponsor
Patient-Centered Outcomes Research Institute
Collaborator
Source ClinicalTrials.gov