RECRUITING

Telehealth Multi-Component Optional Model (MOM) Study

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-02-12
Study Completion:2027-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06095960

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 44 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Pregnant women between 16-35 weeks gestation
  2. * Age 18-44 years
  3. * Ability to speak English, Spanish, or Marshallese
  4. * Participants may have either a vaginal birth or cesarean section birth
  1. * Type 1 diabetes on an insulin pump followed closely by endocrinology
  2. * Uncontrolled Type 2 diabetes
  3. * End stage renal disease followed closely by nephrology
  4. * ICU admission at any point during pregnancy or delivery hospitalization
  5. * Other maternal conditions requiring additional surgeries (i.e. cesarean hysterectomy or intrapartum or postpartum oophorectomy/appendectomy)
  6. * Incarceration
  7. * Mental disability limiting decision-making capacity
  8. * Uncontrolled chronic hypertension
  9. * HELLP syndrome during pregnancy
  10. * Sickle cell disease
  11. * Maternal heart condition or heart disease
  12. * Opioid use disorder
  13. * Lupus
  14. * Thrombophilia or blood clots
  15. * Need for blood transfusion during delivery hospitalization
  16. * Other maternal conditions or complications, known during pregnancy or delivery hospitalization, requiring prolonged hospitalization postpartum

Contacts and Locations

Study Contact

Brett Rowland, MA
CONTACT
4797138661
mbrowland@uams.edu
Kacie Simpson, BS
CONTACT
4797138661
klsimpson@uams.edu

Principal Investigator

Jennifer Callaghan-Koru, PhD
PRINCIPAL_INVESTIGATOR
University of Arkansas
Pearl McElfish, PhD
PRINCIPAL_INVESTIGATOR
University of Arkansas

Study Locations (Sites)

UAMS El Dorado FMC
El Dorado, Arkansas, 71730
United States
UAMS Fayetteville FMC
Fayetteville, Arkansas, 72703
United States
UAMS Fort Smith FMC
Fort Smith, Arkansas, 72901
United States
UAMS Jonesboro FMC
Jonesboro, Arkansas, 72401
United States
UAMS Health Women's Center
Little Rock, Arkansas, 72205
United States
UAMS Springdale FMC
Springdale, Arkansas, 72764
United States

Collaborators and Investigators

Sponsor: University of Arkansas

  • Jennifer Callaghan-Koru, PhD, PRINCIPAL_INVESTIGATOR, University of Arkansas
  • Pearl McElfish, PhD, PRINCIPAL_INVESTIGATOR, University of Arkansas

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-12
Study Completion Date2027-12-31

Study Record Updates

Study Start Date2024-02-12
Study Completion Date2027-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Maternal Health