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Behavioral Intervention

Telehealth MOM for Maternal Health

N/A

Recruiting

Led By Jennifer Callaghan-Koru, PhD

Research Sponsored by University of Arkansas

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 6 weeks post-partum

Awards & highlights

Study Summary

This trial aims to compare two different postpartum care models for diverse women: Telehealth Multicomponent Optimal Model (Telehealth MOM) and enhanced standard of care (ESoC). The goal is to see which model is more effective in providing comprehensive care and identifying and treating complications after childbirth. This study will help understand how to deliver postpartum care that meets the needs of different patient groups, including racial minorities and those living in rural areas.

Who is the study for?

This trial is for pregnant women aged 18-44, between 16-35 weeks gestation, who can communicate in English, Spanish, or Marshallese. It's not for those with certain severe medical conditions like uncontrolled diabetes, end-stage renal disease, ICU stays during pregnancy, or those with mental disabilities affecting decision-making.Check my eligibility

What is being tested?

The study compares two postpartum care models for diverse women: Telehealth MOM, which is a comprehensive telehealth approach, and an enhanced standard of care. It aims to find the best way to deliver postpartum care, especially for racial minorities and rural residents.See study design

What are the potential side effects?

Since this trial involves non-medical interventions (telehealth and standard care), traditional side effects associated with medications are not applicable. However, there may be indirect effects related to the adequacy and satisfaction with the care received.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 6 weeks post-partum

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 6 weeks post-partum

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 6 weeks post-partum for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Completion of post-partum 6-week comprehensive visit

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Telehealth MOMExperimental Treatment1 Intervention

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.

Group II: Enhanced Standard of CareActive Control1 Intervention

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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of ArkansasLead Sponsor

486 Previous Clinical Trials

148,853 Total Patients Enrolled

Patient-Centered Outcomes Research InstituteOTHER

551 Previous Clinical Trials

29,995,958 Total Patients Enrolled

1 Trials studying Maternal Health

30,000 Patients Enrolled for Maternal Health

Jennifer Callaghan-Koru, PhDPrincipal InvestigatorUniversity of Arkansas

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the research trial open to individuals who have reached or surpassed 75 years of age?

"This research project is open to individuals over 18 years of age but under the age of 44."

Answered by AI

Are there numerous facilities conducting this investigation within the city's limits?

"This clinical trial is being conducted at 6 sites, including UAMS Fayetteville FMC in Fayetteville, UAMS Fort Smith FMC in Fort Smith, and UAMS Jonesboro FMC in Jonesboro, among others."

Answered by AI

What specific criteria must individuals meet to be eligible for enrollment in this medical study?

"The trial aims to enroll 1500 females of reproductive age with maternal health concerns, aged 18 to 44. Essential requirements include carrying a pregnancy between 16 to 35 weeks, possessing an active smartphone, being proficient in English, Spanish, or Marshallese, and having the option of either vaginal or cesarean delivery."

Answered by AI

Is the ongoing medical study actively seeking participants at this time?

"Affirmative. Data accessible on clinicaltrials.gov indicates that this clinical trial is actively seeking participants. The trial was originally posted on February 12, 2024, and its latest update was on March 29, 2024. The study aims to recruit 1500 patients from six distinct sites."

Answered by AI

What is the current number of participants eligible for enrollment in this clinical research study?

"Indeed, the details available on clinicaltrials.gov indicate that this specific clinical trial is actively looking for eligible participants. The trial was initially posted on February 12th, 2024, and underwent its most recent revision on March 29th, 2024. The research team aims to recruit a total of 1500 patients distributed among 6 different sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Telehealth Multi-Component Optional Model (MOM) Study

2024. "Telehealth Multi-Component Optional Model (MOM) Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06095960.