Prevent Maternal Mortality Using Mobile Technology

NCT05339867 | Unknown DMC

• 1 other identifier: STUDY00003016
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 2

Brief Summary

Black women who reside in a rural area are at highest risk for maternal morbidity and mortality due to a combination of social and structural causes. The postpartum period is the most critical yet most neglected phase for preventing suboptimal or fatal maternal health outcomes. The goal of this project is to use a mobile app to provide personalized support and improve the lives of women during the early postpartum period. The information the study team gathers will help educate women and all who support them about the need to seek postpartum care and the impact postpartum care can have on pregnancy-related complications. Participation in this research requires taking part in a focus group discussion which will allow participants to share or the person that supports the participant's story and experience with postpartum complications and willingness to use and desired features of a postpartum mobile app.

Conditions

Post-Partum

Keywords

Postpartum Black mothers

Outcome Measures

Primary Outcomes (1)

• Number of completion of postpartum healthcare visit ( Healthcare Resource utilization)

  Around 50% of the women receive a postpartum visit within that time. The study aims to increase postpartum visit attendance by 25% for a goal of 75%. The completion of a visit and other clinical outcomes will be confirmed by a medical chart review. This will be measured as number of participants completing the post partum healthcare visit.

  At weeks 4 to 6 postpartum

Secondary Outcomes (18)

• Changes in Current Life Situation

  Baseline, month 3, month 6 and month 12

• Changes in Women Sexual Health History

  Baseline, month 3, month 6 and month 12

• Changes in Blood pressure

  Baseline, month 3, month 6 and month 12

• Changes in Health related quality of life questionnaires (HRQoL)

  Baseline, month 3, month 6 and month 12

• Changes in Hair cortisol levels

  Baseline and 3 months

Study Arms (2)

Mothers following Standard of Care

NO INTERVENTION

Participants randomized to this group will receive standard of Care for Postpartum. The standard of care control condition will be what women would typically get at hospital discharge (typically an Electronic Medical Record (EMR) generated document; a non-standardized, generalized brief review of how to care for self and the baby).

Mother Using PM3 Intervention

EXPERIMENTAL

Participants in this group will be using the PM3 intervention. PM3 is a maternal mortality prevention and optimal reproductive health promotion mobile app created based on formative work with Black women to ultimately increase postpartum comorbidity self-management, promote timely provider notification of postpartum-related complications, and ensure access to social support and community resources.

Behavioral: Prevent Maternal Mortality using Mobile technology (PM3)

Interventions

Prevent Maternal Mortality using Mobile technology (PM3) BEHAVIORAL

PM3: The app will include: 1. integrated self-management and tailored health messaging feature 2. support center based on social support gaps which will also provide a centralized place for identifying healthcare providers and facilities 3. multimedia resource kit comprised of videos, current events, news feeds, podcasts, and support groups related to women's postpartum health and community resources 4. a feature that will update women on maternal and reproductive health policies that impact women.

Mother Using PM3 Intervention

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Participants self -identify as female
• Participants must self-identify as African American/Black
• Aged 18-45 years
• Can speak or read English
• Participants must be able to give consent.
• Own a smart phone
• Reside in or near Albany, LaGrange, or Waynesboro (within a 40 mile radius)
• Be in third trimester or recently had a baby (≤4 weeks postpartum)
• Can be contacted by phone or email after hospital discharge.

You may not qualify if:

• Women will be excluded if they have known unavailability to follow-up
• An active severe mental health condition, or developmental disability precluding informed consent

Sponsors & Collaborators

• Emory University: lead

Study Sites (2)

Morehouse School of Medicine

Atlanta, Georgia, 30310, United States

RECRUITING

Emory University, Nell Hodgson Woodruff School of Nursing

Atlanta, Georgia, 30322, United States

RECRUITING

Study Officials

• Natalie Hernandez, PhD

  Assistant Professor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rasheeta Chandler, PhD

CONTACT

404-727-8164; r.d.chandler@emory.edu

Rashidat Ayantunji, MPH

CONTACT

rayantu@emory.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Only the participants will be blinded to their assigned group. Immediately after participants have completed their baseline assessment, study staff will open a sealed envelope to identify the participants' group assignment.
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 4, 2022
• First Posted: April 21, 2022
• Study Start: March 22, 2022
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2023
• Last Updated: April 21, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)