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EngagINg the COmmunity to Reduce Preterm Birth Via Adherence To an Individualized Prematurity Prevention Plan

Primary Purpose

Preterm Birth

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Facebook discussions and Virtual group meetings
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Preterm Birth

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • self describe race as Non-hispanic black
  • history of prior singleton preterm delivery (before 37 weeks gestation
  • current singleton gestation, with Individualized Prematurity Prevention (IP3) plan.

Exclusion Criteria:

  • women with anomalous fetuses
  • age below 18 years
  • non-English speaking

Sites / Locations

  • Duke University

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Group Social Support Meetings and Facebook Group

Arm Description

Facebook group where community doulas will be providing information on various pregnancy and support topics in addition to 8 possible group Zoom meetings that will include pregnancy-related/reflection topics.

Outcomes

Primary Outcome Measures

Reach or Participation Rate
Percent of eligible participants who are successfully recruited and attend at least one group session
Effectiveness
Retention rate in the intervention measured by the number of sessions each participant
Implementation
Fidelity to the intervention protocol by observer at each group session recording the topics
Maintenance
Intervention sustainability based on continued engagement from the participants

Secondary Outcome Measures

IP3 knowledge questionnaire
Questionnaire includes approximately four questions aimed to evaluate a participants knowledge about the details of their IP3 plan. Participants will only receive questions that pertain to their specific IP3. They will be given the answers immediately following the assessment. Understanding of preterm birth and precautions; higher scores better, each questionnaire ranges from 0 to 5 questions correct
Pregnancy-specific anxiety (PSA)
The PSA is a validated 13-item tool used to assess anxiety specific to pregnancy this tool has been correlated with preterm birth outcome. higher scores are negative, four questions answered on a 1 to 5 Likert scare
Interpersonal Processes of Care (IPC)
The IPC is an 18-question questionnaire that asks participants about their experience with receiving care within a specific clinic (in this case the Duke Perinatal Durham Clinic). All domains are measured 1 to 5 on a Likert scale
Maternal Social Support Scale (MSSS)
The MSSS is a six-question scale that quantifies a pregnant women's social support as low, medium or adequate. Higher scores better - 1 to 5 Likert scale
IP3 Adherence Data
We will gather data on adherence to the IP3 based on both participant report and EHR chart review. Higher is better, dichotomized as adherent or not adherent
Tobacco Use PRAMS Questionnaire
A single question regarding tobacco use

Full Information

First Posted
June 14, 2021
Last Updated
March 6, 2023
Sponsor
Duke University
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1. Study Identification

Unique Protocol Identification Number
NCT04933812
Brief Title
EngagINg the COmmunity to Reduce Preterm Birth Via Adherence To an Individualized Prematurity Prevention Plan
Official Title
EngagINg the COmmunity to Reduce Preterm Birth Via Adherence To an Individualized Prematurity Prevention Plan (INCORPorATe IP3)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
June 21, 2021 (Actual)
Primary Completion Date
October 14, 2022 (Actual)
Study Completion Date
October 14, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine if INCORPorATe IP3 is feasible prior to a larger trial focused on determining efficacy. Feasibility will be measured using the RE-AIM framework4: Reach or Participation (Primary Outcome): (a) percent of eligible participants who are successfully recruited and attend at least one group session; Effectiveness: retention rate in the intervention; Implementation: fidelity to the intervention protocol; Maintenance: intervention sustainability based on continued engagement from the participants.
Detailed Description
Non-Hispanic black (NHB) women are 49% more likely to experience a preterm birth (PTB), delivery before 37 weeks. PTB is associated with increased risk of poor short and long-term neonatal outcomes. PTB can occur in multiple clinical scenarios including spontaneous PTB (e.g. preterm labor, preterm pre-labor rupture of membranes) and medically induced preterm labor (e.g. preeclampsia). Women with a history of PTB are at 1.5 - 2 fold increased risk for future PTB. There are medical therapies than can reduce the risk of recurrent PTB specific to the presumed etiology of the prior PTB. Thus, women with a history of a prior PTB who receive care with Duke Maternal Fetal Medicine (MFM) receive and Individualized Prematurity Prevention Plan (IP3) to reduce their risk of recurrent PTB. The IP3 plans are often labor intensive with requirements ranging from daily medications, weekly clinic visits, painful injections or invasive ultrasounds. Given the increased rate so of PTB among NHB women and some suggestion of decreased adherence in this population1, we previously conducted qualitative studies with NHB women to uncover patient perceived barriers to IP3 adherence2,3. These studies revealed that NHB women with prior preterm birth felt that stress and lack of support were key barriers to preterm birth prevention adherence. Stress and limited support made women feel isolated from their peers and community. Based on these data we worked with a stakeholder group to develop a patient-centered, community-involved intervention that will increased adherence to an individualized prematurity prevention plan using community-level social supports. The resulting invention titled, EngagINg the COmmunity to Reduce Preterm Birth via Adherence To an Individualized Prematurity Prevention Plan (INCORPorATe IP3) includes community doula led group social support.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Birth

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Intervention Arm
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group Social Support Meetings and Facebook Group
Arm Type
Other
Arm Description
Facebook group where community doulas will be providing information on various pregnancy and support topics in addition to 8 possible group Zoom meetings that will include pregnancy-related/reflection topics.
Intervention Type
Behavioral
Intervention Name(s)
Facebook discussions and Virtual group meetings
Intervention Description
Participants must join a study-specific private Facebook group and engage in discussion. Once the discussion is complete, participants have the opportunity to join virtual group sessions via Zoom
Primary Outcome Measure Information:
Title
Reach or Participation Rate
Description
Percent of eligible participants who are successfully recruited and attend at least one group session
Time Frame
1 year
Title
Effectiveness
Description
Retention rate in the intervention measured by the number of sessions each participant
Time Frame
1 year
Title
Implementation
Description
Fidelity to the intervention protocol by observer at each group session recording the topics
Time Frame
1 year
Title
Maintenance
Description
Intervention sustainability based on continued engagement from the participants
Time Frame
1 year
Secondary Outcome Measure Information:
Title
IP3 knowledge questionnaire
Description
Questionnaire includes approximately four questions aimed to evaluate a participants knowledge about the details of their IP3 plan. Participants will only receive questions that pertain to their specific IP3. They will be given the answers immediately following the assessment. Understanding of preterm birth and precautions; higher scores better, each questionnaire ranges from 0 to 5 questions correct
Time Frame
monthly until delivery
Title
Pregnancy-specific anxiety (PSA)
Description
The PSA is a validated 13-item tool used to assess anxiety specific to pregnancy this tool has been correlated with preterm birth outcome. higher scores are negative, four questions answered on a 1 to 5 Likert scare
Time Frame
monthly until delivery
Title
Interpersonal Processes of Care (IPC)
Description
The IPC is an 18-question questionnaire that asks participants about their experience with receiving care within a specific clinic (in this case the Duke Perinatal Durham Clinic). All domains are measured 1 to 5 on a Likert scale
Time Frame
monthly until delivery
Title
Maternal Social Support Scale (MSSS)
Description
The MSSS is a six-question scale that quantifies a pregnant women's social support as low, medium or adequate. Higher scores better - 1 to 5 Likert scale
Time Frame
monthly until delivery
Title
IP3 Adherence Data
Description
We will gather data on adherence to the IP3 based on both participant report and EHR chart review. Higher is better, dichotomized as adherent or not adherent
Time Frame
monthly until delivery
Title
Tobacco Use PRAMS Questionnaire
Description
A single question regarding tobacco use
Time Frame
monthly until delivery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: self describe race as Non-hispanic black history of prior singleton preterm delivery (before 37 weeks gestation current singleton gestation, with Individualized Prematurity Prevention (IP3) plan. Exclusion Criteria: women with anomalous fetuses age below 18 years non-English speaking
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarahn Wheeler, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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EngagINg the COmmunity to Reduce Preterm Birth Via Adherence To an Individualized Prematurity Prevention Plan

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