Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group Social Support Meetings and Facebook Group | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Facebook discussions and Virtual group meetings | Behavioral | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Eligible Participants Who Are Successfully Recruited and Attend at Least One Group Session | up to 12 weeks after delivery (approximately 1 year) | |
| Number of Sessions Attended by Each Participant | As a measure of effectiveness | up to 12 weeks after delivery (approximately 1 year) |
| Implementation as Measured by the Number of Sessions Including Each Topic | up to 12 weeks after delivery (approximately 1 year) | |
| Engagement as Measured by Number of Participants Who Attended More Than One Session | Intervention sustainability based on continued engagement from the participants | up to 12 weeks after delivery (approximately 1 year) |
| Engagement as Measured by Number of Participants Who Completed PSA (Pregnancy-specific Anxiety), IPC-18 (Interpersonal Processes of Care), MSSS (Maternal Social Support Scale), and CSQ-9 (Client Satisfaction Questionnaire) at All Time Points | Intervention sustainability based on continued engagement from the participants | up to 12 weeks after delivery (approximately 1 year) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Sarahn Wheeler, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University | Durham | North Carolina | 27705 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36636112 | Derived | Wheeler SM, Massengale KEC, Fitzgerald TA, Truong T, Ostbye T, Corneli A, Swamy GK. IMPaCT: A Pilot Randomized Trial of an Intervention to Reduce Preterm Birth Among Non-Hispanic Black Patients at High Risk. Health Equity. 2022 Dec 19;6(1):922-932. doi: 10.1089/heq.2022.0089. eCollection 2022. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Group Social Support Meetings and Facebook Group | 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. Facebook discussions and Virtual group meetings: 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Participants who completed the study.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Group Social Support Meetings and Facebook Group | 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. Facebook discussions and Virtual group meetings: 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Eligible Participants Who Are Successfully Recruited and Attend at Least One Group Session | Posted | Count of Participants | Participants | up to 12 weeks after delivery (approximately 1 year) |
|
|
Up to 12 weeks after delivery (approximately 1 year)
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group Social Support Meetings and Facebook Group | 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. Facebook discussions and Virtual group meetings: 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| IUFD (Intrauterine Fetal Demise) | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment | Unrelated to study. |
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sarahn Wheeler | Duke University | 919-668-5462 | sarahn.wheeler@duke.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 1, 2021 | Apr 9, 2024 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 17, 2023 | Apr 9, 2024 | SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 17, 2021 | Oct 3, 2022 | ICF_000.pdf |
Not provided
| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
Not provided
Not provided
Intervention Arm
Not provided
Not provided
Not provided
Not provided
| at intake |
| 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. On a Likert scale of 1 to 5, higher scores indicate greater anxiety. | At intake and at gestational age 20-28 weeks |
| 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). On a Likert scale of 1 to 5, higher scores indicate more of the item being measured. | at intake |
| 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). On a Likert scale of 1 to 5, higher scores indicate more of the item being measured. | Gestational age 20-28 weeks |
| 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). On a Likert scale of 1 to 5, higher scores indicate more of the item being measured. | Gestational age >= 30 weeks |
| 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. On a Likert scale of 1 to 5, higher scores indicate greater social support. | At intake, gestational age 20-28 weeks, and gestational age >=30 weeks |
| Number of Participants Who Were Adherent to the IP3 Plan | Adherence to the IP3 based on both participant report and EHR chart review; dichotomized as adherent or not adherent. | Post delivery (up to approximately 40 weeks) |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Participants |
|
|
| Primary | Number of Sessions Attended by Each Participant | As a measure of effectiveness | Posted | Mean | Standard Deviation | sessions | up to 12 weeks after delivery (approximately 1 year) |
|
|
|
| Primary | Implementation as Measured by the Number of Sessions Including Each Topic | Posted | Count of Units | Sessions | up to 12 weeks after delivery (approximately 1 year) | Sessions | Sessions |
|
|
|
| Primary | Engagement as Measured by Number of Participants Who Attended More Than One Session | Intervention sustainability based on continued engagement from the participants | Posted | Count of Participants | Participants | up to 12 weeks after delivery (approximately 1 year) |
|
|
|
| Primary | Engagement as Measured by Number of Participants Who Completed PSA (Pregnancy-specific Anxiety), IPC-18 (Interpersonal Processes of Care), MSSS (Maternal Social Support Scale), and CSQ-9 (Client Satisfaction Questionnaire) at All Time Points | Intervention sustainability based on continued engagement from the participants | Posted | Count of Participants | Participants | up to 12 weeks after delivery (approximately 1 year) |
|
|
|
| Secondary | 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 | Participants who received each question per their IP3 plan. | Posted | Mean | Standard Deviation | score on a scale | at intake |
|
|
|
| Secondary | 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. On a Likert scale of 1 to 5, higher scores indicate greater anxiety. | Posted | Mean | Standard Deviation | score on a scale | At intake and at gestational age 20-28 weeks |
|
|
|
| Secondary | 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). On a Likert scale of 1 to 5, higher scores indicate more of the item being measured. | Posted | Mean | Standard Deviation | score on a scale | at intake |
|
|
|
| Secondary | 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). On a Likert scale of 1 to 5, higher scores indicate more of the item being measured. | Posted | Mean | Standard Deviation | score on a scale | Gestational age 20-28 weeks |
|
|
|
| Secondary | 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). On a Likert scale of 1 to 5, higher scores indicate more of the item being measured. | Posted | Mean | Standard Deviation | score on a scale | Gestational age >= 30 weeks |
|
|
|
| Secondary | 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. On a Likert scale of 1 to 5, higher scores indicate greater social support. | Posted | Mean | Standard Deviation | score on a scale | At intake, gestational age 20-28 weeks, and gestational age >=30 weeks |
|
|
|
| Secondary | Number of Participants Who Were Adherent to the IP3 Plan | Adherence to the IP3 based on both participant report and EHR chart review; dichotomized as adherent or not adherent. | Participants to which the measure was relevant. | Posted | Count of Participants | Participants | Post delivery (up to approximately 40 weeks) |
|
|
|
| 0 |
| 31 |
| 1 |
| 31 |
| 0 |
| 31 |
|
Not provided
Not provided
Not provided
| D000091642 | Urogenital Diseases |
| Title | Measurements |
|---|---|
|
| Preterm Labor - Warning Signs / Symptoms |
|
| The Labor Process |
|
| Pregnancy Progression |
|
| Late Pregnancy Warning Signs |
|
| Reunion |
|
|
| Low dose aspirin |
|
|
| Lifestyle modification |
|
|
| Title | Measurements |
|---|---|
|
| Decided together |
|
| Emotional support, compassion |
|
| Discriminated due to race/ethnicity |
|
| Disrespectful office staff |
|
| Title | Measurements |
|---|---|
|
| Decided together |
|
| Emotional support, compassion |
|
| Discriminated due to race/ethnicity |
|
| Disrespectful office staff |
|
| Title | Measurements |
|---|---|
|
| Decided together |
|
| Emotional support, compassion |
|
| Discriminated due to race/ethnicity |
|
| Disrespectful office staff |
|
| Title | Measurements |
|---|---|
|
|
| 17-P |
|
|
| Progesterone |
|
|
| Cerclage |
|
|
| Serial cervix length |
|
|
| Low dose aspirin |
|
|