- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04149002
Improving the Clinical Encounter to Enhance Delivery of an Individualized Prematurity Prevention Plan
Improving the Clinical Encounter to Enhance Delivery of an Individualized Prematurity Prevention Plan (IP3) - The IMPaCT-IP3 Study
Study Overview
Status
Conditions
Detailed Description
The study team will pilot test the intervention via a pilot randomized controlled trial. 60 pregnant NHB women will be recruited who have a history of singleton preterm birth and are currently pregnant with a singleton gestation. Consenting participants will be randomized to the intervention or an active control. The intervention includes: 1) an informational narrated powerpoint presentation that reviews the logistical details of the IP3, 2) structured encouragement via text messages and 3) employment law education sheet. The powerpoints will also be available for review on our you-tube channel for intervention patients. The active control arm includes: 1) a narrated powerpoint describing the Duke Prematurity Prevention Program and 2) text messages with general pregnancy information (i.e. it is safe to take Tylenol in pregnancy). At study intake, we will collect demographic data (age, self-described race, pregnancy history, social history, pregnancy-related anxiety scale, interpersonal processes of care and maternal social support index.
The team will collect feedback on the intervention based on an intake questionnaire and an exit interview.
Information will also be collected on adherence to the IP3 based on review of the participant's medical record. The primary aim of the study is to evaluation feasibility and acceptability. These endpoints will be measured via enrollment and participant feedback during the exit interview.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
North Carolina
-
Durham, North Carolina, United States, 27705
- Duke University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- self described race as Non-Hispanic Black
- history of prior singleton preterm delivery (before 37 weeks gestation)
- current singleton gestation
Exclusion Criteria:
- women with anomalous fetuses
- age below 18]
- non-English speaking
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
OTHER: Intervention Arm: Weekly IP3 text messages
|
Subjects will be provided with a pre and post intervention survey, in addition to a narrated Powerpoint presentation focusing on the logistics of their IP3.
Subjects will also receive weekly automated text messages to encourage adherence to the need for their IP3.
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ACTIVE_COMPARATOR: Control Arm: General pregnancy text messages
|
Subjects will be given pre and post pre questionnaires, in addition to a narrated Powerpoint presentation about the Clinic.
Subjects will also be sent weekly text messages with general pregnancy information.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility as Measured by Number of Recruited Eligible Patients Enrolled
Time Frame: study duration (approximately 14 months)
|
Enrollment target of 30% of eligible patients recruited.
|
study duration (approximately 14 months)
|
Acceptability as Measured by Number of Participants Who Completed the Study
Time Frame: study duration (approximately 14 months)
|
Completion target of 80% participants retained in study protocol.
|
study duration (approximately 14 months)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
IP3 Adherence as Measured by Number of Participants With Patient and EMR (Electronic Medical Record) Report of Medication Compliance
Time Frame: approximately 1 year
|
approximately 1 year
|
|
Pregnancy Specific Anxiety (PSA)
Time Frame: baseline, 28 weeks
|
Pregnancy specific anxiety is a 4-question scale.
Each question can be answered on a range of 1 to 5. Scores were averaged to produce one mean PSA score ranging from 1-5.
Higher scores are negative and denote increased anxiety.
|
baseline, 28 weeks
|
Interpersonal Process of Care (IPC-18) at Protocol Completion - Communication Domain
Time Frame: protocol completion (approximately 1 year)
|
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 IPC items use an identical set of response options: 1='never'; 2='rarely'; 3='sometimes'; 4='usually'; 5='always.'
Item responses are averaged, not summed; thus, scores have a possible range of 1-5.
All scales are scored so that higher scores indicate higher frequency of the labeled interpersonal process: Lack of clarity (higher scores are negative), Elicits concern (higher scores are positive), and Explain results (higher scores are positive).
|
protocol completion (approximately 1 year)
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Interpersonal Process of Care (IPC-18) at Protocol Completion - Decision Making Domain
Time Frame: protocol completion (approximately 1 year)
|
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 IPC items use an identical set of response options: 1='never'; 2='rarely'; 3='sometimes'; 4='usually'; 5='always.'
Item responses are averaged, not summed; thus, scores have a possible range of 1-5.
All scales are scored so that higher scores indicate higher frequency of the labeled interpersonal process: Decision Making (higher scores are positive, denoting more collaborative decision making between the clinician and patient).
|
protocol completion (approximately 1 year)
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Interpersonal Process of Care (IPC-18) at Protocol Completion - Interpersonal Style Domain
Time Frame: protocol completion (approximately 1 year)
|
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 IPC items use an identical set of response options: 1='never'; 2='rarely'; 3='sometimes'; 4='usually'; 5='always.'
Item responses are averaged, not summed; thus, scores have a possible range of 1-5.
All scales are scored so that higher scores indicate higher frequency of the labeled interpersonal process: Emotional support (higher scores are positive), Discrimination due to race/ethnicity (higher scores are negative), Disrespectful to office staff (higher scores are negative).
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protocol completion (approximately 1 year)
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Change in Maternal Social Support Scale (MSSS)
Time Frame: baseline to protocol completion (approximately 1 year)
|
The MSSS is a six-question scale that quantifies a pregnant woman's social support.
Social factors (lack of family support, low friendship network, lack of help from spouse/partner, conflict with spouse/partner, feeling controlled by spouse/partner, and feeling unloved by spouse/partner) are combined in a 6-item self-report 5-point Likert scale.
The total possible score for the scale is between 6 and 30, with higher scores indicating increased support.
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baseline to protocol completion (approximately 1 year)
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Gestational Age at Delivery in Weeks
Time Frame: approximately 40 weeks
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approximately 40 weeks
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Birth Weight in Grams
Time Frame: approximately 40 weeks
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approximately 40 weeks
|
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Number of Neonates Admitted to the Newborn Intensive Care Unit (NICU)
Time Frame: approximately 40 weeks
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approximately 40 weeks
|
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Length of Delivery Hospital Admission in Days
Time Frame: approximately 40 weeks
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approximately 40 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00103922
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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