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Health and Wellness After Preterm Birth

Primary Purpose

Preterm Birth, Health Care Utilization, Tobacco Use

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Care Coordination after Preterm Birth (CCAPB)
Sponsored by
Children's Hospital of Philadelphia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Preterm Birth focused on measuring Preconception Care, Interconception care, Postpartum care, Preventive health care, Care coordination, Motivational Interviewing

Eligibility Criteria

14 Years - 45 Years (Child, Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: Female Age 14 - 45 History of preterm birth (< 34 weeks gestational age or 34 - 36 weeks with identifiable risk factors for recurrent preterm birth which may include low preventive care utilization, tobacco use, obesity, depression or anxiety, or history of unmet contraceptive needs) Intention to seek pediatric care at one of two pediatric primary care sites Medicaid insurance Exclusion Criteria: History of sterilization procedure. Plan to move away from the area or transfer pediatric primary care within six months of enrollment. Limited English proficiency. History of organ failure or malignancies.

Sites / Locations

  • Hospital of the University of PennsylvaniaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

CCAPB (intervention)

Usual Care

Arm Description

Intervention participants will receive an intervention focused on health care navigation and motivational enhancement.

Usual care participants will not receive the intervention.

Outcomes

Primary Outcome Measures

Acceptability of the CCAPB intervention
Investigators will use the Acceptability of Intervention Measure (modified) with a threshold of > 3 indicating acceptability.

Secondary Outcome Measures

Patient reported stress.
Stress will be measured by the validated Perceived Stress Scale (PSS).The Perceived Stress Scale (PSS) is the most widely used psychological instrument for measuring the perception of stress. It is a measure of the degree to which situations in one's life are appraised as stressful.Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress.
Sleep-related impairment
Sleep-related impairment will be measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep-Related Impairment - Short Form 8a. The Sleep-Related Impairment instrument is a self-reported tool used to document perceived overall sleep-related impairment (or sleep-wake function) over the past seven days. The PROMIS method of scoring uses responses to each item for each participant. For most PROMIS instruments, a score of 50 is the average for the United States general population with a standard deviation of 10 because calibration testing was performed on a large sample of the general population.
Depression symptoms
Depression symptoms will be measured by the Edinburgh Postnatal Depression Scale (EPDS). The 10-question Edinburgh Postnatal Depression Scale (EPDS) is used to identify patients at risk for perinatal depression. Mothers who score above 13 are likely to be suffering from a depressive illness of varying severity.
Autonomous motivation
Autonomous motivation will be measured using the Autonomous Motivation and External Regulation scales of the Treatment Self-Regulation Questionnaire (10 items, range 7 - 70, Cronbach alpha 0.90). This is a self administered questionnaire with a higher score indicating higher emotion regulation strategy.
Completion of recommended postpartum care
Completion of recommended postpartum care will be assessed by patient health record review.
Contraceptive Use
Contraceptive Use will be measured using an item from the self administered PRAMS questionnaire. Are you or your husband or partner doing anything now to keep from getting pregnant? No / Yes (if Yes proceed to next) What kind of birth control are you or your husband using now to keep from getting pregnant? PRAMS is an ongoing, site-specific, population-based surveillance system designed to identify groups of women and infants at high risk for health problems, to monitor changes in health status, and to measure progress towards goals in improving the health of mothers and infants.
Tobacco use
Tobacco use will be assessed by asking participants "Have you smoked any cigarettes in the past 30 days?"
Multivitamin use
Multivitamin use will be assessed by asking participants "Are you currently taking a multivitamin?"
Autonomy Support
Autonomy support will be measured with the self regulated short form of the Health Care Climate Questionnaire (6 items, range 6 - 42, Cronbach alpha 0.82). Scores on the short form 6-item version are calculated by averaging the individual item scores. Higher average scores represent a higher level of perceived autonomy support.

Full Information

First Posted
February 20, 2023
Last Updated
August 3, 2023
Sponsor
Children's Hospital of Philadelphia
Collaborators
University of Pennsylvania, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT05756634
Brief Title
Health and Wellness After Preterm Birth
Official Title
Health and Wellness After Preterm Birth: Randomized Controlled Trial of Enhanced Support After Preterm Birth
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 17, 2023 (Actual)
Primary Completion Date
September 1, 2025 (Anticipated)
Study Completion Date
March 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital of Philadelphia
Collaborators
University of Pennsylvania, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

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
This study continues an adaptation of the behavioral intervention Care Coordination After Preterm Birth (CCAPB). This is a pragmatic pilot randomized controlled feasibility trial of CCAPB with baseline and post-intervention assessments.
Detailed Description
Interventionists will be trained in care coordination strategies and Motivational Interviewing (MI) techniques. Following training, investigators will enroll eligible women from a postpartum unit at a single hospital, or within 4 weeks of birth.The primary outcome of this study is acceptability and feasibility of the intervention and study procedures as measured by the Acceptability of Intervention Measure, participant completion of study data collection, and interventionist completion of planned intervention modules.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Birth, Health Care Utilization, Tobacco Use, Contraceptive Usage, Depression, Weight, Birth
Keywords
Preconception Care, Interconception care, Postpartum care, Preventive health care, Care coordination, Motivational Interviewing

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
94 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CCAPB (intervention)
Arm Type
Experimental
Arm Description
Intervention participants will receive an intervention focused on health care navigation and motivational enhancement.
Arm Title
Usual Care
Arm Type
Placebo Comparator
Arm Description
Usual care participants will not receive the intervention.
Intervention Type
Behavioral
Intervention Name(s)
Care Coordination after Preterm Birth (CCAPB)
Intervention Description
For participants randomized to CCAPB, the care coordinator will follow a manualized intervention to support care planning, health care access, and wellbeing. Contact with participants will be initiated as soon as possible after enrollment, and will continue until six months after enrollment.
Primary Outcome Measure Information:
Title
Acceptability of the CCAPB intervention
Description
Investigators will use the Acceptability of Intervention Measure (modified) with a threshold of > 3 indicating acceptability.
Time Frame
up to 6 months
Secondary Outcome Measure Information:
Title
Patient reported stress.
Description
Stress will be measured by the validated Perceived Stress Scale (PSS).The Perceived Stress Scale (PSS) is the most widely used psychological instrument for measuring the perception of stress. It is a measure of the degree to which situations in one's life are appraised as stressful.Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress.
Time Frame
up to 6 months
Title
Sleep-related impairment
Description
Sleep-related impairment will be measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep-Related Impairment - Short Form 8a. The Sleep-Related Impairment instrument is a self-reported tool used to document perceived overall sleep-related impairment (or sleep-wake function) over the past seven days. The PROMIS method of scoring uses responses to each item for each participant. For most PROMIS instruments, a score of 50 is the average for the United States general population with a standard deviation of 10 because calibration testing was performed on a large sample of the general population.
Time Frame
up to 6 months
Title
Depression symptoms
Description
Depression symptoms will be measured by the Edinburgh Postnatal Depression Scale (EPDS). The 10-question Edinburgh Postnatal Depression Scale (EPDS) is used to identify patients at risk for perinatal depression. Mothers who score above 13 are likely to be suffering from a depressive illness of varying severity.
Time Frame
up to 6 months
Title
Autonomous motivation
Description
Autonomous motivation will be measured using the Autonomous Motivation and External Regulation scales of the Treatment Self-Regulation Questionnaire (10 items, range 7 - 70, Cronbach alpha 0.90). This is a self administered questionnaire with a higher score indicating higher emotion regulation strategy.
Time Frame
up to 6 months
Title
Completion of recommended postpartum care
Description
Completion of recommended postpartum care will be assessed by patient health record review.
Time Frame
up to 6 months
Title
Contraceptive Use
Description
Contraceptive Use will be measured using an item from the self administered PRAMS questionnaire. Are you or your husband or partner doing anything now to keep from getting pregnant? No / Yes (if Yes proceed to next) What kind of birth control are you or your husband using now to keep from getting pregnant? PRAMS is an ongoing, site-specific, population-based surveillance system designed to identify groups of women and infants at high risk for health problems, to monitor changes in health status, and to measure progress towards goals in improving the health of mothers and infants.
Time Frame
up to 6 months
Title
Tobacco use
Description
Tobacco use will be assessed by asking participants "Have you smoked any cigarettes in the past 30 days?"
Time Frame
up to 1 month
Title
Multivitamin use
Description
Multivitamin use will be assessed by asking participants "Are you currently taking a multivitamin?"
Time Frame
up to 6 months
Title
Autonomy Support
Description
Autonomy support will be measured with the self regulated short form of the Health Care Climate Questionnaire (6 items, range 6 - 42, Cronbach alpha 0.82). Scores on the short form 6-item version are calculated by averaging the individual item scores. Higher average scores represent a higher level of perceived autonomy support.
Time Frame
up to 6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Female Age 14 - 45 History of preterm birth (< 34 weeks gestational age or 34 - 36 weeks with identifiable risk factors for recurrent preterm birth which may include low preventive care utilization, tobacco use, obesity, depression or anxiety, or history of unmet contraceptive needs) Intention to seek pediatric care at one of two pediatric primary care sites Medicaid insurance Exclusion Criteria: History of sterilization procedure. Plan to move away from the area or transfer pediatric primary care within six months of enrollment. Limited English proficiency. History of organ failure or malignancies.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emily Gregory, MD, MPH
Phone
2154193122
Email
gregorye@chop.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Adya Maddox, MPH
Email
maddoxa1@chop.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emily Gregory, MD, MPH
Organizational Affiliation
Children's Hospital of Philadelphia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Meaghan Mccabe
Email
meaghan.mccabe@pennmedicine.upenn.edu

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Data will be used to refine the protocol for further testing. There are no plans to share individual participant data.

Learn more about this trial

Health and Wellness After Preterm Birth

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