Health and Wellness After Preterm Birth

Sponsor

Children's Hospital of Philadelphia (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05756634

Collaborator

University of Pennsylvania (Other), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH)

Enrollment

Location

Arms

33.1

Anticipated Duration (Months)

2.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Preterm Birth Health Care Utilization Tobacco Use Contraceptive Usage Depression Weight, Birth	Behavioral: Care Coordination after Preterm Birth (CCAPB)	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

94 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Health and Wellness After Preterm Birth: Randomized Controlled Trial of Enhanced Support After Preterm Birth

Anticipated Study Start Date :

Mar 1, 2023

Anticipated Primary Completion Date :

Jun 1, 2025

Anticipated Study Completion Date :

Dec 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CCAPB (intervention) Intervention participants will receive an intervention focused on health care navigation and motivational enhancement.	Behavioral: Care Coordination after Preterm Birth (CCAPB) For participants randomized to CCAPB, the care coordinator will follow a manulized 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.
Placebo Comparator: Usual Care Usual care participants will not receive the intervention.	Behavioral: Care Coordination after Preterm Birth (CCAPB) For participants randomized to CCAPB, the care coordinator will follow a manulized 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.

Arm

Intervention/Treatment

Experimental: CCAPB (intervention)

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

Behavioral: Care Coordination after Preterm Birth (CCAPB)

For participants randomized to CCAPB, the care coordinator will follow a manulized 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.

Placebo Comparator: Usual Care

Usual care participants will not receive the intervention.

Behavioral: Care Coordination after Preterm Birth (CCAPB)

Outcome Measures

Primary Outcome Measures

Acceptability of the CCAPB intervention [up to 6 months]
Investigators will use the Acceptability of Intervention Measure (modified) with a threshold of > 3 indicating acceptability.

Secondary Outcome Measures

Patient reported stress. [up to 6 months]
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 [up to 6 months]
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 [up to 6 months]
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 [up to 6 months]
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 [up to 6 months]
Completion of recommended postpartum care will be assessed by patient health record review.
Contraceptive Use [up to 6 months]
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 [up to 1 month]
Tobacco use will be assessed by asking participants "Have you smoked any cigarettes in the past 30 days?"
Multivitamin use [up to 6 months]
Multivitamin use will be assessed by asking participants "Are you currently taking a multivitamin?"
Autonomy Support [up to 6 months]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

14 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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
Infant born at the Hospital of the University of Pennsylvania' (HUP) or Pennsylvania Hospital

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