Health and Wellness After Preterm Birth
- Conditions
- Tobacco UseWeight, BirthDepressionPreterm BirthHealth Care UtilizationContraceptive Usage
- Interventions
- Behavioral: Care Coordination after Preterm Birth (CCAPB)
- Registration Number
- NCT05756634
- Lead Sponsor
- Children's Hospital of Philadelphia
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 96
- 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 including: low preventive care utilization, tobacco use, obesity, depression or anxiety, history of unmet contraceptive needs, chronic or pregnancy-associated hypertension or diabetes. )
- Intention to seek pediatric care at one of two pediatric primary care sites
- Medicaid insurance
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Usual Care Care Coordination after Preterm Birth (CCAPB) Usual care participants will not receive the intervention. CCAPB (intervention) Care Coordination after Preterm Birth (CCAPB) Intervention participants will receive an intervention focused on health care navigation and motivational enhancement.
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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.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.
Tobacco use up to 1 month Tobacco use will be assessed by asking participants "Have you smoked any cigarettes in the past 30 days?"
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.
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.
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.
Multivitamin use up to 6 months Multivitamin use will be assessed by asking participants "Are you currently taking a multivitamin?"
Trial Locations
- Locations (1)
Hospital of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States