COMPLETED

Health and Wellness After Preterm Birth

Conditions

Preterm Birth Health Care Utilization Tobacco Use Contraceptive Usage Depression Weight, Birth Preconception Care Interconception care Postpartum care Preventive health care Care coordination Motivational Interviewing

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-07-17

Study Completion:2025-10-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT05756634

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:14 Years to 45 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:Yes

Standard Ages:CHILD, ADULT

Inclusion Criteria	Exclusion 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 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.

Inclusion Criteria

Exclusion 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 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.

Contacts and Locations

Principal Investigator

Emily Gregory, MD, MPH

PRINCIPAL_INVESTIGATOR

Children's Hospital of Philadelphia

Study Locations (Sites)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104

United States

Collaborators and Investigators

Sponsor: Children's Hospital of Philadelphia

Emily Gregory, MD, MPH, PRINCIPAL_INVESTIGATOR, Children's Hospital of Philadelphia

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-07-17

Study Completion Date2025-10-30

Study Record Updates

Study Start Date2023-07-17

Study Completion Date2025-10-30

Terms related to this study

Keywords Provided by Researchers

Preconception Care
Interconception care
Postpartum care
Preventive health care
Care coordination
Motivational Interviewing

Additional Relevant MeSH Terms

Preterm Birth
Health Care Utilization
Tobacco Use
Contraceptive Usage
Depression
Weight, Birth