ACTIVE_NOT_RECRUITING

upREACH Perinatal Home Visitation Program

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

The purpose of this study is to assess the effectiveness of a new brief home visitation program delivered by non-nurse home visitors to 1) improve connections to community resources based on reported and assessed needs, 2) increase health self-efficacy, and 3) reduce maternal stress compared to a control group that receives standard care from an obstetric clinic. Secondary administrative data on infant birth outcomes, health care use during the first year of life (appointment adherence), and interaction with government services (such as public assistance or child welfare) will be compared between the groups. For the intervention group, we will secondarily also assess home visit compliance and satisfaction with the intervention. Participants will be asked to complete questionnaires that include questions about the participant, their pregnancy, their feelings, their family, and their use of social/community services. Half of the women in this study will be randomly offered free home visitation services and the other half of women in this study will receive standard services from the clinic. The intervention group will be offered at least two free home visits with a non-nurse home visitor. During these visits, the home visitor will provide them with resources and tools to help the participant prepare for their baby. All participants will complete a second round of electronic surveys at approximately 2 months postpartum. Intervention participant outcomes will be compared to a control group that receive standard care from an obstetric clinic.

Official Title

upREACH Perinatal Home Visitation Program Randomized Controlled Trial

Quick Facts

Study Start:2024-01-22
Study Completion:2026-11-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06133829

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:Not specified
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Pregnant or postpartum women within 3 weeks postpartum (at enrollment)
  2. * Receiving prenatal or postpartum care from Harris Health Clinic obstetric clinics
  3. * Speak and read English or Spanish language.
  1. * Unable to speak or read English or Spanish language
  2. * Women that do not receive perinatal or postpartum care at Harris Health obstetric clinics
  3. * Women that are not pregnant or greater than 4 weeks postpartum (at enrollment)

Contacts and Locations

Principal Investigator

Cary M Cain, PhD
PRINCIPAL_INVESTIGATOR
Baylor College of Medicine

Study Locations (Sites)

Harris Health/Baylor College of Medicine
Houston, Texas, 77047
United States

Collaborators and Investigators

Sponsor: Baylor College of Medicine

  • Cary M Cain, PhD, PRINCIPAL_INVESTIGATOR, Baylor College of Medicine

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 Date2024-01-22
Study Completion Date2026-11-30

Study Record Updates

Study Start Date2024-01-22
Study Completion Date2026-11-30

Terms related to this study

Additional Relevant MeSH Terms

  • Pregnancy
  • Postpartum