upREACH Perinatal Home Visitation Program
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.
Conditions:
🦠 Pregnancy 🦠 Postpartum
🗓️ Study Start (Actual) 22 January 2024
🗓️ Primary Completion (Estimated) 28 February 2025
✅ Study Completion (Estimated) 31 August 2025
👥 Enrollment (Estimated) 400
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Houston, Texas, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Pregnant or postpartum women within 3 weeks postpartum (at enrollment)
    • * Receiving prenatal or postpartum care from Harris Health Clinic obstetric clinics
    • * Speak and read English or Spanish language.

    Exclusion Criteria:

    • * Unable to speak or read English or Spanish language
    • * Women that do not receive perinatal or postpartum care at Harris Health obstetric clinics
    • * Women that are not pregnant or greater than 4 weeks postpartum (at enrollment)
Ages Eligible for Study: N/A to N/A (CHILD, ADULT, OLDER_ADULT)
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: No

🗓️ 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

  • First Submitted 19 October 2023
  • First Submitted that Met QC Criteria 14 November 2023
  • First Posted 18 November 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 23 January 2024
  • Last Update Posted 24 January 2024
  • Last Verified January 2024