upREACH Perinatal Home Visitation Program

Pregnancy Clinical Trial

— upREACH  

Official title:

upREACH Perinatal Home Visitation Program Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06133829
• Other study ID #: H-53998
• Secondary ID: 62823-S1
• Status: Recruiting
• Phase: N/A
• Start date: January 22, 2024
• Est. completion date: August 31, 2025

Study information

• Verified date: January 2024
• Source: Baylor College of Medicine
• Contact: Cary M Cain, PhD
• Phone: 832-824-0252
• Email: Cary.Cain[@]bcm.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: August 31, 2025
• Est. primary completion date: February 28, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Postpartum
• Pregnancy

Intervention

Behavioral:
• upREACH Home Visitation Program
upREACH is a brief perinatal home visitation program delivered by community health workers or similarly qualified personnel. The mission statement of the program is: Families are prepared to bring home their newborn to a safe, stable, and nurturing environment, and have access to tools, resources, and knowledge that promote family health and well-being. Through the program, families will receive a minimum of 2 home visits during pregnancy and/or postpartum from a home visitor (community health worker (CHW) or similarly qualified personnel). The home visitor will assess each family's strengths and needs so they may provide tailored support and brief education to promote maternal health and self-care, infant health and safety, and connection to and knowledge of resources (community orientation).

Locations

Country	Name	City	State
United States	Harris Health/Baylor College of Medicine	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Baylor College of Medicine	Texas Department of Family Protective Services

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Linkages to Community Resources	Measured by Family Resource Scale (higher score shows that resources are more adequate)	through study completion, an average of 5 months
Primary	Health Self-Efficacy	Measured by Self-Rated Abilities for Health Practices Scale (higher scores indicate higher health self-efficacy)	through study completion, an average of 5 months
Primary	Maternal Stress	Perceived Stress Scale (higher scores indicate higher levels of stress)	through study completion, an average of 5 months
Secondary	Trust in Institutions	Measured by Trust in Institutions Instrument (higher scores indicate higher trust)	through study completion, an average of 5 months
Secondary	Appointment Adherence	Medical Chart Review of number of appointments attended with Obstetric and Gynecological (OB/GYN) and Pediatric Providers and Self-Report by the participant number of appointments with OB/GYN and Pediatric Appointments	up to one year postpartum