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Clinical Trials/NCT06133829
NCT06133829
Active, not recruiting
Not Applicable

upREACH Perinatal Home Visitation Program Randomized Controlled Trial

Baylor College of Medicine1 site in 1 country450 target enrollmentJanuary 22, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pregnancy
Sponsor
Baylor College of Medicine
Enrollment
450
Locations
1
Primary Endpoint
Linkages to Community Resources
Status
Active, not recruiting
Last Updated
last month

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
January 22, 2024
End Date
November 30, 2026
Last Updated
last month
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Cary Cain

Assistant Professor

Baylor College of Medicine

Eligibility Criteria

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)

Outcomes

Primary Outcomes

Linkages to Community Resources

Time Frame: through study completion, an average of 5 months

Measured by Family Resource Scale (higher score shows that resources are more adequate)

Health Self-Efficacy

Time Frame: through study completion, an average of 5 months

Measured by Self-Rated Abilities for Health Practices Scale (higher scores indicate higher health self-efficacy)

Maternal Stress

Time Frame: through study completion, an average of 5 months

Perceived Stress Scale (higher scores indicate higher levels of stress)

Secondary Outcomes

  • Trust in Institutions(through study completion, an average of 5 months)
  • Appointment Adherence(up to one year postpartum)

Study Sites (1)

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