Ignite Creation Date:
2024-05-06 @ 7:47 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06133829
Status:
RECRUITING
Last Update Posted:
2024-01-24
First Post:
2023-10-19
Brief Title:
upREACH Perinatal Home Visitation Program
Sponsor:
Baylor College of Medicine
Organization:
Baylor College of Medicine
Study Overview
Official Title:
upREACH Perinatal Home Visitation Program Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
upREACH
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 socialcommunity 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
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 socialcommunity 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 62823-S1 | OTHER_GRANT | DFPS | None |