NCT05974865

Brief Summary

The purpose of the study was to develop and evaluate a skill-based, computer intervention designed to facilitate effective prenatal visit communication for women with restricted literacy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
355

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

July 22, 2014

Completed
9 years until next milestone

First Posted

Study publicly available on registry

August 3, 2023

Completed
Last Updated

August 3, 2023

Status Verified

July 1, 2023

Enrollment Period

4.8 years

First QC Date

July 22, 2014

Last Update Submit

July 26, 2023

Conditions

Prenatal CareHealth LiteracyNumeracy

Keywords

patient-physician communicationpatient activation interventionRIAShealth literacyspoken literacy

Outcome Measures

Primary Outcomes (1)

  • patient-centered communication

    Audio recordings of the prenatal visits are coded using the Roter Interaction Analysis System (RIAS). The communication outcome measure is derived from this coding.

    Baseline

Secondary Outcomes (1)

  • depression as assessed by the Edinburgh Depression Scale

    post medical visit up to 8 months

Other Outcomes (1)

  • patient satisfaction as assessed by a questionnaire developed by the study team

    post medical visit up to 8 months

Study Arms (2)

Healthy Babies and Health Moms

EXPERIMENTAL

Healthy Babies and Healthy Moms was designed as a 20-minute communication skills-based computer program based on key social learning principles designed to empower women to more actively and productively use targetted skills to improve the medical dialogue of their prenatal visits.

Behavioral: Healthy Babies and Healthy Moms

Baby Basics Prenatal Guide

ACTIVE COMPARATOR

The Baby Basics Prenatal Guide, published by the What to Expect Foundation, was used in a face-to-face educational session with a study research assistant during which pregnancy related information was personalized by reviewing relevant sections of the Baby Basics prenatal guide.

Behavioral: Baby Basics Prenatal Guide

Interventions

Healthy Babies and Healthy MomsBEHAVIORAL
Healthy Babies and Health Moms
Baby Basics Prenatal GuideBEHAVIORAL
Baby Basics Prenatal Guide

Eligibility Criteria

Age16 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Pregnant women attending study prenatal clinics with consenting clinicians. English speaking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21205, United States

Location

Study Officials

  • Debra Roter, PhD

    Johns Hopkins Bloomberg School of Public Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 22, 2014

First Posted

August 3, 2023

Study Start

September 1, 2006

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

August 3, 2023

Record last verified: 2023-07

Locations

US(1)