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Amelioration of Literacy Deficits in Prenatal Care

Amelioration of Literacy Deficits in Prenatal Care

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05974865
Enrollment
355
Registered
2023-08-03
Start date
2006-09-30
Completion date
2011-06-30
Last updated
2023-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Literacy, Numeracy, Prenatal Care

Keywords

patient-physician communication, patient activation intervention, RIAS, health literacy, spoken literacy

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.

Detailed description

The primary aim of the study is to develop and evaluate a skills-based, interactive computer intervention designed to enhance the communication skills of pregnant women with restricted literacy. To this end, a randomized trial compared a skill-based computer intervention to a facilitated review of pertinent print-based educational material on communication processes and its consequences. Intervention impact was evaluated through medical visit recordings and post-visit assessments by patients and clinicians. We hypothesized that women assigned to the skills-based, computer intervention would demonstrate greater use of targeted skills, be more actively engaged in the communication process, and experience more patient-centered visits than women assigned to the print-based intervention. We also hypothesized that computer use would result in greater visit satisfaction and closer patient and clinician alignment in their assessment of the patient's physical and emotional health status.. Study Design included 84 women seeing 19 obstetrical clinicians were randomized to use an interactive, skill-based, computer program or to a personalized review of a prenatal guide. Prenatal visits were recorded and coded using the Roter Interaction Analysis System (RIAS). Post-visit satisfaction and perceptions of physical and emotional health were reported. Analysis adjusted for the nesting of patients within physicians, gestation, literacy and visit length.

Interventions

BEHAVIORALHealthy Babies and Healthy Moms
BEHAVIORALBaby Basics Prenatal Guide

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
CollaboratorNIH
Johns Hopkins Bloomberg School of Public Health
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
16 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

\-

Design outcomes

Primary

MeasureTime frameDescription
patient-centered communicationBaselineAudio recordings of the prenatal visits are coded using the Roter Interaction Analysis System (RIAS). The communication outcome measure is derived from this coding.

Secondary

MeasureTime frameDescription
depression as assessed by the Edinburgh Depression Scalepost medical visit up to 8 monthsThe correlation between patient score on the The Edinburgh Depression Scale and the clinician's rating of signs of emotional state. The Edinburgh has 10 items items on a 4 point scale with score range 10-40. Higher scores indicating more symptoms of depression. Clinician completed a novel post visit assessment of the participant's emotional state asking to indicate signs of anxiety and depression observed during the recorded visit. 1 (no signs), 2 (some symptoms, but no illness), ), 3 (mild case), 4 (moderate case), 5 (severe case). Higher ratings indicated more significant anxiety and depression.

Other

MeasureTime frameDescription
patient satisfaction as assessed by a questionnaire developed by the study teampost medical visit up to 8 monthsPatient satisfaction with medical visit as assessed by a questionnaire developed by the study team. The measure consisted of 8 items on a 5-point scale ranging from poor (1) to excellent (5). Scale scores range from 8- 40.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026