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Completed

NCT Number: NCT05974865

Amelioration of Literacy Deficits in Prenatal Care

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.

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Key information

Age range

16 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins Hospital

Baltimore, Maryland, 21205, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

-

Treatment and study plan

Healthy Babies and Healthy Moms

Behavioral

Baby Basics Prenatal Guide

Behavioral

Primary outcomes

  1. patient-centered communication

    Time frame: Baseline

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

Secondary outcomes

  1. depression as assessed by the Edinburgh Depression Scale

    Time frame: post medical visit up to 8 months

    The 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 outcomes

  1. patient satisfaction as assessed by a questionnaire developed by the study team

    Time frame: post medical visit up to 8 months

    Patient 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.

Sponsors and collaborators

Lead sponsor

Johns Hopkins Bloomberg School of Public Health

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Important dates

Study start
2006
Primary completion
2011
Study completion
2011
First posted
Aug 3, 2023
Registry last updated
Aug 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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