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Behavioral Intervention

Obstetric Prenatal Genetic Testing Engagement Solution (OPUS) AI Chatbot for Prenatal Disorder (OPUS Trial)

N/A

Waitlist Available

Led By Ruth Farrell, MD, MA

Research Sponsored by The Cleveland Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1-day

Awards & highlights

OPUS Trial Summary

This trial aims to develop a digital tool called Obstetric Prenatal Genetic Testing Engagement Solution (OPUS) to help pregnant patients make informed decisions about Prenatal Screening & Diagnostic Testing (PS&D

Who is the study for?

This trial is for pregnant individuals who need support in making informed decisions about Prenatal Screening & Diagnostic Testing (PS&D). Participants should be interested in using a digital tool, OPUS AI Chatbot, to help with their decision-making process. The eligibility criteria are not fully listed but would typically include factors like gestational age and health status.Check my eligibility

What is being tested?

The study tests an artificial intelligence chatbot named OPUS designed to aid pregnant patients in understanding and deciding on genetic testing options during pregnancy. It compares the outcomes of those using this innovative digital tool against standard care without the chatbot.See study design

What are the potential side effects?

Since this intervention involves information and decision-making support through a chatbot rather than medical treatment, traditional side effects are not applicable. However, there may be psychological impacts or stress related to engaging with genetic testing information.

OPUS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1-day

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1-day

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1-day for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Patient activation

OPUS Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Obstetric Prenatal Genetic Testing Engagement Solution (OPUS) AI ChatbotExperimental Treatment1 Intervention

This arm will utilize an artificial intelligence AI enabled healthcare chatbot that provides patients with personalized information and decision-making support at different stages of the prenatal screen and diagnostic testing pathways.

Group II: Standard of carePlacebo Group1 Intervention

This group will utilize standard care with respect to healthcare provider practices for education and counseling surrounding prenatal screening and diagnostic testing options.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

The Cleveland ClinicLead Sponsor

1,030 Previous Clinical Trials

1,364,958 Total Patients Enrolled

1 Trials studying Prenatal Disorder

644 Patients Enrolled for Prenatal Disorder

Ruth Farrell, MD, MAPrincipal InvestigatorThe Cleveland Clinic

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it feasible for me to be a participant in this clinical investigation?

"To be considered for enrollment in this study, individuals must have a confirmed prenatal condition and fall between the ages of 18 to 50. The trial aims to recruit a total of 600 participants."

Answered by AI

Is the research study open to individuals aged 55 and above?

"Individuals aged 18 and older but under the age of 50 are eligible for enrollment in this research."

Answered by AI

Is the registration process currently ongoing for this clinical trial?

"The information available on clinicaltrials.gov indicates that recruitment for this research project is currently closed. Initially posted on May 31, 2024, and last modified on April 23, 2024. Despite the current inactivity of this trial for patient enrollment, three other studies are actively seeking participants at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Engaging Patients in Prenatal Genetic Testing Decisions as a Pathway to Improve Obstetric Outcomes

2024. "Engaging Patients in Prenatal Genetic Testing Decisions as a Pathway to Improve Obstetric Outcomes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06382636.