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Behavioural Intervention

Standard Information for Knowledge, Attitudes, and Practices (KAP)

N/A

Recruiting

Research Sponsored by Carnegie Mellon University

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 day 1

Awards & highlights

Study Summary

This trial aims to determine if a new one-page FDA-template for patient medication information is helpful compared to the current drug information insert. Participants will be given one of three information sheets and asked questions about their

Who is the study for?

This trial is for individuals in the US, aged 18-45, who were assigned female at birth. It's not open to those over 45 years old, under 18, or assigned a different sex at birth.Check my eligibility

What is being tested?

The study is testing three types of patient medication information sheets: one based on the FDA's proposed template, another with standard info, and a third that adds drug benefit details. Participants will be randomly given one sheet to review for usefulness and comprehension.See study design

What are the potential side effects?

Since this trial involves reviewing information sheets rather than taking medications or undergoing treatments, there are no direct physical side effects associated with participating.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1

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

Treatment Details

Study Objectives

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

Primary outcome measures

Comprehension

Perceived difficulty or ease in reading information

Perceived usefulness of the medication information guide in making a use decision

+1 more

Secondary outcome measures

Strength of Evidence

Trial Design

3Treatment groups

Experimental Treatment

Group I: Standard InformationExperimental Treatment1 Intervention

Standard of care patient medication information

Group II: FDA-template PMIExperimental Treatment1 Intervention

Patient medication information designed according to FDA template

Group III: Decision Critical PMIExperimental Treatment1 Intervention

Patient medication information designed according to FDA template and modified, according to decision science principles, to include benefit information

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Carnegie Mellon UniversityLead Sponsor

76 Previous Clinical Trials

539,600 Total Patients Enrolled

University of PittsburghOTHER

1,722 Previous Clinical Trials

16,342,606 Total Patients Enrolled

Frequently Asked Questions

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

Are new participants still being accepted for enrollment in this research study?

"As per clinicaltrials.gov, recruitment for this research is currently ongoing. This trial was first listed on 3/3/2024 and last modified on 3/13/2024."

Answered by AI

What is the current number of subjects enrolled in this medical study?

"Indeed, the information provided on clinicaltrials.gov indicates that this study is currently in search of suitable candidates. The trial was initially published on March 3rd, 2024 and last modified on March 13th, 2024. It aims to recruit a total of 330 participants from one designated site."

Answered by AI

Do I meet the requirements to be considered as a potential candidate for this medical study?

"Prospective candidates must demonstrate appropriate knowledge, attitudes, and practices (KAP) and be aged between 18 and 45 years old to qualify for enrollment in this medical study. A total of 330 participants will be accepted into the trial."

Answered by AI

Is there an inclusion criteria for participants above the age of 85 in this research investigation?

"Individuals aged between 18 and 45 are eligible for participation in this research project. Furthermore, there are 6 investigations designated for individuals under the age of majority and 14 targeted towards those above the age of retirement."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Evaluating FDA's Proposed Patient Medication Information Handout

Baruch Fischhoff 2024. "Evaluating FDA's Proposed Patient Medication Information Handout". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06320808.

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