← Back to Search

Improved OTC Drug Labels for Preventing Adverse Drug Reactions in Older Adults

N/A

Waitlist Available

Led By Mark W Becker, PhD

Research Sponsored by Michigan State University

Eligibility Criteria Checklist

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

Must have

Participant must be 65+

Participant must be able to purchase and administer their own medications

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 60 minutes

Awards & highlights

Study Summary

This trial showed that older adults need labels that are easier to read and provide more information in order to minimize adverse drug events.

Who is the study for?

This trial is for individuals aged 65 and older who can buy and use their own medications, are legally able to see, and can consent without help. It's not for those with a history of seizures or impaired memory.Check my eligibility

What is being tested?

The study is testing the effectiveness of redesigned over-the-counter drug labels to help older adults understand how to use medications safely to avoid adverse reactions.See study design

What are the potential side effects?

Since this trial involves label comprehension rather than medication intake, there are no direct side effects from interventions being studied.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 65 years old or older.

Select...

I can buy and take my own medications.

Select...

I can understand and sign the consent form by myself.

Select...

I am legally able to see.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 60 minutes

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~60 minutes

This trial's timeline: 3 weeks for screening, Varies for treatment, and 60 minutes for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Change Detection in Over the Counter Medicine Labels

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Condition 4- FOP+Highlighting labelExperimental Treatment1 Intervention

This condition will combine both the highlighting and FOP labeling interventions from conditions 2 and 3. Note: Across the four arms we are essentially doing a 2 (highlighting/no highlighting) by 2 (front of pack warning/ no front of pack warning) within subjects design.

Group II: Condition 3 - FOP warning labelExperimental Treatment1 Intervention

This condition will involve presenting critical drug/drug, and drug/diagnosis information in a novel Front-of-Pack (FOP) warning label.

Group III: Condition 2 - HighlightedExperimental Treatment1 Intervention

This condition will involve a novel method of presenting critical active ingredient, drug/drug, and drug/diagnosis information with highlighting.

Group IV: Condition 1 - ControlActive Control1 Intervention

We note that our within subjects experimental design, in which each subject receives all treatments, is not well suited to this system of reporting. Thus we are defining "arms" as the label treatments we are evaluating. This label is the control label treatment which represents the current, legally required over-the-counter labeling standard.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Michigan State UniversityLead Sponsor

185 Previous Clinical Trials

601,607 Total Patients Enrolled

University of Wisconsin, MadisonOTHER

1,189 Previous Clinical Trials

3,169,126 Total Patients Enrolled

Mark W Becker, PhDPrincipal InvestigatorMichigan State University

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 participate in this research endeavor?

"Aiming to recruit 420 participants, this clinical trial is seeking out individuals aged 65-110 who have previously experienced adverse drug events (ADEs)."

Answered by AI

Are researchers still accepting participants for this research project?

"Affirmative. According to clinicaltrials.gov, the search for participants is still ongoing and has been since July 16th 2018. The last update was on April 7th 2022 when 420 patients from one medical centre were being recruited."

Answered by AI

Is this research endeavor restricted to individuals under the age of twenty or are there no limits on enrollment?

"Requirements to participate in this trial specify that potential subjects must between the ages of 65 and 110. There are 8 studies for people under 18 years old and 40 for those over 65."

Answered by AI

How many participants are currently registered for the trial?

"Affirmative. The information on the clinicaltrials.gov website shows that this research study is actively looking for participants, with an original posting date of July 16th 2018 and a most recent update from April 7th 2022. This experiment needs 420 individuals across one medical centre to take part in it."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Over-the-counter (OTC) Labels for Older Adults

Mark Becker 2018. "Over-the-counter (OTC) Labels for Older Adults". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04345731.