Educational Video for Reducing NSAID Use in Chronic Conditions

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Carilion Clinic

Disqualifiers: Not Carilion patients, Under 18, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

1452 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this study is to assess the efficacy of a brief 3 to 5-minute educational video on influencing intent to change behavior regarding potentially harmful over-the-counter (OTC) NSAID use in adults with chronic kidney disease (CKD), heart failure (HF), and/or hypertension (HTN). Informed by the COM-B model of behavior change, the video reviews identifying OTC NSAIDs, potential risks of NSAIDs, and general alternatives to potentially harmful NSAIDs. Participants with CKD, HF, and/or HTN identified as regular OTC NSAID users will be randomized to the VIDEO or CONTROL group. They will complete surveys immediately and 4 weeks after viewing the VIDEO or CONTROL to assess actual NSAIDs use, intent to change behavior related to NSAIDs use, capability/opportunity/motivation to change behavior, pain, and barriers to decreasing OTC NSAIDs. Findings will inform future population health initiatives to reduce potentially harmful OTC NSAIDs use.

Research Team

Michelle Rockwell, PhD, RD

Principal Investigator

Carilion Clinic

Eligibility Criteria

This trial is for adults with chronic kidney disease, heart failure, or high blood pressure who regularly use over-the-counter NSAIDs. It aims to see if a short educational video can change their behavior and reduce the use of these potentially harmful medications.

Inclusion Criteria

Carilion Clinic patients

I have been diagnosed with chronic kidney disease, high blood pressure, or heart failure.

E-mail address or phone number on file

Exclusion Criteria

I do not have chronic kidney disease, high blood pressure, or heart failure.

No e-mail address or phone number on file

Cannot speak or read English

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Baseline Assessment

Participants complete a pre-educational survey assessing recent use of OTC NSAIDs and demographic information

Less than 10 minutes

1 visit (virtual)

Intervention

Participants are randomized to view either a brief educational video or a static FDA warning label about OTC NSAIDs

3-5 minutes

1 visit (virtual)

Immediate Post-Intervention Assessment

Participants complete a survey immediately after viewing the video or control to assess intent to change behavior and other factors

Less than 10 minutes

1 visit (virtual)

Follow-up

Participants complete a survey 4 weeks later to assess changes in NSAID use and other behavioral factors

4 weeks

1 visit (virtual)

Treatment Details

Interventions

• Patient Education Video

Trial Overview The study tests whether a brief educational video can influence people with certain chronic conditions to reconsider their use of over-the-counter pain relievers known as NSAIDs. Participants are randomly assigned to watch the video or be in a control group without it.

Participant Groups

Group I: Video Experimental Treatment 1 Intervention

An original brief 3 to 5 minute educational video, covering themes such as: defining OTC NSAIDs and their uses, potential harms of NSAIDs, and broad general alternatives. Will involve suggestion to speak to their healthcare provider.

Group II: Control Active Control 1 Intervention

A static image of a standardized FDA warning label for OTC NSAIDs covering themes such as: uses of OTC NSAIDs, potential harms of NSAIDs, and suggestion to speak to their healthcare provider.

Who Is Running the Clinical Trial?

Carilion Clinic

Lead Sponsor

Trials

85

Recruited

15,400+

Virginia Polytechnic Institute and State University

Collaborator

Trials

162

Recruited

26,900+