Patient Education Video to Reduce OTC NSAIDs

NCT06575205 | Active Not Recruiting

• 1 other identifier: IRB-22-1766
• Study Type: interventional
• Target: 1,452
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Kidney Diseases; Heart Failure; Hypertension

Keywords

Chronic Kidney Diseases; Heart Failure; Hypertension; Over the Counter NSAIDS

Outcome Measures

Primary Outcomes (2)

• Contemplation Ladder score

  Intent to change behavior related to OTC NSAID use, scored from 0 (no intent to decrease OTC NSAID use) to 10 (already committed to decreasing OTC NSAID use). A higher score is the better outcome (greater intent to decrease high-risk OTC NSAIDs).

  baseline prior to viewing VIDEO or CONTROL and within 10 minutes after viewing VIDEO or CONTROL and 4 weeks later

• Self-reported OTC NSAID use

  NSAID use over the past 30 days, reported as number of days during the past 30 that OTC NSAIDs were used. The range of responses is 0 to 30.

  baseline prior to viewing VIDEO or CONTROL and 4 weeks later

Secondary Outcomes (5)

• Barriers to decreasing OTC NSAIDs use

  baseline prior to viewing VIDEO or CONTROL and 4 weeks later

• Capability to decrease OTC NSAIDs use score

  baseline prior to viewing VIDEO or CONTROL and 4 weeks later

• Motivation to decrease OTC NSAIDs use score

  baseline prior to viewing VIDEO or CONTROL and 4 weeks later

• Rating of pain score

  baseline prior to viewing VIDEO or CONTROL and 4 weeks later

• Opportunity to decrease OTC NSAIDs use score

  baseline prior to viewing VIDEO or CONTROL and 4 weeks later

Study Arms (2)

Video

EXPERIMENTAL

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.

Behavioral: Educational video

Control

NO 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.

Interventions

Educational video BEHAVIORAL

Participants will view a brief 3-to-5-minute educational video (VIDEO), covering information that is already printed on FDA labels for OTC NSAIDs, on their own device covering themes such as: defining OTC NSAIDs, potential harms of NSAIDs, and alternatives.

Video

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Carilion Clinic patients
• Age \> = 18 years
• Diagnosis of CKD, HTN, and/or HF
• E-mail address or phone number on file.
• Able to speak and read English
• Able to respond to an online survey and view a video

You may not qualify if:

• Not Carilion Clinic patients
• Age \< 18
• No diagnosis of CKD, HTN, or HF
• No e-mail address or phone number on file
• Cannot speak or read English
• Not able to respond to an online survey or view a video

Sponsors & Collaborators

• Carilion Clinic: lead
• Virginia Polytechnic Institute and State University: collaborator

Study Sites (1)

Carilion Clinic Riverside 1

Roanoke, Virginia, 24016, United States

Location

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MeSH Terms

Conditions

Renal Insufficiency, Chronic; Heart Failure; Hypertension

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Michelle Rockwell, PhD, RD

  Carilion Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Principal Investigator

Study Record Dates

• First Submitted: August 14, 2023
• First Posted: August 28, 2024
• Study Start: August 2, 2023
• Primary Completion: January 28, 2024
• Study Completion: March 15, 2025
• Last Updated: September 3, 2024

Record last verified: 2024-08

Locations

US (1)