Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
1452 participants
INTERVENTIONAL
2023-08-02
2025-03-15
Brief Summary
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Detailed Description
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All patients with a diagnosis of CKD, HF, and/or HTN, who have an email address on file will be invited to participate via email/REDCap. Upon clicking the link, general study information will be provided for participant informed consent and a printable IRB subject informational sheet will be made available to all potential participants and participants. After acknowledgment by the participant, a pre-educational survey will assess recent use of over-the-counter NSAIDs and general demographic information. Those who meet criteria for regular NSAIDs use (\>3 doses per week over previous 3 months) will be immediately invited to participate in a randomized controlled trial (Education Tool Survey accompanied by VIDEO or CONTROL).
Participants will answer 3 additional baseline pain level survey questions and 1 additional question regarding their baseline intent to change their current use of OTC NSAIDs. Participants will then immediately be randomized to either view the brief 3 to 5 minute educational video (VIDEO) on their own device covering themes that are already covered on the FDA warning label such as: defining OTC NSAIDs, potential harms of NSAIDs, and alternatives or participants will view a standard OTC NSAIDs FDA warning label (CONTROL). Trial participants will complete a survey electronically immediately after viewing VIDEO or CONTROL covering questions about intent to change behaviors related to OTC NSAID use and barriers, capability, opportunity, and motivation to change behaviors. This portion of the study will take less than 10 minutes to complete.
Trial participants will complete a survey electronically again 4 weeks later regarding questions about intent to change the use of OTC NSAIDs, actual use of OTC NSAIDs (for the recent 4 week time period), levels of pain, and barriers, capability, opportunity, and motivation to change behaviors. REDCap will auto-send the 4 week survey 4 weeks after completion of the Education Tool Survey. This portion of the study will take less than 5 minutes to complete.
The study team will perform a multivariable linear regression to evaluate the association of demographics on OTC NSAID use. The study team will use paired t-tests to evaluate group and time differences. The study team will use stepwise forward multivariable linear regression to evaluate the relative impact of secondary outcomes (barriers, capability, opportunity, and motivation to change behaviors, and ratings of pain) on intent to change NSAID use. Spearman's correlation analysis will also be performed between all variables. Significance will be set at the 0.05 level.
Results of this study will inform population health interventions to reduce potentially harmful OTC NSAIDs use.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
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Video
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.
Educational video
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.
Control
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.
No interventions assigned to this group
Interventions
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Educational video
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.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Virginia Polytechnic Institute and State University
OTHER
Carilion Clinic
OTHER
Responsible Party
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Michelle Rockwell
Assistant Professor, Principal Investigator
Principal Investigators
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Michelle Rockwell, PhD, RD
Role: PRINCIPAL_INVESTIGATOR
Carilion Clinic
Locations
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Carilion Clinic Riverside 1
Roanoke, Virginia, United States
Countries
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References
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Other Identifiers
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IRB-22-1766
Identifier Type: -
Identifier Source: org_study_id