Ignite Creation Date:
2024-10-25 @ 7:53 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06575205
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2023-08-14
Brief Title:
Patient Education Video to Reduce OTC NSAIDs
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Brief Patient Educational Video to Reduce Potentially Harmful Over-the-counter Nonsteroidal Anti-inflammatory Drug NSAID Use
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 andor 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 andor 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 capabilityopportunitymotivation to change behavior pain and barriers to decreasing OTC NSAIDs Findings will inform future population health initiatives to reduce potentially harmful OTC NSAIDs use
Detailed Description:
Nonsteroidal anti-inflammatory drugs NSAIDs are effective in treating pain and inflammation but are also associated with multiple risks for some patients Numerous organizations recommend that older adults and patients with chronic diseases such as kidney disease heart failure and hypertension avoid chronic use of NSAIDs However high-risk use persists at undesirable rates The goal of this study is to assess the efficacy of an original brief 3 to 5 minute educational video on influencing intent to change behavior regarding potentially harmful over-the-counter OTC NSAID use The study population will involve adult patients from a large regional health system in the southeastern US with a diagnosis of chronic kidney disease CKD heart failure HF andor hypertension HTN as NSAID use is contraindicated in this population
All patients with a diagnosis of CKD HF andor HTN who have an email address on file will be invited to participate via emailREDCap 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 Spearmans correlation analysis will also be performed between all variables Significance will be set at the 005 level
Results of this study will inform population health interventions to reduce potentially harmful OTC NSAIDs use
All patients with a diagnosis of CKD HF andor HTN who have an email address on file will be invited to participate via emailREDCap 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 Spearmans correlation analysis will also be performed between all variables Significance will be set at the 005 level
Results of this study will inform population health interventions to reduce potentially harmful OTC NSAIDs use
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None