Chronic Kidney DiseasesNCT06575205
Patient Education Video to Reduce OTC NSAIDs
A study testing Educational video in people with Chronic Kidney Diseases and Heart Failure, run by Carilion Clinic at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Diseases, Heart Failure, Hypertension
- What is being tested?
- Educational video
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,452 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Aug 2023to 15 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Carilion Clinic Riverside 1
Roanoke, Virginia, 24016
About this study
Official title: A Brief Patient Educational Video to Reduce Potentially Harmful Over-the-counter Nonsteroidal Anti-inflammatory Drug (NSAID) Use
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.
Read the 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 U.S. with a diagnosis of chronic kidney disease (CKD), heart failure (HF), and/or hypertension (HTN) as NSAID use is contraindicated in this population.
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
- Chronic Kidney Diseases, Heart Failure, Hypertension
- Being tested
- Educational video
- Keywords
- Chronic Kidney Diseases, Heart Failure, Hypertension, Over the Counter NSAIDS
- Medical subject headings
- Renal Insufficiency, Chronic, Heart Failure, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational videoBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: baseline prior to viewing VIDEO or CONTROL and 4 weeks later
Secondary outcomes (5)
Barriers to decreasing OTC NSAIDs use
Participant response to open-ended survey question: What is the biggest barrier to decreasing your use of OTC NSAIDs?
Measured: baseline prior to viewing VIDEO or CONTROL and 4 weeks later
Capability to decrease OTC NSAIDs use score
2 survey questions focused on capability portion of COM-B model of behavior change. This question is scored on an 11-point likert scale, from 0 to 11. A score of 11 indicates the greatest perceived capability.
Measured: baseline prior to viewing VIDEO or CONTROL and 4 weeks later
Motivation to decrease OTC NSAIDs use score
2 survey questions focused on motivation portion of COM-B model of behavior change. This question is scored on an 11-point likert scale, from 0 to 11. A score of 11 indicates the greatest perceived motivation.
Measured: baseline prior to viewing VIDEO or CONTROL and 4 weeks later
Rating of pain score
Response to question: rate your pain over the past 30 days. This will be scored on a 6-point likert scale with 0=no pain and 5=severe pain.
Measured: baseline prior to viewing VIDEO or CONTROL and 4 weeks later
Opportunity to decrease OTC NSAIDs use score
2 survey questions focused on opportunity portion of COM-B model of behavior change. This question is scored on an 11-point likert scale, from 0 to 11. A score of 11 indicates the greatest perceived opportunity.
Measured: baseline prior to viewing VIDEO or CONTROL and 4 weeks later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2024
- Study start2 Aug 2023
- Primary completion28 Jan 2024
- Study completion15 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (29)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 1,452 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carilion Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Virginia Polytechnic Institute and State University
- Responsible party
- Principal investigator, Michelle Rockwell, Carilion Clinic
- Investigators
- Michelle Rockwell, PhD, RD, Principal investigator, Carilion Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06575205
- Sponsor's protocol ID
- IRB-22-1766
- Status last verified
- Aug 2024
- First submitted
- 14 Aug 2023
- Last updated
- 3 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Antman EM, Bennett JS, Daugherty A, Furberg C, Roberts H, Taubert KA; American Heart Association. Use of nonsteroidal antiinflammatory drugs: an update for clinicians: a scientific statement from the American Heart Association. Circulation. 2007 Mar 27;115(12):1634-42. doi: 10.1161/CIRCULATIONAHA.106.181424. Epub 2007 Feb 26. No abstract available.
PubMed 17325246Arfe A, Scotti L, Varas-Lorenzo C, Nicotra F, Zambon A, Kollhorst B, Schink T, Garbe E, Herings R, Straatman H, Schade R, Villa M, Lucchi S, Valkhoff V, Romio S, Thiessard F, Schuemie M, Pariente A, Sturkenboom M, Corrao G; Safety of Non-steroidal Anti-inflammatory Drugs (SOS) Project Consortium. Non-steroidal anti-inflammatory drugs and risk of heart failure in four European countries: nested case-control study. BMJ. 2016 Sep 28;354:i4857. doi: 10.1136/bmj.i4857.
PubMed 27682515Coxib and traditional NSAID Trialists' (CNT) Collaboration; Bhala N, Emberson J, Merhi A, Abramson S, Arber N, Baron JA, Bombardier C, Cannon C, Farkouh ME, FitzGerald GA, Goss P, Halls H, Hawk E, Hawkey C, Hennekens C, Hochberg M, Holland LE, Kearney PM, Laine L, Lanas A, Lance P, Laupacis A, Oates J, Patrono C, Schnitzer TJ, Solomon S, Tugwell P, Wilson K, Wittes J, Baigent C. Vascular and upper gastrointestinal effects of non-steroidal anti-inflammatory drugs: meta-analyses of individual participant data from randomised trials. Lancet. 2013 Aug 31;382(9894):769-79. doi: 10.1016/S0140-6736(13)60900-9. Epub 2013 May 30.
PubMed 23726390Choosing Wisely American Society of Nephrology NSAIDs Recommendation. https://www.choosingwisely.org/clinician-lists/american-society-nephrology-nsaids-in-individuals-with-hypertension-heart-failure-or-chronic-kidney-disease/, accessed March 2022
Davis JS, Lee HY, Kim J, Advani SM, Peng HL, Banfield E, Hawk ET, Chang S, Frazier-Wood AC. Use of non-steroidal anti-inflammatory drugs in US adults: changes over time and by demographic. Open Heart. 2017 Apr 28;4(1):e000550. doi: 10.1136/openhrt-2016-000550. eCollection 2017.
PubMed 28674622Davison SN, Koncicki H, Brennan F. Pain in chronic kidney disease: a scoping review. Semin Dial. 2014 Mar;27(2):188-204. doi: 10.1111/sdi.12196. Epub 2014 Feb 12.
PubMed 24517512Gates, B. J., Setter, S. M., Corbett, C. F., & Baker, D. E. (2005). A Comparison of Educational Methods to Improve NSAID Knowledge and Use of a Medication List in an Elderly Population. Home Health Care Management & Practice, 17(5), 403-410.
Green GA. Understanding NSAIDs: from aspirin to COX-2. Clin Cornerstone. 2001;3(5):50-60. doi: 10.1016/s1098-3597(01)90069-9.
PubMed 11464731Hales CM, Martin CB, Gu Q. Prevalence of Prescription Pain Medication Use Among Adults: United States, 2015-2018. NCHS Data Brief. 2020 Jun;(369):1-8.
PubMed 32600518Harirforoosh S, Asghar W, Jamali F. Adverse effects of nonsteroidal antiinflammatory drugs: an update of gastrointestinal, cardiovascular and renal complications. J Pharm Pharm Sci. 2013;16(5):821-47. doi: 10.18433/j3vw2f.
PubMed 24393558Koffeman AR, Valkhoff VE, Celik S, W't Jong G, Sturkenboom MC, Bindels PJ, van der Lei J, Luijsterburg PA, Bierma-Zeinstra SM. High-risk use of over-the-counter non-steroidal anti-inflammatory drugs: a population-based cross-sectional study. Br J Gen Pract. 2014 Apr;64(621):e191-8. doi: 10.3399/bjgp14X677815.
PubMed 24686883Labelle M, Beaulieu M, Paquette D, Fournier C, Bessette L, Choquette D, Rahme E, Thivierge RL. An integrated approach to improving appropriate use of anti-inflammatory medication in the treatment of osteoarthritis in Quebec (Canada): the CURATA model. Med Teach. 2004 Aug;26(5):463-70. doi: 10.1080/0142159042000218669.
PubMed 15369888Lefebvre C, Hindie J, Zappitelli M, Platt RW, Filion KB. Non-steroidal anti-inflammatory drugs in chronic kidney disease: a systematic review of prescription practices and use in primary care. Clin Kidney J. 2019 May 20;13(1):63-71. doi: 10.1093/ckj/sfz054. eCollection 2020 Feb.
PubMed 32082554Martin P, Tamblyn R, Benedetti A, Ahmed S, Tannenbaum C. Effect of a Pharmacist-Led Educational Intervention on Inappropriate Medication Prescriptions in Older Adults: The D-PRESCRIBE Randomized Clinical Trial. JAMA. 2018 Nov 13;320(18):1889-1898. doi: 10.1001/jama.2018.16131.
PubMed 30422193McDonald DD, Amendola MG, Interlandi E, Wall K, Lewchik B, Polouse L, Pace N, Inthavong S, Li L. Effect of reading additional safety information on planned use of over-the-counter analgesics. Public Health Nurs. 2007 May-Jun;24(3):230-8. doi: 10.1111/j.1525-1446.2007.00629.x.
PubMed 17456124
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Brief Patient Educational Video to Reduce Potentially Harmful Over-the-counter Nonsteroidal Anti-inflammatory Drug (NSAID) Use
- ClinicalTrials.gov ID
- NCT06575205
- Acronym / sponsor ID
- IRB-22-1766
- Conditions
- Chronic Kidney Diseases, Heart Failure, Hypertension
- Keywords
- Chronic Kidney Diseases, Heart Failure, Hypertension, Over the Counter NSAIDS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,452 participants (actual)
- Lead sponsor
- Carilion ClinicUniversity, hospital or other
- Collaborators
- Virginia Polytechnic Institute and State University
- Study start
- 2 Aug 2023 (actual)
- Primary completion
- 28 Jan 2024 (actual)
- Study completion
- 15 Mar 2025 (estimated)
- First posted
- 28 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 U.S. with a diagnosis of chronic kidney disease (CKD), heart failure (HF), and/or hypertension (HTN) as NSAID use is contraindicated in this population.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Video | Experimental | Behavioral: Educational videoAn 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational videoParticipants 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. | Behavioural | Video |
Primary outcome
Contemplation Ladder score
Time frame: baseline prior to viewing VIDEO or CONTROL and within 10 minutes after viewing VIDEO or CONTROL and 4 weeks later
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).
Self-reported OTC NSAID use
Time frame: baseline prior to viewing VIDEO or CONTROL and 4 weeks later
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.
5 secondary outcomes
Barriers to decreasing OTC NSAIDs use
Time frame: baseline prior to viewing VIDEO or CONTROL and 4 weeks later
Capability to decrease OTC NSAIDs use score
Time frame: baseline prior to viewing VIDEO or CONTROL and 4 weeks later
Motivation to decrease OTC NSAIDs use score
Time frame: baseline prior to viewing VIDEO or CONTROL and 4 weeks later
Rating of pain score
Time frame: baseline prior to viewing VIDEO or CONTROL and 4 weeks later
Opportunity to decrease OTC NSAIDs use score
Time frame: baseline prior to viewing VIDEO or CONTROL and 4 weeks later
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2024.
- Background: PubMed 17325246Antman EM, Bennett JS, Daugherty A, Furberg C, Roberts H, Taubert KA; American Heart Association. Use of nonsteroidal antiinflammatory drugs: an update for clinicians: a scientific statement from the American Heart Association. Circulation. 2007 Mar 27;115(12):1634-42. doi: 10.1161/CIRCULATIONAHA.106.181424. Epub 2007 Feb 26. No abstract available.
- Background: PubMed 27682515Arfe A, Scotti L, Varas-Lorenzo C, Nicotra F, Zambon A, Kollhorst B, Schink T, Garbe E, Herings R, Straatman H, Schade R, Villa M, Lucchi S, Valkhoff V, Romio S, Thiessard F, Schuemie M, Pariente A, Sturkenboom M, Corrao G; Safety of Non-steroidal Anti-inflammatory Drugs (SOS) Project Consortium. Non-steroidal anti-inflammatory drugs and risk of heart failure in four European countries: nested case-control study. BMJ. 2016 Sep 28;354:i4857. doi: 10.1136/bmj.i4857.
- Background: PubMed 23726390Coxib and traditional NSAID Trialists' (CNT) Collaboration; Bhala N, Emberson J, Merhi A, Abramson S, Arber N, Baron JA, Bombardier C, Cannon C, Farkouh ME, FitzGerald GA, Goss P, Halls H, Hawk E, Hawkey C, Hennekens C, Hochberg M, Holland LE, Kearney PM, Laine L, Lanas A, Lance P, Laupacis A, Oates J, Patrono C, Schnitzer TJ, Solomon S, Tugwell P, Wilson K, Wittes J, Baigent C. Vascular and upper gastrointestinal effects of non-steroidal anti-inflammatory drugs: meta-analyses of individual participant data from randomised trials. Lancet. 2013 Aug 31;382(9894):769-79. doi: 10.1016/S0140-6736(13)60900-9. Epub 2013 May 30.
- BackgroundChoosing Wisely American Society of Nephrology NSAIDs Recommendation. https://www.choosingwisely.org/clinician-lists/american-society-nephrology-nsaids-in-individuals-with-hypertension-heart-failure-or-chronic-kidney-disease/, accessed March 2022
- Background: PubMed 28674622Davis JS, Lee HY, Kim J, Advani SM, Peng HL, Banfield E, Hawk ET, Chang S, Frazier-Wood AC. Use of non-steroidal anti-inflammatory drugs in US adults: changes over time and by demographic. Open Heart. 2017 Apr 28;4(1):e000550. doi: 10.1136/openhrt-2016-000550. eCollection 2017.
- Background: PubMed 24517512Davison SN, Koncicki H, Brennan F. Pain in chronic kidney disease: a scoping review. Semin Dial. 2014 Mar;27(2):188-204. doi: 10.1111/sdi.12196. Epub 2014 Feb 12.
- BackgroundGates, B. J., Setter, S. M., Corbett, C. F., & Baker, D. E. (2005). A Comparison of Educational Methods to Improve NSAID Knowledge and Use of a Medication List in an Elderly Population. Home Health Care Management & Practice, 17(5), 403-410.
- Background: PubMed 11464731Green GA. Understanding NSAIDs: from aspirin to COX-2. Clin Cornerstone. 2001;3(5):50-60. doi: 10.1016/s1098-3597(01)90069-9.
- Background: PubMed 32600518Hales CM, Martin CB, Gu Q. Prevalence of Prescription Pain Medication Use Among Adults: United States, 2015-2018. NCHS Data Brief. 2020 Jun;(369):1-8.
- Background: PubMed 24393558Harirforoosh S, Asghar W, Jamali F. Adverse effects of nonsteroidal antiinflammatory drugs: an update of gastrointestinal, cardiovascular and renal complications. J Pharm Pharm Sci. 2013;16(5):821-47. doi: 10.18433/j3vw2f.
- Background: PubMed 24686883Koffeman AR, Valkhoff VE, Celik S, W't Jong G, Sturkenboom MC, Bindels PJ, van der Lei J, Luijsterburg PA, Bierma-Zeinstra SM. High-risk use of over-the-counter non-steroidal anti-inflammatory drugs: a population-based cross-sectional study. Br J Gen Pract. 2014 Apr;64(621):e191-8. doi: 10.3399/bjgp14X677815.
- Background: PubMed 15369888Labelle M, Beaulieu M, Paquette D, Fournier C, Bessette L, Choquette D, Rahme E, Thivierge RL. An integrated approach to improving appropriate use of anti-inflammatory medication in the treatment of osteoarthritis in Quebec (Canada): the CURATA model. Med Teach. 2004 Aug;26(5):463-70. doi: 10.1080/0142159042000218669.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michelle Rockwell, PhD, RD principal investigator
Carilion Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational video in people with Chronic Kidney Diseases and Heart Failure, run by Carilion Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Contemplation Ladder score (time frame: baseline prior to viewing VIDEO or CONTROL and within 10 minutes after viewing VIDEO or CONTROL and 4 weeks later). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06575205, which also lists 29 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2024.