GoutNCT02855437
Novel Methods for Ascertainment of Gout Flares -A Pilot Study
A study testing IVR (Phone call) and RheumPro (Smartphone application) in people with Gout, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
The purpose of this study is to determine the feasibility and acceptability of using different remote data collection technologies to ascertain flare occurrence among gout patients. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gout
- What is being tested?
- IVR (Phone call) and RheumPro (Smartphone application)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2016to Aug 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- >/= to 18 yrs of age with Current physician diagnosed gout
- current hyperuricemia (serum urate level >6.8 mg/dl)
- self-report of at least two gout flares in the previous 6 months
- current smartphone user utilizing a FitBit compatible smart Phone (with the ability to download RheumPRO from Apple/Google Play store).
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294
About this study
The purpose of this study is to determine the feasibility and acceptability of using different remote data collection technologies to ascertain flare occurrence among gout patients. Two technologies will be the focus of this study: a telephone based interactive voice response (IVR) and a smartphone mobile application (called RheumPRO). The results of this study will not only guide research approaches in clinical trials, but may also have direct implications for monitoring patient outcomes in the context of day-to-day clinical practice.
The investigators hypothesize that acceptability will be greater for RheumPRO application than IVR. Additionally, the investigators hypothesize that RheumPRO will be associated with a greater frequency of patient-initiated interactions.
Read the detailed description
Acute gout flares are a major cause of morbidity. Flares lead to substantial reductions in health-related quality of life, increased work absenteeism, productivity loss, and substantial healthcare costs. Acute gout flares are likely related to more than 174,000 emergency department visits in the U.S. annually with corresponding charges approaching $166 million.
In recent surveys, gout patients and healthcare providers alike identified the reduction of gout flares as the highest priority outcome that should be examined in future comparative effectiveness studies of urate lowering therapy (ULT) (unpublished results). Despite consensus about the importance of capturing flares, clinical trials investigating ULTs or anti-inflammatory prophylaxis have used inconsistent flare definitions and methods of flare ascertainment. The inconsistency has likely been driven by the absence of a standardized definition or ascertainment method. These deficits limit comparisons that can be made across investigations.
Recently, a group supported by the American College of Rheumatology \& European League Against Rheumatism (ACR \& EULAR) has attempted to define a gout flare (8-10). For simplicity, the group focused on defining only those flares occurring after a definitive gout diagnosis. Nine elements of a flare definition emerged from the first two studies. These nine elements included physician reported information, laboratory data and patient self-report. In a third study, Gaffo et al. compared the discriminatory ability of the self-reported items against the gold standard of a rheumatologist's judgment of flare presence. Self-report of 4 criteria had the greatest discriminatory ability with an area under the curve (AUC) of 0.931. These promising results indicate the important role for a standardized self-report definition of a gout flare.
In addition to variability in gout flare definitions, the optimal method for obtaining self-reported flares remains undefined. An early study of febuxostat, for example, assessed flares weekly at physician visits Another study counted a flare only when it was treated by a healthcare provider. Still other studies assessed flares during physician visits occurring at variable time points. These inconsistent methods also pose practical limitations given by their time and resource intensive nature. Opportunities to increase efficiency have only recently become available with the validation of the self-reported definition for gout flares described above. Self-report can now be combined with technological advances in remote data collection to develop novel and highly efficient methods to identify gout flares. The investigators propose a study to address this pressing need by leveraging technological advances that facilitate the remote and real-time collection of patient reported flares and outcomes (PROs) in gout.
- Conditions
- Gout
- Being tested
- IVR (Phone call), RheumPro (Smartphone application)
- Medical subject headings
- Gout
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IVR (Phone call)Device
IVR will auto dial participants at a schedule time. Participants complete questions using their phone keypad. Participants can also call the IVR to complete surveys if they experience a flare. The IVR will be programmed to call the patient weekly for 26 weeks to complete a weekly Gout Flare Survey and Patient Reported Outcomes Survey. Consistent with the published gout flare self-report definition, gout flare ascertainment questions will include whether the recent flare is similar to past flares, the number of swollen joints and the number of warm joints. Pain at rest during the attack will be assessed on a 0-9 scale. Further questions will include peak pain, timing of attack and duration of attack if completed. We will capture patient reported outcome measures (e.g. pain, fatigue, sleep) using instruments from NIH PROMIS. Following completion of 26 week IVR period participants will crossover to RheumPro arm.
RheumPro (Smartphone application)Device
RheumPRO will be programmed to notify participants weekly for 26 weeks via a scheduled "pop-up" to complete Gout Flare and Patient Reported Outcomes Surveys. Participants self-navigate through the survey questions using their smartphone. If participants do not complete the Gout Flare or Patient Reported Outcomes surveys RheumPro will generate 2 more "pop-ups" at the same time over the proceeding 2 days (eg. Tuesday 4 PM, Wednesday 4 PM). Participants can also open the RheumPro application on their smartphone and complete surveys or if they experience a flare on a day they are not scheduled to complete a survey. Following completion of 26 week RheumPro period participants will crossover to IVR arm.
| Study group | Role | What they receive |
|---|---|---|
| Interactive Voice Response | Active comparator | The interactive voice response system (IVR) is an automated telephone system that is used to contact study participants. At enrollment the study coordinator will explain how the IVR works, planned survey schedule, and that participant -initiated calls to IVR are allowed. Receives: Device: IVR (Phone call) |
| RheumPro Smartphone Application | Active comparator | RheumPro is a UAB developed smartphone application to capture patient reported outcomes. At enrollment the study coordinator will explain how RheumPro works, planned survey schedule, and that participant -initiated surveys in RheumPro are allowed. Receives: Device: RheumPro (Smartphone application) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preference IVR vs RheumPRO
Percentage of total study population preferring IVR vs. RheumPRO
Measured: 6 months
Feasibility of Using IVR vs. RheumPRO to Report Gout Flares
Feasibility ----Assessed by the percentage of participants completing answer IRV/RheumPRO queries.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2016 (estimated)
- Study startSep 2016
- Primary completionAug 2018
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for GoutStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- University of Nebraska
- Responsible party
- Principal investigator, Kenneth Saag, MD, MSc, University of Alabama at Birmingham
- Investigators
- Kenneth Saag, M.D., Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02855437
- Sponsor's protocol ID
- X160105005
- Other IDs
- ESR-15-11070
- Status last verified
- Oct 2019
- First submitted
- 28 Jul 2016
- Last updated
- 28 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Garg R, Sayles HR, Yu F, Michaud K, Singh J, Saag KG, Mikuls TR. Gout-related health care utilization in US emergency departments, 2006 through 2008. Arthritis Care Res (Hoboken). 2013 Apr;65(4):571-7. doi: 10.1002/acr.21837.
PubMed 22949176Becker MA, Schumacher HR Jr, Wortmann RL, MacDonald PA, Palo WA, Eustace D, Vernillet L, Joseph-Ridge N. Febuxostat, a novel nonpurine selective inhibitor of xanthine oxidase: a twenty-eight-day, multicenter, phase II, randomized, double-blind, placebo-controlled, dose-response clinical trial examining safety and efficacy in patients with gout. Arthritis Rheum. 2005 Mar;52(3):916-23. doi: 10.1002/art.20935.
PubMed 15751090Becker MA, Schumacher HR Jr, Wortmann RL, MacDonald PA, Eustace D, Palo WA, Streit J, Joseph-Ridge N. Febuxostat compared with allopurinol in patients with hyperuricemia and gout. N Engl J Med. 2005 Dec 8;353(23):2450-61. doi: 10.1056/NEJMoa050373.
PubMed 16339094Schumacher HR Jr, Becker MA, Wortmann RL, Macdonald PA, Hunt B, Streit J, Lademacher C, Joseph-Ridge N. Effects of febuxostat versus allopurinol and placebo in reducing serum urate in subjects with hyperuricemia and gout: a 28-week, phase III, randomized, double-blind, parallel-group trial. Arthritis Rheum. 2008 Nov 15;59(11):1540-8. doi: 10.1002/art.24209.
PubMed 18975369Becker MA, Schumacher HR, Espinoza LR, Wells AF, MacDonald P, Lloyd E, Lademacher C. The urate-lowering efficacy and safety of febuxostat in the treatment of the hyperuricemia of gout: the CONFIRMS trial. Arthritis Res Ther. 2010;12(2):R63. doi: 10.1186/ar2978. Epub 2010 Apr 6.
PubMed 20370912Sundy JS, Baraf HS, Yood RA, Edwards NL, Gutierrez-Urena SR, Treadwell EL, Vazquez-Mellado J, White WB, Lipsky PE, Horowitz Z, Huang W, Maroli AN, Waltrip RW 2nd, Hamburger SA, Becker MA. Efficacy and tolerability of pegloticase for the treatment of chronic gout in patients refractory to conventional treatment: two randomized controlled trials. JAMA. 2011 Aug 17;306(7):711-20. doi: 10.1001/jama.2011.1169.
PubMed 21846852Borstad GC, Bryant LR, Abel MP, Scroggie DA, Harris MD, Alloway JA. Colchicine for prophylaxis of acute flares when initiating allopurinol for chronic gouty arthritis. J Rheumatol. 2004 Dec;31(12):2429-32.
PubMed 15570646Taylor WJ, Schumacher HR Jr, Baraf HS, Chapman P, Stamp L, Doherty M, McQueen F, Dalbeth N, Schlesinger N, Furst DE, Vazquez-Mellado J, Becker MA, Kavanaugh A, Louthrenoo W, Bardin T, Khanna D, Simon LS, Yamanaka H, Choi HK, Zeng X, Strand V, Grainger R, Clegg D, Singh JA, Diaz-Torne C, Boers M, Gow P, Barskova VG. A modified Delphi exercise to determine the extent of consensus with OMERACT outcome domains for studies of acute and chronic gout. Ann Rheum Dis. 2008 Jun;67(6):888-91. doi: 10.1136/ard.2007.079970. Epub 2007 Nov 29.
PubMed 18055475Taylor WJ, Shewchuk R, Saag KG, Schumacher HR Jr, Singh JA, Grainger R, Edwards NL, Bardin T, Waltrip RW, Simon LS, Burgos-Vargas R. Toward a valid definition of gout flare: results of consensus exercises using Delphi methodology and cognitive mapping. Arthritis Rheum. 2009 Apr 15;61(4):535-43. doi: 10.1002/art.24166.
PubMed 19333981Gaffo AL, Schumacher HR, Saag KG, Taylor WJ, Dinnella J, Outman R, Chen L, Dalbeth N, Sivera F, Vazquez-Mellado J, Chou CT, Zeng X, Perez-Ruiz F, Kowalski SC, Goldenstein-Schainberg C, Chen L, Bardin T, Singh JA. Developing a provisional definition of flare in patients with established gout. Arthritis Rheum. 2012 May;64(5):1508-17. doi: 10.1002/art.33483.
PubMed 22083456Elmagboul N, Coburn BW, Foster J, Mudano A, Melnick J, Bergman D, Yang S, Chen L, Filby C, Mikuls TR, Curtis JR, Saag K. Physical activity measured using wearable activity tracking devices associated with gout flares. Arthritis Res Ther. 2020 Aug 3;22(1):181. doi: 10.1186/s13075-020-02272-2.
PubMed 32746893Elmagboul N, Coburn BW, Foster J, Mudano A, Melnick J, Bergman D, Yang S, Redden D, Chen L, Filby C, Curtis JR, Mikuls TR, Saag KG. Comparison of an interactive voice response system and smartphone application in the identification of gout flares. Arthritis Res Ther. 2019 Jun 29;21(1):160. doi: 10.1186/s13075-019-1944-5.
PubMed 31255174
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Methods for Ascertainment of Gout Flares -A Pilot Study
- ClinicalTrials.gov ID
- NCT02855437
- Acronym / sponsor ID
- X160105005
- Conditions
- Gout
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- University of Nebraska
- Study start
- Sep 2016
- Primary completion
- Aug 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 4 Aug 2016 (estimated)
- Results
- Posted 28 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the feasibility and acceptability of using different remote data collection technologies to ascertain flare occurrence among gout patients. Two technologies will be the focus of this study: a telephone based interactive voice response (IVR) and a smartphone mobile application (called RheumPRO). The results of this study will not only guide research approaches in clinical trials, but may also have direct implications for monitoring patient outcomes in the context of day-to-day clinical practice.
The investigators hypothesize that acceptability will be greater for RheumPRO application than IVR. Additionally, the investigators hypothesize that RheumPRO will be associated with a greater frequency of patient-initiated interactions.
Detailed description
Acute gout flares are a major cause of morbidity. Flares lead to substantial reductions in health-related quality of life, increased work absenteeism, productivity loss, and substantial healthcare costs. Acute gout flares are likely related to more than 174,000 emergency department visits in the U.S. annually with corresponding charges approaching $166 million.
In recent surveys, gout patients and healthcare providers alike identified the reduction of gout flares as the highest priority outcome that should be examined in future comparative effectiveness studies of urate lowering therapy (ULT) (unpublished results). Despite consensus about the importance of capturing flares, clinical trials investigating ULTs or anti-inflammatory prophylaxis have used inconsistent flare definitions and methods of flare ascertainment. The inconsistency has likely been driven by the absence of a standardized definition or ascertainment method. These deficits limit comparisons that can be made across investigations.
Recently, a group supported by the American College of Rheumatology \& European League Against Rheumatism (ACR \& EULAR) has attempted to define a gout flare (8-10). For simplicity, the group focused on defining only those flares occurring after a definitive gout diagnosis. Nine elements of a flare definition emerged from the first two studies. These nine elements included physician reported information, laboratory data and patient self-report. In a third study, Gaffo et al. compared the discriminatory ability of the self-reported items against the gold standard of a rheumatologist's judgment of flare presence. Self-report of 4 criteria had the greatest discriminatory ability with an area under the curve (AUC) of 0.931. These promising results indicate the important role for a standardized self-report definition of a gout flare.
In addition to variability in gout flare definitions, the optimal method for obtaining self-reported flares remains undefined. An early study of febuxostat, for example, assessed flares weekly at physician visits Another study counted a flare only when it was treated by a healthcare provider. Still other studies assessed flares during physician visits occurring at variable time points. These inconsistent methods also pose practical limitations given by their time and resource intensive nature. Opportunities to increase efficiency have only recently become available with the validation of the self-reported definition for gout flares described above. Self-report can now be combined with technological advances in remote data collection to develop novel and highly efficient methods to identify gout flares. The investigators propose a study to address this pressing need by leveraging technological advances that facilitate the remote and real-time collection of patient reported flares and outcomes (PROs) in gout.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interactive Voice Response | Active comparator | Device: IVR (Phone call)The interactive voice response system (IVR) is an automated telephone system that is used to contact study participants. At enrollment the study coordinator will explain how the IVR works, planned survey schedule, and that participant -initiated calls to IVR are allowed. |
| RheumPro Smartphone Application | Active comparator | Device: RheumPro (Smartphone application)RheumPro is a UAB developed smartphone application to capture patient reported outcomes. At enrollment the study coordinator will explain how RheumPro works, planned survey schedule, and that participant -initiated surveys in RheumPro are allowed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- >/= to 18 yrs of age with Current physician diagnosed gout
- current hyperuricemia (serum urate level >6.8 mg/dl)
- self-report of at least two gout flares in the previous 6 months
- current smartphone user utilizing a FitBit compatible smart Phone (with the ability to download RheumPRO from Apple/Google Play store).
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| IVR (Phone call)IVR will auto dial participants at a schedule time. Participants complete questions using their phone keypad. Participants can also call the IVR to complete surveys if they experience a flare. The IVR will be programmed to call the patient weekly for 26 weeks to complete a weekly Gout Flare Survey and Patient Reported Outcomes Survey. Consistent with the published gout flare self-report definition, gout flare ascertainment questions will include whether the recent flare is similar to past flares, the number of swollen joints and the number of warm joints. Pain at rest during the attack will be assessed on a 0-9 scale. Further questions will include peak pain, timing of attack and duration of attack if completed. We will capture patient reported outcome measures (e.g. pain, fatigue, sleep) using instruments from NIH PROMIS. Following completion of 26 week IVR period participants will crossover to RheumPro arm. | Device | Interactive Voice Response |
| RheumPro (Smartphone application)RheumPRO will be programmed to notify participants weekly for 26 weeks via a scheduled "pop-up" to complete Gout Flare and Patient Reported Outcomes Surveys. Participants self-navigate through the survey questions using their smartphone. If participants do not complete the Gout Flare or Patient Reported Outcomes surveys RheumPro will generate 2 more "pop-ups" at the same time over the proceeding 2 days (eg. Tuesday 4 PM, Wednesday 4 PM). Participants can also open the RheumPro application on their smartphone and complete surveys or if they experience a flare on a day they are not scheduled to complete a survey. Following completion of 26 week RheumPro period participants will crossover to IVR arm. | Device | RheumPro Smartphone Application |
Primary outcome
Preference IVR vs RheumPRO
Time frame: 6 months
Percentage of total study population preferring IVR vs. RheumPRO
Feasibility of Using IVR vs. RheumPRO to Report Gout Flares
Time frame: 6 months
Feasibility ----Assessed by the percentage of participants completing answer IRV/RheumPRO queries.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 22949176Garg R, Sayles HR, Yu F, Michaud K, Singh J, Saag KG, Mikuls TR. Gout-related health care utilization in US emergency departments, 2006 through 2008. Arthritis Care Res (Hoboken). 2013 Apr;65(4):571-7. doi: 10.1002/acr.21837.
- Background: PubMed 15751090Becker MA, Schumacher HR Jr, Wortmann RL, MacDonald PA, Palo WA, Eustace D, Vernillet L, Joseph-Ridge N. Febuxostat, a novel nonpurine selective inhibitor of xanthine oxidase: a twenty-eight-day, multicenter, phase II, randomized, double-blind, placebo-controlled, dose-response clinical trial examining safety and efficacy in patients with gout. Arthritis Rheum. 2005 Mar;52(3):916-23. doi: 10.1002/art.20935.
- Background: PubMed 16339094Becker MA, Schumacher HR Jr, Wortmann RL, MacDonald PA, Eustace D, Palo WA, Streit J, Joseph-Ridge N. Febuxostat compared with allopurinol in patients with hyperuricemia and gout. N Engl J Med. 2005 Dec 8;353(23):2450-61. doi: 10.1056/NEJMoa050373.
- Background: PubMed 18975369Schumacher HR Jr, Becker MA, Wortmann RL, Macdonald PA, Hunt B, Streit J, Lademacher C, Joseph-Ridge N. Effects of febuxostat versus allopurinol and placebo in reducing serum urate in subjects with hyperuricemia and gout: a 28-week, phase III, randomized, double-blind, parallel-group trial. Arthritis Rheum. 2008 Nov 15;59(11):1540-8. doi: 10.1002/art.24209.
- Background: PubMed 20370912Becker MA, Schumacher HR, Espinoza LR, Wells AF, MacDonald P, Lloyd E, Lademacher C. The urate-lowering efficacy and safety of febuxostat in the treatment of the hyperuricemia of gout: the CONFIRMS trial. Arthritis Res Ther. 2010;12(2):R63. doi: 10.1186/ar2978. Epub 2010 Apr 6.
- Background: PubMed 21846852Sundy JS, Baraf HS, Yood RA, Edwards NL, Gutierrez-Urena SR, Treadwell EL, Vazquez-Mellado J, White WB, Lipsky PE, Horowitz Z, Huang W, Maroli AN, Waltrip RW 2nd, Hamburger SA, Becker MA. Efficacy and tolerability of pegloticase for the treatment of chronic gout in patients refractory to conventional treatment: two randomized controlled trials. JAMA. 2011 Aug 17;306(7):711-20. doi: 10.1001/jama.2011.1169.
- Background: PubMed 15570646Borstad GC, Bryant LR, Abel MP, Scroggie DA, Harris MD, Alloway JA. Colchicine for prophylaxis of acute flares when initiating allopurinol for chronic gouty arthritis. J Rheumatol. 2004 Dec;31(12):2429-32.
- Background: PubMed 18055475Taylor WJ, Schumacher HR Jr, Baraf HS, Chapman P, Stamp L, Doherty M, McQueen F, Dalbeth N, Schlesinger N, Furst DE, Vazquez-Mellado J, Becker MA, Kavanaugh A, Louthrenoo W, Bardin T, Khanna D, Simon LS, Yamanaka H, Choi HK, Zeng X, Strand V, Grainger R, Clegg D, Singh JA, Diaz-Torne C, Boers M, Gow P, Barskova VG. A modified Delphi exercise to determine the extent of consensus with OMERACT outcome domains for studies of acute and chronic gout. Ann Rheum Dis. 2008 Jun;67(6):888-91. doi: 10.1136/ard.2007.079970. Epub 2007 Nov 29.
- Background: PubMed 19333981Taylor WJ, Shewchuk R, Saag KG, Schumacher HR Jr, Singh JA, Grainger R, Edwards NL, Bardin T, Waltrip RW, Simon LS, Burgos-Vargas R. Toward a valid definition of gout flare: results of consensus exercises using Delphi methodology and cognitive mapping. Arthritis Rheum. 2009 Apr 15;61(4):535-43. doi: 10.1002/art.24166.
- Background: PubMed 22083456Gaffo AL, Schumacher HR, Saag KG, Taylor WJ, Dinnella J, Outman R, Chen L, Dalbeth N, Sivera F, Vazquez-Mellado J, Chou CT, Zeng X, Perez-Ruiz F, Kowalski SC, Goldenstein-Schainberg C, Chen L, Bardin T, Singh JA. Developing a provisional definition of flare in patients with established gout. Arthritis Rheum. 2012 May;64(5):1508-17. doi: 10.1002/art.33483.
- Derived from this study: PubMed 32746893Elmagboul N, Coburn BW, Foster J, Mudano A, Melnick J, Bergman D, Yang S, Chen L, Filby C, Mikuls TR, Curtis JR, Saag K. Physical activity measured using wearable activity tracking devices associated with gout flares. Arthritis Res Ther. 2020 Aug 3;22(1):181. doi: 10.1186/s13075-020-02272-2.
- Derived from this study: PubMed 31255174Elmagboul N, Coburn BW, Foster J, Mudano A, Melnick J, Bergman D, Yang S, Redden D, Chen L, Filby C, Curtis JR, Mikuls TR, Saag KG. Comparison of an interactive voice response system and smartphone application in the identification of gout flares. Arthritis Res Ther. 2019 Jun 29;21(1):160. doi: 10.1186/s13075-019-1944-5.
- Individual participant dataSharing planned: No
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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.
Kenneth Saag, M.D. principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IVR (Phone call) and RheumPro (Smartphone application) in people with Gout, run by University of Alabama at Birmingham 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 4 inclusion and 0 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: finished, as of the sponsor's last update on 28 Oct 2019. 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?
Yes. Results are posted in the registry (first posted 28 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Preference IVR vs RheumPRO (time frame: 6 months). 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 NCT02855437, which also lists 12 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 28 Oct 2019; AzTrials last refreshed its copy on 6 Nov 2026.