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Novel Methods for Ascertainment of Gout Flares -A Pilot Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02855437
Recruitment Status : Completed
First Posted : August 4, 2016
Results First Posted : October 28, 2019
Last Update Posted : October 28, 2019
University of Nebraska
Information provided by (Responsible Party):
Kenneth Saag, MD, MSc, University of Alabama at Birmingham

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Gout Device: IVR (Phone call) Device: RheumPro (Smartphone application) Not Applicable

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priority outcome that should be examined in future comparative effectiveness studies of urate lowering therapy (ULT) (unpublished results).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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Novel Methods for Ascertainment of Gout Flares -A Pilot Study
Study Start Date : September 2016
Actual Primary Completion Date : August 2018
Actual Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Gout
MedlinePlus related topics: Gout

Arm Intervention/treatment
Active Comparator: Interactive Voice Response
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.
Device: 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.

Active Comparator: 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.
Device: 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.

Primary Outcome Measures :
  1. Preference IVR vs RheumPRO [ Time Frame: 6 months ]
    Percentage of total study population preferring IVR vs. RheumPRO

  2. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • >/= 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02855437

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United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
University of Alabama at Birmingham
University of Nebraska
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Principal Investigator: Kenneth Saag, M.D. University of Alabama at Birmingham
  Study Documents (Full-Text)

Documents provided by Kenneth Saag, MD, MSc, University of Alabama at Birmingham:

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Kenneth Saag, MD, MSc, Vice Chair, Department of Medicine; Jane Knight Lowe Professor, Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham Identifier: NCT02855437    
Other Study ID Numbers: X160105005
ESR-15-11070 ( Other Identifier: AstraZenca )
First Posted: August 4, 2016    Key Record Dates
Results First Posted: October 28, 2019
Last Update Posted: October 28, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Joint Diseases
Musculoskeletal Diseases
Crystal Arthropathies
Rheumatic Diseases
Purine-Pyrimidine Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases