Trial Outcomes & Findings for Novel Methods for Ascertainment of Gout Flares -A Pilot Study (NCT NCT02855437)

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 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.

n=44 Participants

Overall description of participants in the pilot study entitled, "Novel Methods for Ascertainment of Gout Flares -A Pilot Study"

n=38 Participants

The interactive voice response system (IVR) is an automated telephone system that is used to contact participants. At enrollment the study coordinator will explain how the IVR works, planned survey schedule, and that participant -initiated calls to IVR are allowed. 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

n=38 Participants

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. 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. In addition RheumPro questionnaires at months 1 , 3, and 6 will assess RheumPro ease of use.

n=38 Participants

The interactive voice response system (IVR) is an automated telephone system that is used to contact participants. At enrollment the study coordinator will explain how the IVR works, planned survey schedule, and that participant -initiated calls to IVR are allowed. 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

n=38 Participants

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. 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. In addition RheumPro questionnaires at months 1 , 3, and 6 will assess RheumPro ease of use.