Novel Methods for Ascertainment of Gout Flares -A Pilot Study

NACompletedINTERVENTIONAL
Enrollment

44

Participants

Timeline

Start Date

September 30, 2016

Primary Completion Date

August 31, 2018

Study Completion Date

August 31, 2018

Conditions
Gout
Interventions
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.

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."

Trial Locations (1)

35294

University of Alabama at Birmingham, Birmingham

All Listed Sponsors
collaborator

University of Nebraska

OTHER

lead

University of Alabama at Birmingham

OTHER

NCT02855437 - Novel Methods for Ascertainment of Gout Flares -A Pilot Study | Biotech Hunter | Biotech Hunter