N/A
N=44
Novel Methods for Ascertainment of Gout Flares -A Pilot Study
Gout
Bottom Line
View on ClinicalTrials.gov: NCT02855437 ↗Enrolled (actual)
44
Serious AEs
—
Results posted
Oct 2019
Primary outcome: Primary: Preference IVR vs RheumPRO — 3; 28 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- IVR (Phone call) (Device); RheumPro (Smartphone application) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Alabama at Birmingham
- Primary completion
- Aug 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Preference IVR vs RheumPRO |
3; 28 | — |
| PRIMARY Feasibility of Using IVR vs. RheumPRO to Report Gout Flares |
81; 80 | — |
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.
Eligibility Criteria
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).
Data sourced from ClinicalTrials.gov (NCT02855437). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.