Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Gout
  • Health Related Quality of Life
  • Low Medication Adherence
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 19 years and 125 years
Gender
Both males and females

Description

The investigators will conduct a 12-month, multicenter, randomized controlled trial among 250 African-American Veterans with gout with ULT medication possession ratio of <80% at Birmingham, St. Louis and Philadelphia VA clinics. The investigators will compare the efficacy of the storytelling interve...

The investigators will conduct a 12-month, multicenter, randomized controlled trial among 250 African-American Veterans with gout with ULT medication possession ratio of <80% at Birmingham, St. Louis and Philadelphia VA clinics. The investigators will compare the efficacy of the storytelling intervention to usual care in improving Urate Lowering Therapy (ULT) adherence, assessed with MEMSCaps (electronic monitoring) at 6-months (primary outcome); reducing gout flares needing treatment, improving patient satisfaction, improving the ability to achieve target serum urate <6 mg/dl and improving self-reported ULT adherence at 6-months (secondary outcomes). The investigators will assess these outcomes at 12-months as evidence for sustenance of the effect of intervention. Alignment with VA mission and priorities: This study serves the VA's mission of improving the health of Veterans and addresses two priority areas, 1) decreasing health care disparities and 2) improving health care delivery using a low-cost, technology-based solution to poor medication adherence. Study results will lead to a ready-to-implement low cost patient-centered intervention for AA Veterans with gout to improve medication adherence and patient outcomes. This study will provide the proof of efficacy of "storytelling" for improving medication adherence in chronic symptomatic diseases. The "storytelling" intervention can be easily adapted for similar chronic symptomatic conditions such as COPD and CHF. As of 12/11/2020: completed enrollment end of September 2019, now in active 1-yr FU of people enrolled

Tracking Information

NCT #
NCT02741700
Collaborators
Not Provided
Investigators
Principal Investigator: Jasvinder A Singh, MD MPH Birmingham VA Medical Center, Birmingham, AL