Clinical Trial: SToRytelling to Improve DiseasE Outcomes in GOut: The STRIDE-GO 2 Study

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: STorytelling to Improve DiseasE Outcomes in GoUT: The STRIDE-GO Study

Brief Summary: The objective is to test the efficacy of a patient-centered, culturally relevant narrative intervention, or "storytelling," based on the solid conceptual foundation of the narrative communication theory and the constructs of the Health Belief Model (HBM) to improve medication adherence and outcomes in chronic diseases among African-Americans (AA), using gout as an example. Gout is a chronic disease associated with chronic symptoms and disability interrupted by intermittent acute flares, similar to Chronic Obstructive Pulmonary Disease (COPD) and Congestive Heart Failure (CHF) that leads to joint destruction if not treated appropriately. Due to the intermittently symptomatic nature of chronic conditions, patients often don't perceive disease severity and susceptibility to disease complications, and, therefore, may not balance the barriers and benefits to medication adherence. Storytelling in the patients' own voices has the power to directly and more effectively confront a patient's barriers to medication adherence, reinforce the benefits and provide useful cues to action. Storytelling promotes patient engagement when the patient identifies with the storyteller and can lead to a patient's recognition of the need to treat the condition and improve health outcomes, as shown by a meaningful improvement in blood pressure in a recent clinical trial in AAs with hypertension. The success of this project, combined with other published data, will represent a major step toward demonstrating the effectiveness of storytelling to improve medication adherence in chronic diseases and will address two VA research priority areas, i.e., health care disparities and health care delivery.

Detailed Summary:

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.


Sponsor: VA Office of Research and Development

Current Primary Outcome: Medication Adherence [ Time Frame: 12 months ]

ULT adherence, directly measured by using MEMS (Medication Event Monitoring System) Caps at 3, 6 and 9 months (assess intervention?s effect) and 12 months (assess durability of effect),


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Gout flare rate [ Time Frame: 12 months ]
    Gout flare rate assessed by the 2012 Gout Flare Definition
  • Patient Satisfaction [ Time Frame: 12 months ]
    Patient satisfaction on patient questionnaire
  • Target Serum Urate [ Time Frame: 12 months ]
    Target serum urate (sUA) <6 mg/dl achievement, as indirect measures of better ULT adherence and important gout outcomes


Original Secondary Outcome: Same as current

Information By: VA Office of Research and Development

Dates:
Date Received: March 21, 2016
Date Started: May 2017
Date Completion: August 2020
Last Updated: January 30, 2017
Last Verified: January 2017