NCT02741700

SToRytelling to Improve DiseasE Outcomes in GOut: The STRIDE-GO2 Study

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 306 (actual)
• Sponsor: VA Office of Research and Development · Federal
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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 description

The investigators will conduct a 12-month, multicenter, randomized controlled trial among 250 African-American Veterans with gout with a 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 the sustenance of the effect of the 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 proof of the 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.

Conditions

• Gout
• Low Medication Adherence
• Health Related Quality of Life

Interventions

Type	Name	Description
BEHAVIORAL	Gout Storytelling Video Intervention	The investigators developed a storytelling intervention for African-Americans with gout, to address barriers to optimal gout management and provide cues for better disease management, which were narrated by several Veterans with gout. One of the veterans also presented a PowerPoint on gout and its management. The intervention was shown to the participants on a touchscreen computer or the desktop screen at the baseline study visit. Subsequently, they were provided with DVD with similar intervention to watch at home.

Timeline

• Start date: 2017-05-31
• Primary completion: 2020-12-31
• Completion: 2021-08-31
• First posted: 2016-04-18
• Last updated: 2022-03-17
• Results posted: 2022-02-23

Locations

3 sites across 1 country: United States