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

2016-04-18 17:38:22 | BioPortfolio

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.

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 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Gout

Intervention

Improvement of Medication Adherence

Location

Birmingham VA Medical Center, Birmingham, AL
Birmingham
Alabama
United States
35233

Status

Not yet recruiting

Source

VA Office of Research and Development

Results (where available)

View Results

Links

Published on BioPortfolio: 2016-04-18T17:38:22-0400

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Medical and Biotech [MESH] Definitions

Extent to which the patient follows prescribed treatment such as keeping APPOINTMENTS AND SCHEDULES and MEDICATION ADHERENCE for desired therapeutic outcome. It implies active responsibility shared by patient and health care providers.

Voluntary cooperation of the patient in taking drugs or medicine as prescribed. This includes timing, dosage, and frequency.

Improper use of drugs or medications outside the intended purpose, scope, or guidelines for use. This is in contrast to MEDICATION ADHERENCE, and distinguished from DRUG ABUSE, which is a deliberate or willful action.

Approach to improve the quality of care by selectively encouraging or discouraging the use of specific health care services, based on their potential benefit to patients' health, relative to their cost. One element is lowering beneficiary cost sharing or out-of-pocket spending to increase medication adherence.

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