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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

306 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-31

Study Completion Date

2021-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Natural Language Processing and Quality Assessment in Primary Care

NCT01023243

Diabetes

COMPLETED NA

Comparison of Outreach Approaches to Increase Enrollment in a Healthy Cholesterol Study

NCT02086539

Diabetes

COMPLETED NA

Patient Navigator PRE-ACT Educational Intervention to Promote Decision Making Among Minorities

NCT05701085

Educational Intervention Minorities

RECRUITING NA

Trial of Strategies to Communicate Genetic Information to Different Ethnic Subpopulations

NCT03023735

Communication

UNKNOWN

Community Engagement for Early Recognition and Immediate Action in Stroke

NCT02301299

Ischemic Stroke

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Gout Low Medication Adherence Health Related Quality of Life

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Gout storytelling video

Participants view culturally relevant patient narrated storytelling in African-American Veterans' own voices about their experience with gout and its treatment and a patient narrated slide show of gout and its treatment.

Group Type EXPERIMENTAL

Gout Storytelling Video Intervention

Intervention Type BEHAVIORAL

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.

Video about management of another chronic condition

Participants view a patient narrated slide show of roughly the same duration as the experimental arm, summarizing the management of stress, a non-gout chronic condition.

Group Type ACTIVE_COMPARATOR

Gout Storytelling Video Intervention

Intervention Type BEHAVIORAL

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* African American Veteran Patients with Gout currently on urate-lowering therapy (ULT; most commonly allopurinol) with either low ULT adherence, defined as an average medication possession ration (MPR) \<0.80 or MPR \>=0.80