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

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


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.


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




Improvement of Medication Adherence


Birmingham VA Medical Center, Birmingham, AL
United States


Not yet recruiting


VA Office of Research and Development

Results (where available)

View Results


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

Clinical Trials [1267 Associated Clinical Trials listed on BioPortfolio]

Denosumab In Addition To Intense Urate-Lowering Therapy for Bone Erosions

Bone erosions are a common manifestation and feature of structural damage in severe/chronic tophaceous gout. Management of this destructive and often debilitating gout complication has foc...

The Impact of GlowCaps Connect™ and Its Services on Hypertension Medication Adherence

The investigators hypothesize that providing subjects on a once-a-day hypertension medication with GlowCaps ConnectTM will lead to an improvement in their medication adherence. The investi...

Optimal Administration of Allopurinol in Dialysis Patients

Gout has a strong association with the metabolic syndrome, and it is often seen in patients with renal insufficiency. Allopurinol is a medication intended to lower uric acid and therefore ...

Study of the Safety and Effectiveness of Rilonacept for the Prevention of Gout Flares

This is a clinical research study to determine the safety and effectiveness of an experimental drug called rilonacept in subjects with gout who are beginning another additional treatment. ...

Assessment of Primary Care Providers' Knowledge and Beliefs Regarding Gout Management

This is a questionnaire study aimed at learning about physicians' views on the treatment of Gout.

PubMed Articles [5175 Associated PubMed Articles listed on BioPortfolio]

Non-adherence to psychotropic medication assessed by plasma levels in newly admitted psychiatric patients.

Non-adherence or partial adherence to psychotropic medication is found in 18-70% of patients. However, many previously used methods for the assessment of adherence (e.g., questionnaires, pill counts, ...

Determinants of suboptimal medication adherence in patients with a major depressive episode.

Major Depression (MD) is often a chronic condition requiring a long-term pharmacologic treatment. Despite the efficacy of antidepressants, the medication adherence in those affected is usually very po...

Clusters of non-adherence to medication in neurological patients.

Non-adherence to medication is a common and serious problem in health care. To develop more effective interventions to improve adherence, there is a need for a better understanding of the individual t...

Assessment of Patient Medication Adherence, Medical Record Accuracy, and Medication Blood Concentrations for Prescription and Over-the-Counter Medications.

Inaccurate medication records and poor medication adherence result in incomplete knowledge of therapy for patients.

Temporal effectiveness of interventions to improve medication adherence: A network meta-analysis.

Adherence-enhancing interventions have been assessed in the literature, however heterogeneity and conflicting findings have prohibited a consensus on the most effective approach to maintain adherence ...

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.

Agents that increase uric acid excretion by the kidney (URICOSURIC AGENTS), decrease uric acid production (antihyperuricemics), or alleviate the pain and inflammation of acute attacks of gout.

More From BioPortfolio on "SToRytelling to Improve DiseasE Outcomes in GOut: The STRIDE-GO 2 Study"

Quick Search


Relevant Topics

Pharmacy is the science and technique of preparing as well as dispensing drugs and medicines. It is a health profession that links health sciences with chemical sciences and aims to ensure the safe and effective use of pharmaceutical drugs. The scope of...

Arthritis Fibromyalgia Gout Lupus Rheumatic Rheumatology is the medical specialty concerned with the diagnosis and management of disease involving joints, tendons, muscles, ligaments and associated structures (Oxford Medical Diction...

Searches Linking to this Trial