SToRytelling to Improve DiseasE Outcomes in GOut: The STRIDE-GO2 Study
STRIDE-GO2
STorytelling to Improve DiseasE Outcomes in GoUT: The STRIDE-GO Study
1 other identifier
interventional
306
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2017
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 21, 2016
CompletedFirst Posted
Study publicly available on registry
April 18, 2016
CompletedStudy Start
First participant enrolled
May 31, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2021
CompletedResults Posted
Study results publicly available
February 23, 2022
CompletedMarch 17, 2022
March 1, 2022
3.6 years
March 21, 2016
December 7, 2021
March 8, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Medication Adherence
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 the durability of effect)
3, 6, 9, and 12 months
Secondary Outcomes (3)
Gout Flares
12 months
Patient Satisfaction
12 months
Target Serum Urate
12 months
Study Arms (2)
Gout storytelling video
EXPERIMENTALParticipants 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.
Video about management of another chronic condition
ACTIVE COMPARATORParticipants 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- participants who use pill-box for ULT medication use
- participants who Opt-out for the research will not be contacted
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Birmingham VA Medical Center, Birmingham, AL
Birmingham, Alabama, 35233, United States
St. Louis VA Medical Center John Cochran Division, St. Louis, MO
St Louis, Missouri, 63106, United States
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
Philadelphia, Pennsylvania, 19104, United States
Related Publications (2)
Singh JA. SToRytelliing to Improve Disease outcomes in Gout (STRIDE-GO) in African American veterans with gout: a trial study protocol. Trials. 2021 Dec 4;22(1):879. doi: 10.1186/s13063-021-05847-9.
PMID: 34863255DERIVEDSingh JA, Joseph A, Baker J, Richman JS, Shaneyfelt T, Saag KG, Eisen S. SToRytelling to Improve Disease outcomes in Gout (STRIDE-GO): a multicenter, randomized controlled trial in African American veterans with gout. BMC Med. 2021 Nov 9;19(1):265. doi: 10.1186/s12916-021-02135-w.
PMID: 34749717DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Jasvinder Singh
- Organization
- VA ORD: Birmingham VA Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Jasvinder A Singh, MD MPH
Birmingham VA Medical Center, Birmingham, AL
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 21, 2016
First Posted
April 18, 2016
Study Start
May 31, 2017
Primary Completion
December 31, 2020
Study Completion
August 31, 2021
Last Updated
March 17, 2022
Results First Posted
February 23, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will not share
Data are owned by the VA. only with the conditions and approvals from appropriate VA authorities, we are willing to share de-identified data with requesters.