- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02741700
SToRytelling to Improve DiseasE Outcomes in GOut: The STRIDE-GO2 Study (STRIDE-GO2)
STorytelling to Improve DiseasE Outcomes in GoUT: The STRIDE-GO Study
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Alabama
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Birmingham, Alabama, United States, 35233
- Birmingham VA Medical Center, Birmingham, AL
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Missouri
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Saint Louis, Missouri, United States, 63106
- St. Louis VA Medical Center John Cochran Division, St. Louis, MO
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Exclusion Criteria:
- participants who use pill-box for ULT medication use
- participants who Opt-out for the research will not be contacted
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 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.
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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.
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ACTIVE_COMPARATOR: 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.
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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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Medication Adherence
Time Frame: 3, 6, 9, and 12 months
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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)
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3, 6, 9, and 12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Gout Flares
Time Frame: 12 months
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Participant-reported total number of gout flares in the last 1 month
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12 months
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Patient Satisfaction
Time Frame: 12 months
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Patient satisfaction with medication on the patient questionnaire (SATMED composite score), range 0-100.
The SATMED-Q contains 17 items, each scored on a 5-point Likert scale.
The total composite score ranges between 0 and 68.
The score was converted to a percentage as recommended (=(raw score*100)/68); higher score = more satisfaction with medication.
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12 months
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Target Serum Urate
Time Frame: 12 months
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Serum urate with absolute value in mg/dl, as indirect measures of better ULT adherence and important gout outcomes
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12 months
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Collaborators and Investigators
Investigators
- Principal Investigator: Jasvinder A Singh, MD MPH, Birmingham VA Medical Center, Birmingham, AL
Publications and helpful links
General Publications
- 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.
- Singh 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.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IIR 13-314
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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