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NCT02741700: STRIDE-GO2

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

Completed NA Results posted Last updated 17 March 2022
What this trial tests

NA trial testing Gout Storytelling Video Intervention in Gout in 306 participants. Completed in 31 August 2021.

Timeline
31 May 2017
Primary endpoint
31 December 2020
31 August 2021

Quick facts

Lead sponsorVA Office of Research and Development
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment306
Start date31 May 2017
Primary completion31 December 2020
Estimated completion31 August 2021
Sites3 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

VA Office of Research and Development — full company profile →

Who can join

19 and older, any sex, with Gout or Low Medication Adherence. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Medication Adherence Primary · 3, 6, 9, and 12 months

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)

MEMSCap™ ULT MPR at 3-months
GroupValue95% CI
Gout Storytelling Video72.6167.88 – 77.35
Video About Management of Another Chronic Condition70.1265.49 – 74.75
MEMSCap™ ULT MPR at 6-months
GroupValue95% CI
Gout Storytelling Video68.5263.40 – 73.64
Video About Management of Another Chronic Condition69.3364.36 – 74.30
MEMSCap™ ULT MPR at 9-months
GroupValue95% CI
Gout Storytelling Video65.8560.14 – 71.55
Video About Management of Another Chronic Condition67.3261.84 – 72.80
MEMSCap™ ULT MPR at 12-months
GroupValue95% CI
Gout Storytelling Video60.5454.29 – 66.79
Video About Management of Another Chronic Condition63.8257.83 – 69.82
Gout Flares Secondary · 12 months

Participant-reported total number of gout flares in the last 1 month

GroupValue95% CI
Gout Storytelling Video0.740.45 – 1.02
Video About Management of Another Chronic Condition0.990.72 – 1.26
Patient Satisfaction Secondary · 12 months

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.

GroupValue95% CI
Gout Storytelling Video62.1657.09 – 67.23
Video About Management of Another Chronic Condition67.4362.39 – 72.47
Target Serum Urate Secondary · 12 months

Serum urate with absolute value in mg/dl, as indirect measures of better ULT adherence and important gout outcomes

GroupValue95% CI
Gout Storytelling Video5.945.61 – 6.27
Video About Management of Another Chronic Condition5.725.41 – 6.04

Adverse events — posted to ClinicalTrials.gov

Time frame: 1-year. Reporting threshold: 3%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Gout Storytelling Video
Serious: 0/152 (0%)
Deaths: 4/152
Video About Management of Another Chronic Condition
Serious: 0/154 (0%)
Deaths: 5/154
Other adverse events (1 terms — click to expand)

ReactionSystemGout Storytelling VideoVideo About Management of …
Medication side effect on SATMED-Q side effectProduct Issues

Data from ClinicalTrials.gov NCT02741700 adverse events section.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Effectiveness of healthcare educational and behavioral interventions to improve gout outcomes: a systematic review and meta-analysis.
    Ramsubeik K, Ramrattan LA, Kaeley GS, Singh JA. · · 2018 · cited 17× · PMID 30515250 · DOI 10.1177/1759720x18807117
  2. SToRytelling to Improve Disease outcomes in Gout (STRIDE-GO): a multicenter, randomized controlled trial in African American veterans with gout.
    Singh JA, Joseph A, Baker J, Richman JS, et al · · 2021 · cited 4× · PMID 34749717 · DOI 10.1186/s12916-021-02135-w
  3. SToRytelliing to Improve Disease outcomes in Gout (STRIDE-GO) in African American veterans with gout: a trial study protocol.
    Singh JA. · · 2021 · cited 1× · PMID 34863255 · DOI 10.1186/s13063-021-05847-9

Verify or expand the search:

Other recruiting trials for Gout

Currently open trials in the same condition.

Other VA Office of Research and Development trials

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02741700.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing