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

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ClinicalTrials.gov Identifier: NCT02741700
Recruitment Status : Recruiting
First Posted : April 18, 2016
Last Update Posted : March 20, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Tracking Information
First Submitted Date  ICMJE March 21, 2016
First Posted Date  ICMJE April 18, 2016
Last Update Posted Date March 20, 2019
Actual Study Start Date  ICMJE May 31, 2017
Estimated Primary Completion Date September 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 16, 2018)
Medication Adherence [ Time Frame: 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 durability of effect),
Original Primary Outcome Measures  ICMJE
 (submitted: April 14, 2016)
Medication Adherence [ Time Frame: 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 durability of effect),
Change History Complete list of historical versions of study NCT02741700 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 16, 2018)
  • Gout flare rate [ Time Frame: 12 months ]
    Gout flare rate assessed by the 2012 validated Gout Flare Definition and by patient-reported gout flare
  • Patient Satisfaction [ Time Frame: 12 months ]
    Patient satisfaction with medication on patient questionnaire
  • Target Serum Urate [ Time Frame: 12 months ]
    Target serum urate (sUA): proportion with <6 mg/dl achievement and with absolute value in mg/dl, as indirect measures of better ULT adherence and important gout outcomes
Original Secondary Outcome Measures  ICMJE
 (submitted: April 14, 2016)
  • Gout flare rate [ Time Frame: 12 months ]
    Gout flare rate assessed by the 2012 Gout Flare Definition
  • Patient Satisfaction [ Time Frame: 12 months ]
    Patient satisfaction on patient questionnaire
  • Target Serum Urate [ Time Frame: 12 months ]
    Target serum urate (sUA) <6 mg/dl achievement, as indirect measures of better ULT adherence and important gout outcomes
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE SToRytelling to Improve DiseasE Outcomes in GOut: The STRIDE-GO 2 Study
Official Title  ICMJE STorytelling to Improve DiseasE Outcomes in GoUT: The STRIDE-GO Study
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.
Detailed Description

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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Gout
  • Low Medication Adherence
  • Health Related Quality of Life
Intervention  ICMJE Behavioral: Improvement of Medication Adherence
The investigators have developed a storytelling intervention for African-Americans with gout, to address barriers to optimal gout management and provide cues for better disease management. The objective of this study is to assess the efficacy of a novel storytelling intervention in Veteran's own voices to improve medication adherence and patient outcomes in African-American Veterans with gout.
Study Arms  ICMJE
  • Experimental: Gout storytelling video
    Patients view a culturally relevant patient storytelling in African-American Veterans' own voices about gout and its treatment.
    Intervention: Behavioral: Improvement of Medication Adherence
  • Active Comparator: Video about management of another chronic condition
    Patient narrated slide show of roughly the same duration as the experimental arm, summarizing management of a non-gout condition.
    Intervention: Behavioral: Improvement of Medication Adherence
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 14, 2016)
300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 28, 2021
Estimated Primary Completion Date September 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jasvinder A Singh, MD MPH (205) 933-8101 ext 2280 jasvinder.singh@va.gov
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02741700
Other Study ID Numbers  ICMJE IIR 13-314
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party VA Office of Research and Development
Study Sponsor  ICMJE VA Office of Research and Development
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jasvinder A Singh, MD MPH Birmingham VA Medical Center, Birmingham, AL
PRS Account VA Office of Research and Development
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP