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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 : August 27, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

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.

Condition or disease Intervention/treatment Phase
Gout Low Medication Adherence Health Related Quality of Life Behavioral: Improvement of Medication Adherence Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: STorytelling to Improve DiseasE Outcomes in GoUT: The STRIDE-GO Study
Actual Study Start Date : May 31, 2017
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : February 28, 2021

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Gout
MedlinePlus related topics: Gout

Arm Intervention/treatment
Experimental: Gout storytelling video
Patients view a culturally relevant patient storytelling in African-American Veterans' own voices about gout and its treatment.
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.

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.
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.




Primary Outcome Measures :
  1. 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),


Secondary Outcome Measures :
  1. Gout flare rate [ Time Frame: 12 months ]
    Gout flare rate assessed by the 2012 validated Gout Flare Definition and by patient-reported gout flare

  2. Patient Satisfaction [ Time Frame: 12 months ]
    Patient satisfaction with medication on patient questionnaire

  3. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02741700


Contacts
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Contact: Jasvinder A Singh, MD MPH (205) 933-8101 ext 2280 jasvinder.singh@va.gov

Locations
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United States, Alabama
Birmingham VA Medical Center, Birmingham, AL Recruiting
Birmingham, Alabama, United States, 35233
Contact: Jasvinder A Singh, MD MPH    205-933-8101 ext 2280    jasvinder.singh@va.gov   
Contact: Holly M Deal, MBA    (205) 933-8101 ext 5301    holly.deal@va.gov   
Principal Investigator: Jasvinder A Singh, MD MPH         
United States, Missouri
St. Louis VA Medical Center John Cochran Division, St. Louis, MO Recruiting
Saint Louis, Missouri, United States, 63106
Contact: Amy M Joseph       Amy.Joseph@va.gov   
Contact: Ziyad Al-Aly, MD    (314) 289-6485    Ziyad.Al-Aly@va.gov   
Sub-Investigator: Amy M. Joseph         
United States, Pennsylvania
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Joan M Von Feldt, MD MSEd    215-823-5800    Joan.VonFeldt@va.gov   
Contact: Said A Ibrahim, MD MPH MBA    (215) 823-5847    said.ibrahim2@va.gov   
Sub-Investigator: Joshua F. Baker, MD MSCE         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Jasvinder A Singh, MD MPH Birmingham VA Medical Center, Birmingham, AL

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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02741700     History of Changes
Other Study ID Numbers: IIR 13-314
First Posted: April 18, 2016    Key Record Dates
Last Update Posted: August 27, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by VA Office of Research and Development:
Adherence
Disparities
Patient Outcomes
Additional relevant MeSH terms:
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Gout
Arthritis
Joint Diseases
Musculoskeletal Diseases
Crystal Arthropathies
Rheumatic Diseases
Purine-Pyrimidine Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases