SToRytelling to Improve DiseasE Outcomes in GOut: The STRIDE-GO 2 Study
| Status: | Recruiting |
|---|---|
| Conditions: | Gout |
| Therapuetic Areas: | Rheumatology |
| Healthy: | No |
| Age Range: | 19 - Any |
| Updated: | 3/22/2019 |
| Start Date: | May 31, 2017 |
| End Date: | February 28, 2021 |
| Contact: | Jasvinder A Singh, MD MPH |
| Email: | jasvinder.singh@va.gov |
| Phone: | (205) 933-8101 |
STorytelling to Improve DiseasE Outcomes in GoUT: The STRIDE-GO Study
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.
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.
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.
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.
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
We found this trial at
3
sites
Birmingham, Alabama 35233
Principal Investigator: Jasvinder A Singh, MD MPH
Phone: 205-933-8101
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3900 Woodland Avenue
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
Phone: 215-823-5800
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915 North Grand Boulevard
Saint Louis, Missouri 63106
Saint Louis, Missouri 63106
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