Ignite Creation Date:
2024-05-06 @ 8:27 AM
Last Modification Date:
2024-10-26 @ 12:00 PM
Study NCT ID:
NCT02741700
Status:
COMPLETED
Last Update Posted:
2022-03-17
First Post:
2016-03-21
Brief Title:
SToRytelling to Improve DiseasE Outcomes in GOut The STRIDE-GO2 Study
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
STorytelling to Improve DiseasE Outcomes in GoUT The STRIDE-GO Study
Status:
COMPLETED
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STRIDE-GO2
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 dont 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 patients 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 patients 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 ie 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 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 mgdl 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 VAs 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
Alignment with VA mission and priorities This study serves the VAs 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None