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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.
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 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 the sustenance of the effect of the 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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gout storytelling video | Experimental | Participants view culturally relevant patient narrated storytelling in African-American Veterans' own voices about their experience with gout and its treatment and a patient narrated slide show of gout and its treatment. |
|
| Video about management of another chronic condition | Active Comparator | Participants view a patient narrated slide show of roughly the same duration as the experimental arm, summarizing the management of stress, a non-gout chronic condition. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gout Storytelling Video Intervention | Behavioral | The investigators developed a storytelling intervention for African-Americans with gout, to address barriers to optimal gout management and provide cues for better disease management, which were narrated by several Veterans with gout. One of the veterans also presented a PowerPoint on gout and its management. The intervention was shown to the participants on a touchscreen computer or the desktop screen at the baseline study visit. Subsequently, they were provided with DVD with similar intervention to watch at home. |
| Measure | Description | Time Frame |
|---|---|---|
| Medication Adherence | 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) | 3, 6, 9, and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Gout Flares | Participant-reported total number of gout flares in the last 1 month | 12 months |
| Patient Satisfaction | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jasvinder A Singh, MD MPH | Birmingham VA Medical Center, Birmingham, AL | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham VA Medical Center, Birmingham, AL | Birmingham | Alabama | 35233 | United States | ||
| St. Louis VA Medical Center John Cochran Division, St. Louis, MO |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34863255 | Derived | Singh JA. SToRytelliing to Improve Disease outcomes in Gout (STRIDE-GO) in African American veterans with gout: a trial study protocol. Trials. 2021 Dec 4;22(1):879. doi: 10.1186/s13063-021-05847-9. | |
| 34749717 | Derived | Singh JA, Joseph A, Baker J, Richman JS, Shaneyfelt T, Saag KG, Eisen S. SToRytelling to Improve Disease outcomes in Gout (STRIDE-GO): a multicenter, randomized controlled trial in African American veterans with gout. BMC Med. 2021 Nov 9;19(1):265. doi: 10.1186/s12916-021-02135-w. |
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Data are owned by the VA. only with the conditions and approvals from appropriate VA authorities, we are willing to share de-identified data with requesters.
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| ID | Title | Description |
|---|---|---|
| FG000 | Gout Storytelling Video | Patients view a culturally relevant patient storytelling in African-American Veterans' own voices about gout and its treatment. 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. |
| FG001 | 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. 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Gout Storytelling Video | Patients view a culturally relevant patient storytelling in African-American Veterans' own voices about gout and its treatment. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Medication Adherence | 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) | Posted | Mean | 95% Confidence Interval | percentage of days ULT was taken | 3, 6, 9, and 12 months |
|
1-year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Gout Storytelling Video | Patients view a culturally relevant patient storytelling in African-American Veterans' own voices about gout and its treatment. 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Medication side effect on SATMED-Q side effect | Product Issues | Non-systematic Assessment | Medication side effect on SATMED-Q side effect question- side effects not specified |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jasvinder Singh | VA ORD: Birmingham VA Medical Center | 205-934-3235 | jasvinder.md@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 22, 2018 | Dec 6, 2021 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 16, 2018 | Dec 6, 2021 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D006073 | Gout |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D000070657 | Crystal Arthropathies |
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|
| 12 months |
| Target Serum Urate | Serum urate with absolute value in mg/dl, as indirect measures of better ULT adherence and important gout outcomes | 12 months |
| St Louis |
| Missouri |
| 63106 |
| United States |
| Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA | Philadelphia | Pennsylvania | 19104 | United States |
| Physician Decision |
|
| Moved out of State |
|
| Death |
|
| BG001 | 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. 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | 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. 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. |
|
|
| Secondary | Gout Flares | Participant-reported total number of gout flares in the last 1 month | Posted | Mean | 95% Confidence Interval | Self-reported gout flares in 1 month | 12 months |
|
|
|
| Secondary | Patient Satisfaction | 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. | Posted | Mean | 95% Confidence Interval | units on a scale | 12 months |
|
|
|
| Secondary | Target Serum Urate | Serum urate with absolute value in mg/dl, as indirect measures of better ULT adherence and important gout outcomes | Posted | Mean | 95% Confidence Interval | mg/dL | 12 months |
|
|
|
| 4 |
| 152 |
| 0 |
| 152 |
| 9 |
| 152 |
| EG001 | 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. 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. | 5 | 154 | 0 | 154 | 5 | 154 |
|
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| D012216 |
| Rheumatic Diseases |
| D011686 | Purine-Pyrimidine Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |