Dataset Information

SToRytelling to Improve Disease outcomes in Gout (STRIDE-GO): a multicenter, randomized controlled trial in African American veterans with gout

ABSTRACT:

Background

Urate-lowering therapy (ULT) adherence is low in gout, and few, if any, effective, low-cost, interventions are available. Our objective was to assess if a culturally appropriate gout-storytelling intervention is superior to an attention control for improving gout outcomes in African-Americans (AAs).

Methods

In a 1-year, multicenter, randomized controlled trial, AA veterans with gout were randomized to gout-storytelling intervention vs. a stress reduction video (attention control group; 1:1 ratio). The primary outcome was ULT adherence measured with MEMSCap™, an electronic monitoring system that objectively measured ULT medication adherence.

Results

The 306 male AA veterans with gout who met the eligibility criteria were randomized to the gout-storytelling intervention (n = 152) or stress reduction video (n = 154); 261/306 (85%) completed the 1-year study. The mean age was 64 years, body mass index was 33 kg/m2, and gout disease duration was 3 years. ULT adherence was similar in the intervention vs. control groups: 3 months, 73% versus 70%; 6 months, 69% versus 69%; 9 months, 66% versus 67%; and 12 months, 61% versus 64% (p > 0.05 each). Secondary outcomes (gout flares, serum urate and gout-specific health-related quality of life [HRQOL]) in the intervention versus control groups were similar at all time points except intervention group outcomes were better for the following: (1) number of gout flares at 9 months were fewer, 0.7 versus 1.3 in the previous month (p = 0.03); (2) lower/better scores on two gout specific HRQOL subscales: gout medication side effects at 3 months, 32.8 vs. 39.6 (p = 0.02); and unmet gout treatment need at 3 months, 30.9 vs. 38.2 (p = 0.003), and 6 months, 29.5 vs. 34.5 (p = 0.03), respectively.

Conclusions

A culturally appropriate gout-storytelling intervention was not superior to attention control for improving gout outcomes in AAs with gout.

Trial registration

Registered at ClinicalTrials.gov NCT02741700

Supplementary Information

The online version contains supplementary material available at 10.1186/s12916-021-02135-w.

SUBMITTER: Singh J

PROVIDER: S-EPMC8576883 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description:ObjectiveMedication adherence in gout is suboptimal, and the lack of effective interventions to address it presents a huge challenge. Medication adherence and gout outcomes are worse in racial/ethnic minorities. The objective of this paper was to provide the details of the study protocol for randomized, controlled trial (RCT) in African Americans (AAs) with gout that will test the effectiveness of a culturally appropriate gout storytelling intervention.MethodsThe SToRytelliing to Improve Disease outcomes in Gout (STRIDE-GO) study will be a 12-month, multicenter, open-label RCT that will assess the effect of a culturally appropriate gout storytelling in at least 300 AA veterans with gout. Participants will be randomized to gout-storytelling intervention vs. a stress reduction video in a 1:1 ratio. The primary outcome is urate-lowering therapy (ULT) adherence measured with MEMSCap™, an electronic monitoring system (efficacy, 6 months; sustenance of efficacy, 12 months). Secondary outcomes include gout flares, serum urate (SU), gout-specific health-related quality of life [HRQOL], self-reported ULT adherence, patient satisfaction with treatment, and patient understanding of the intervention. AA veterans with gout who met the 1977 Preliminary American College of Rheumatology (ACR) classification criteria for gout, currently prescribed an oral ULT medication (allopurinol or febuxostat) for at least 6 months, and not using a pillbox to redistribute their medications, will be invited to an in-person study visit. After the study coordinators obtain informed consent, and ensure that participants meet the inclusion criteria, the eligible participants will be provided with their current ULT in a MEMSCap™ bottle for the 1-month run-in period and asked to return to the clinic in 1 month. ULT adherence with MEMSCap™ will be recorded at a 1-month return visit. Interested participants will complete the baseline assessments, randomized using the computerized system to either gout-storytelling intervention or a stress reduction intervention video arm and watch the respective video in-clinic. Patients will be interviewed on the phone at 2 and 4 months regarding the viewing of the videos at home at each time. Participants will be assessed in-clinic at 3, 6, 9, and 12 months; MEMSCap™ data and patient surveys will be captured at each visit. For any missed visit, assessments will be completed on the phone and MEMSCap™ data captured at the next in-clinic visit.DiscussionThe study will assess the efficacy of a behavioral intervention to improve ULT adherence in minority populations with gout.Trial registrationClinicalTrials.gov NCT02741700. Registered on 14 September 2018.

Project description:BACKGROUND:In the general population, compared wtih their White peers, African Americans suffer premature all-cause and cardiovascular (CV) deaths, attributed in part to reduced access to care and lower socioeconomic status. Prior reports indicated younger (aged 35 to 44 years) African Americans had a signficantly greater age-adjusted risk of death. Recent studies suggest that in a more egalitarian health care structure than typical United States (US) health care structures, African Americans may have similar or even better CV outcomes, but the impact of age is less well-known. METHODS:We examined age stratified all-cause mortality, and incident coronary heart disease (CHD) and ischemic stroke in 3,072,966 patients (547,441 African American and 2,525,525 White) with an estimated glomerular filtration rate (eGFR)>60 mL/min/1.73m(2) receiving care from the US Veterans Health Administration. Outcomes were examined in Cox models adjusted for demographics, comorbidities, kidney function, blood pressure, socioeconomics and indicators of the quality of health care delivery. RESULTS:African Americans had an overall 30% lower all-cause mortality (P<.001) and 29% lower incidence of CHD (P<.001) and higher incidence of ischemic stroke (aHR, 95%CI: 1.16, 1.13-1.18, P<.001). The lower rates of mortality and CHD were strongest in younger African Americans and attenuated across patients aged ?70 years. Stroke rates did not differ by race in persons aged <70 years. CONCLUSIONS:Among patients with normal eGFR and receiving care in the Veterans Health Administration, younger African Americans had lower all-cause mortality and incidence of CHD and similar rates of stroke, independent of demographic, comorbidity and socioeconomic differences. The lower all-cause mortality persisted but attenuated with increasing age and the lower incidence of CHD ended at aged ?80 years. The higher incidence of ischemic stroke in African Americans was driven by increasing risk in patients aged ?70 years suggesting that the improved cardiovascular outcomes were most dramatic for younger African Americans.

Project description:BACKGROUND:Compared with white persons, African Americans have a greater incidence of diabetes, decreased control, and higher rates of microvascular complications. A peer mentorship model could be a scalable approach to improving control in this population and reducing disparities in diabetic outcomes. OBJECTIVE:To determine whether peer mentors or financial incentives are superior to usual care in helping African American veterans decrease their hemoglobin A(1c) (HbA(1c)) levels. DESIGN:A 6-month randomized, controlled trial. (ClinicalTrials.gov registration number: NCT01125956) SETTING:Philadelphia Veterans Affairs Medical Center. PATIENTS:African American veterans aged 50 to 70 years with persistently poor diabetes control. INTERVENTION:118 patients were randomly assigned to 1 of 3 groups: usual care, a peer mentoring group, and a financial incentives group. Usual care patients were notified of their starting HbA(1c) level and recommended goals for HbA(1c). Those in the peer mentoring group were assigned a mentor who formerly had poor glycemic control but now had good control (HbA(1c) level ?7.5%). The mentor was asked to talk with the patient at least once per week. Peer mentors were matched by race, sex, and age. Patients in the financial incentive group could earn $100 by decreasing their HbA(1c) level by 1% and $200 by decreasing it by 2% or to an HbA(1c) level of 6.5%. MEASUREMENTS:Change in HbA(1c) level at 6 months. RESULTS:Mentors and mentees talked the most in the first month (mean calls, 4; range, 0 to 30), but calls decreased to a mean of 2 calls (range, 0 to 10) by the sixth month. Levels of HbA(1c) decreased from 9.9% to 9.8% in the control group, from 9.8% to 8.7% in the peer mentor group, and from 9.5% to 9.1% in the financial incentive group. Mean change in HbA(1c) level from baseline to 6 months relative to control was -1.07% (95% CI, -1.84% to -0.31%) in the peer mentor group and -0.45% (CI, -1.23% to 0.32%) in the financial incentive group. LIMITATION:The study included only veterans and lasted only 6 months. CONCLUSION:Peer mentorship improved glucose control in a cohort of African American veterans with diabetes. PRIMARY FUNDING SOURCE:National Institute on Aging Roybal Center.

Project description:BACKGROUND:Research suggests that at least 10% of veterans returning from Iraq and Afghanistan meet criteria for posttraumatic stress disorder (PTSD) related to their military experiences. National dissemination initiatives have increased veterans' access to best-practice interventions. However, treatment-seeking remains low among veterans with PTSD, often due to perceived stigma and other associated barriers. The National Center for PTSD recently developed and launched AboutFace, a digital storytelling (DST) resource designed to help veterans recognize PTSD and motivate them to seek evidence-based treatment. The Ralph H. Johnson Veterans Affairs Medical Center (VAMC) and the National Center for PTSD have partnered to conduct pilot work to evaluate veterans' reactions to AboutFace to set the stage for a large-scale study to examine whether AboutFace effectively reduces stigma and improves attitudes toward treatment-seeking among veterans. If effective, this DST approach may serve as a valuable national model for a variety of treatment-seeking populations. METHODS:During the first phase of the pilot, in-person usability assessments of AboutFace will be conducted via semi-structured interviews with 20 veterans. Audio recordings of interviews will undergo transcription and coding. A report of the results of qualitative analyses of these interviews will be provided to the National Center for PTSD and will inform revisions to the site. In the second phase of the pilot, 60 veterans referred to a specialized PTSD clinic will be recruited to demonstrate and refine the methodology that we propose to use in a larger randomized controlled trial evaluation of AboutFace. Veterans will be randomly assigned to receive AboutFace plus standard education vs. standard education alone. Baseline and 2-week telephone assessments will be conducted with participating veterans to measure stigma, attitudes toward seeking mental health services, and treatment access/engagement. DISCUSSION:The feedback we receive in this pilot will be used to strengthen the quality of the DST website in preparation for a large-scale evaluation. Future work will involve evaluation of reach and impact of the site relative to stigma, attitudes toward seeking mental health service, and utilization of care. If AboutFace is found to increase access to care, this finding would have broad and significant implications for overcoming barriers to care for veterans and other populations with stigmatized conditions. TRIAL REGISTRATION:Clinicaltrials.gov, NCT02486692.

Project description:ImportancePeripartum cardiomyopathy (PPCM) disproportionately affects women of African ancestry, but well-powered studies to explore differences in severity of disease and clinical outcomes are lacking.ObjectiveTo compare the clinical characteristics, presentation, and outcomes of PPCM between African American and non-African American women.Design, setting, and participantsThis retrospective cohort study using data from January 1, 1986, through December 31, 2016, performed at the University of Pennsylvania Health System, a tertiary referral center serving a population with a high proportion of African American individuals, included 220 women with PPCM.Main outcomes and measuresDemographic and clinical characteristics and echocardiographic findings at presentation, as well as clinical outcomes including cardiac recovery, time to recovery, cardiac transplant, persistent dysfunction, and death, were compared between African American and non-African American women with PPCM.ResultsA total of 220 women were studied (mean [SD] age at diagnosis, 29.5 [6.6] years). African American women were diagnosed with PPCM at a younger age (27.6 vs 31.7 years, P < .001), were diagnosed with PPCM later in the postpartum period, and were more likely to present with a left ventricular ejection fraction less than 30% compared with non-African American women (48 [56.5%] vs 30 [39.5%], P = .03). African American women were also more likely to worsen after initial diagnosis (30 [35.3%] vs 14 [18.4%], P = .02), were twice as likely to fail to recover (52 [43.0%] vs 24 [24.2%], P = .004), and, when they did recover, recovery took at least twice as long (median, 265 vs 125.5 days; P = .02) despite apparent adequate treatment.Conclusions and relevanceIn a large cohort of women with well-phenotyped PPCM, this study demonstrates a different profile of disease in African American vs non-African American women. Further work is needed to understand to what extent these differences stem from genetic or socioeconomic differences and how treatment of African American patients might be tailored to improve health outcomes.