Browsing by Author "King, Allison A"
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Item Open Access A multilevel mHealth intervention boosts adherence to hydroxyurea in individuals with sickle cell disease.(Blood advances, 2023-09) Hankins, Jane S; Brambilla, Donald; Potter, Michael B; Kutlar, Abdullah; Gibson, Robert; King, Allison A; Baumann, Ana A; Melvin, Cathy; Gordeuk, Victor R; Hsu, Lewis L; Nwosu, Chinonyelum; Porter, Jerlym S; Alberts, Nicole M; Badawy, Sherif M; Simon, Jena; Glassberg, Jeffrey A; Lottenberg, Richard; DiMartino, Lisa; Jacobs, Sara; Fernandez, Maria E; Bosworth, Hayden B; Klesges, Lisa M; Shah, NirmishHydroxyurea reduces sickle cell disease (SCD) complications, but medication adherence is low. We tested two mobile health (mHealth) interventions targeting determinants of low adherence among patients (InCharge Health) and low prescribing among providers (HU Toolbox) in a multi-center non-randomized trial of individuals with SCD ages 15-45. We compared the percentage of days covered (PDC), labs, healthcare utilization, and self-reported pain over 24 weeks of intervention and 12 weeks post-study with a 24-week pre-intervention interval. We enrolled 293 patients (51% male; median age 27.5 years, 86.8% HbSS/HbSβ0-thalassemia). The mean change in PDC among 235 evaluable subjects increased (39.7% to 56.0%; p<0.001) and sustained (39.7% to 51.4%, p<0.001). Mean HbF increased (10.95% to 12.78%; p=0.03). Self-reported pain frequency fell (3.54 to 3.35 events/year; p=0.041). InCharge Health was used >or=1 day by 199 of 235 participants (84.7% implementation; median usage: 17% study days; IQR: 4.8-45.8%). For individuals with >or=1 baseline admission for pain, admissions per 24 weeks declined from baseline through 24 weeks (1.97 to 1.48 events/patient, p=0.0045) and weeks 25-36 (1.25 events/patient, p=0.0015). PDC increased with app use(p<0.001), with the greatest effect in those with private insurance (p=0.0078), in older subjects (p=0.033), and those with lower pain interference (p=0.0012). Of the 89 providers (49 hematologists, 36 advanced care providers, four unreported), only 11.2% used HU Toolbox >or=1/month on average. This use did not affect change in PDC. Tailoring mHealth solutions to address barriers to hydroxyurea adherence has the potential to improve adherence and provide clinical benefits. A definitive randomized study is warranted.Item Open Access End points for sickle cell disease clinical trials: patient-reported outcomes, pain, and the brain.(Blood advances, 2019-12) Farrell, Ann T; Panepinto, Julie; Carroll, C Patrick; Darbari, Deepika S; Desai, Ankit A; King, Allison A; Adams, Robert J; Barber, Tabitha D; Brandow, Amanda M; DeBaun, Michael R; Donahue, Manus J; Gupta, Kalpna; Hankins, Jane S; Kameka, Michelle; Kirkham, Fenella J; Luksenburg, Harvey; Miller, Shirley; Oneal, Patricia Ann; Rees, David C; Setse, Rosanna; Sheehan, Vivien A; Strouse, John; Stucky, Cheryl L; Werner, Ellen M; Wood, John C; Zempsky, William TTo address the global burden of sickle cell disease (SCD) and the need for novel therapies, the American Society of Hematology partnered with the US Food and Drug Administration to engage the work of 7 panels of clinicians, investigators, and patients to develop consensus recommendations for clinical trial end points. The panels conducted their work through literature reviews, assessment of available evidence, and expert judgment focusing on end points related to: patient-reported outcomes (PROs), pain (non-PROs), the brain, end-organ considerations, biomarkers, measurement of cure, and low-resource settings. This article presents the findings and recommendations of the PROs, pain, and brain panels, as well as relevant findings and recommendations from the biomarkers panel. The panels identify end points, where there were supporting data, to use in clinical trials of SCD. In addition, the panels discuss where further research is needed to support the development and validation of additional clinical trial end points.