RESUMEN
BACKGROUND: Cardiovascular disease (CVD) is the leading cause of death in the United States, affecting a significant proportion of adults. Digital health lifestyle change programs have emerged as a promising method of CVD prevention, offering benefits such as on-demand support, lower cost, and increased scalability. Prior research has shown the effectiveness of digital health interventions in reducing negative CVD outcomes. This pilot study focuses on the Lark Heart Health program, a fully digital artificial intelligence (AI)-powered smartphone app, providing synchronous CVD risk counseling, educational content, and personalized coaching. OBJECTIVE: This pilot study evaluated the feasibility and acceptability of a fully digital AI-powered lifestyle change program called Lark Heart Health. Primary analyses assessed (1) participant satisfaction, (2) engagement with the program, and (3) the submission of health screeners. Secondary analyses were conducted to evaluate weight loss outcomes, given that a major focus of the Heart Health program is weight management. METHODS: This study enrolled 509 participants in the 90-day real-world single-arm pilot study of the Heart Health app. Participants engaged with the app by participating in coaching conversations, logging meals, tracking weight, and completing educational lessons. The study outcomes included participant satisfaction, app engagement, the completion of screeners, and weight loss. RESULTS: On average, Heart Health study participants were aged 60.9 (SD 10.3; range 40-75) years, with average BMI indicating class I obesity. Of the 509 participants, 489 (96.1%) stayed enrolled until the end of the study (dropout rate: 3.9%). Study retention, based on providing a weight measurement during month 3, was 80% (407/509; 95% CI 76.2%-83.4%). Participant satisfaction scores indicated high satisfaction with the overall app experience, with an average score of ≥4 out of 5 for all satisfaction indicators. Participants also showed high engagement with the app, with 83.4% (408/489; 95% CI 80.1%-86.7%) of the sample engaging in ≥5 coaching conversations in month 3. The results indicated that participants were successfully able to submit health screeners within the app, with 90% (440/489; 95% CI 87%-92.5%) submitting all 3 screeners measured in the study. Finally, secondary analyses showed that participants lost weight during the program, with analyses showing an average weight nadir of 3.8% (SD 2.9%; 95% CI 3.5%-4.1%). CONCLUSIONS: The study results indicate that participants in this study were satisfied with their experience using the Heart Health app, highly engaged with the app features, and willing and able to complete health screening surveys in the app. These acceptability and feasibility results provide a key first step in the process of evidence generation for a new AI-powered digital program for heart health. Future work can expand these results to test outcomes with a commercial version of the Heart Health app in a diverse real-world sample.
RESUMEN
RESUMEN Objetivos. Evaluar la variación de los perfiles hematológicos antes, durante y después del tratamiento de pacientes infectados con malaria no complicada por Plasmodium vivax (Pv) y P. falciparum (Pf) en una población de la región Loreto. Materiales y métodos. El estudio se realizó entre 2010 y 2012, en Zungarococha (Iquitos). Los 425 participantes tuvieron tres visitas (visita 1-día 0-antes del tratamiento, visita 2-día 7-durante tratamiento, visita 3-día 28-después del tratamiento), hemograma completo, diagnóstico microscópico y molecular (PCR). Resultados. En la primera visita, se encontraron 93 (21,9%) positivos a Pv y 34 (8,0%) a Pf. Todos los positivos mostraron una reducción en los indicadores hematológicos de hematocrito, recuento de glóbulos blancos (RGB), neutrófilos abastonados y segmentados, eosinófilos y plaquetas (p<0.001) en comparación con el grupo negativo. Se encontró un porcentaje mayor de neutrófilos abastonados en Pf y de neutrófilos segmentados en Pv comparado al grupo negativo. Se observó variaciones en los perfiles hematológicos después del tratamiento para ambas especies, los neutrófilos abastonados disminuyeron, las plaquetas aumentaron, los eosinófilos se incrementaron al día 7 y decaen el día 28, el hematocrito y los neutrófilos segmentados disminuyeron al día 7 y se normalizaron el día 28. Las diferencias entre especies en el tiempo mostraron una disminución diaria de neutrófilos abastonados en infectados con Pv que en Pf. Conclusiones. El perfil hematológico en pacientes positivos a malaria no complicada varía en el tiempo durante y después del tratamiento. Estos son indicadores de la progresión de la enfermedad y ayudan en la vigilancia terapéutica de pacientes infectados con Plasmodium.
ABSTRACT Objectives. To evaluate the variation of hematological profiles of patients infected with uncomplicated Plasmodium vivax (Pv) and P. falciparum (Pf) malaria before, during and after treatment in a population of the Loreto region. Materials and methods. This study was conducted between 2010 and 2012, in Zungarococha (Iquitos). The 425 participants had three visits (visit 1-day 0-before treatment, visit 2-day 7-during treatment, visit 3-day 28-after treatment), complete blood count, microscopic and molecular diagnosis (PCR). Results. At the first visit, 93 (21.9%) participants were found positive for Pv and 34 (8.0%) for Pf. All positives showed a reduction in hematocrit, white blood cell count (WBC), ablated and segmented neutrophils, eosinophils and platelets (p<0.001) compared to the negative group. A higher percentage of ablated neutrophils was found in Pf and segmented neutrophils in Pv compared to the negative group. Variations in hematological profiles were observed after treatment for both species; ablated neutrophils decreased, platelets increased, eosinophils increased at day 7 and declined at day 28, hematocrit and segmented neutrophils decreased at day 7 and normalized at day 28. Interspecies differences over time showed a bigger daily decrease in ablated neutrophils in Pv-infected when compared to Pf. Conclusions. The hematological profile in uncomplicated malaria-positive patients varies over time during and after treatment. These are indicators of disease progression and help in the therapeutic surveillance of Plasmodium-infected patients.