Sickle cell disease (SCD) is a genetic disorder that affects 1 out of every 500 African Americans in the US. Characterized by chronic anemia, or low blood hemoglobin (Hgb) levels, patients with SCD also suffer from frequent and acute episodes of pain and fatigue. While current evidence indicates that chronically ill patients who engage in self-management improve their health outcomes, the multi-factorial symptoms of SCD are difficult for the patient to recognize and quantify. Interestingly, the onset of SCD complications are often associated with precipitous worsening of anemia. As such, Dr. Lam?s hematology bioengineering laboratory has recently developed an inexpensive, disposable, patient-operated, color-based, diagnostic that enables pediatric SCD patients to objectively self-monitor their anemia, the hallmark of their disease, and potentially allow them to engage in self-management and hopefully improve their overall clinical outcomes. In addition, the Lam laboratory has also developed an optional smartphone app that enables automated analysis and potential for data transmission. With initial proof-of-concept and clinical assessment studies successfully completed and published, we believe that due to the multifactorial biobehavioral nature of pain and fatigue in SCD, children and adolescents with SCD who self-monitor their anemia with our self-test will better recognize their own levels of pain and fatigue, and be better informed about when to seek appropriate medical care. This, in turn, could lead to reductions in emergency room visits and hospitalizations and improved clinical outcomes. For this grant, we will first conduct a 3 month home-based usability study in which 20 pediatric and adolescent SCD patients will test these devices on themselves for one month. We will then conduct semi-structured interviews to solicit feedback from these patients, which will inform any modifications we need to make to the biochemistry of the assay, the physical device, and the smartphone app. We will then a conduct a larger study in which 50 SCD pediatric and adolescent patients will be asked to perform anemia self-testing in conjunction with answering pain- and fatigue-related questions the day of their monthly visits and at the onset of any worsening of pain or fatigue symptoms. Specifically, we will answer these questions: 1) Does our anemia self- test provide an additional objective metric that assists pediatric patients in recognizing SCD symptoms that reflect worsening anemia? 2) Does anemia self-testing correlate with SCD pain/fatigue symptoms? 3) Does use of our anemia self-test better inform pediatric SCD patients about when to seek appropriate medical advice/care? At the end of this project, we will have an optimized and validated system that will enable us to conduct larger scale studies to determine whether home anemia self-testing can improve the clinical outcomes for SCD patients and decrease emergency room visits and urgent hospitalizations by detecting acute complications before they become life-threatening.

Public Health Relevance

Sickle cell disease (SCD) is a genetic blood disorder that is characterized by chronic anemia and frequent episodes of acute pain, which can be associated with concurrent worsening of the anemia. We have recently developed an inexpensive, disposable, patient-operated, color-based, diagnostic that could enable pediatric SCD patients to objectively self-monitor their anemia. The goal of this study is to evaluate the feasibility of our anemia self-test as a means to enable and improve disease self-management for pediatric and adolescent patients with SCD.

Agency
National Institute of Health (NIH)
Institute
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Type
Exploratory/Developmental Grants (R21)
Project #
5R21EB025646-02
Application #
9624759
Study Section
Biomedical Computing and Health Informatics Study Section (BCHI)
Program Officer
Lash, Tiffani Bailey
Project Start
2018-01-15
Project End
2019-11-30
Budget Start
2018-12-01
Budget End
2019-11-30
Support Year
2
Fiscal Year
2019
Total Cost
Indirect Cost
Name
Emory University
Department
Pediatrics
Type
Schools of Medicine
DUNS #
066469933
City
Atlanta
State
GA
Country
United States
Zip Code
30322
Mannino, Robert G; Myers, David R; Tyburski, Erika A et al. (2018) Smartphone app for non-invasive detection of anemia using only patient-sourced photos. Nat Commun 9:4924