Digital App for Sickle Cell Disease Screening
(SIMCS SCD Trial)
Trial Summary
What is the purpose of this trial?
Although over 75% of children with sickle cell disease (SCD) are born in sub-Sahara where the disease highly contributes to under-5 mortality and causes life-long debilitation, evidence-based strategies to control SCD are not widely implemented in this region. Early detection of SCD by universal infant screening is a pillar of SCD control. Despite the affordability and move to adopt point-of-care (POC) SCD screening assays in sub-Sahara Africa, the absence of screening information management and communication systems (SIMCS) impedes standardized, systematic, coordinated, nationwide SCD screening programs. The long-term goal of the proposed research is to develop a SCD SIMCS that will enable universal SCD screening in the sub-Sahara African setting. The objective is to test and optimize a custom SCD SIMCS app and digital network to facilitate SCD screening and then evaluate its impact on access to SCD screening and care and on clinical outcomes of children with SCD in Uganda. The central hypothesis is that the SCD SIMCS will facilitate accurate and coordinated POC SCD screening that is accessible at health centers in urban and rural Uganda. The rationale is to build a custom SCD SIMCS on existing nationwide digital and health infrastructure in Uganda to standardize use of affordable POC assays at health centers nationwide. The central hypothesis will be tested by pursuing two specific aims: 1) Develop and evaluate a four-module ≥3G cell phone app for a novel SCD SIMCS (R21 Phase); 2) Evaluate the impact of the SCD SIMCS on access to screening and care and outcomes of children with SCD (R33 Phase). The investigators will pursue these aims using an innovative combination of software design and re-organization of SCD screening workflows. These include assembly of off-the-shelf software that is compatible with iOS and Android operating systems to reliably, accurately, and handily capture, interpret, transmit, and retrieve/playback information for patient's IDs, test results, salient clinical events, and education. The novel screening workflows are expected to dramatically reduce the cost and increase access to SCD screening and care. The proposed research is significant, because it will determine how to use POC SCD screening assays on a large nationwide scale. It will also enable coordination of evidence-based care and continuity of care between primary and specialist providers and longitudinally over the patient's lifetime - a critical aspect in controlling this life-long disease. The SCD SIMCS will also facilitate real time data management for research and policy for SCD control. The expected immediate outcome of this research is a SCD SIMCS that optimally functions on the digital and health infrastructure in Uganda and demonstration of its impact on access to SCD screening and care and on clinical outcomes of children with SCD. The expected long-term outcome is that the SCD SIMCS will be adopted, integrated, and scaled-up in the health systems of Uganda and other sub-Sahara Africa countries, particularly those where the POC assays have already been adopted as the national standard of SCD screening. If effective, the SCD SIMCS will have an important positive impact because it will reduce the cost of SCD screening, take screening services and evidence-based care closer to rural communities where the majority of children in sub-Sahara Africa live, and, ultimately, save millions of children from preventable and disability death.
Will I have to stop taking my current medications?
The trial information does not specify whether participants need to stop taking their current medications.
What data supports the effectiveness of the digital app treatment for sickle cell disease screening?
Research shows that mobile apps can help people with sickle cell disease manage their health better. For example, one study found that using an app improved self-management and communication with healthcare providers, while another study showed that frequent app use was linked to better mood and less pain.12345
Is the digital app for sickle cell disease screening safe for humans?
How does the digital app for sickle cell disease screening differ from other treatments?
The digital app for sickle cell disease screening is unique because it leverages mobile health technology to improve self-management and communication with healthcare providers, unlike traditional treatments that focus solely on medication. This app allows patients to track symptoms, manage pain, and engage in health-promoting behaviors, providing a comprehensive approach to managing the condition.138910
Eligibility Criteria
This trial is for infants in sub-Saharan Africa, specifically Uganda, to improve early detection and management of Sickle Cell Disease (SCD). It aims to integrate a digital app and information system into existing healthcare infrastructure.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Development and Evaluation
Development and evaluation of a four-module ≥3G cell phone app for a novel SCD screening information management and communication system (SIMCS)
Cluster Randomized Trial
Conduct a Cluster Randomized Trial (CRT) involving health centers in one urban district (Kampala) and three rural districts
Follow-up
Participants are monitored for safety and effectiveness after the implementation of the SCD SIMCS
Treatment Details
Interventions
- Digital app and information system
Find a Clinic Near You
Who Is Running the Clinical Trial?
Makerere University
Lead Sponsor
Ministry of Health, Uganda
Collaborator
Baylor College of Medicine
Collaborator