Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06563440
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-19
Brief Title:
Development and Evaluation of an Information Management System and Communication System for Population-wide Point-of-care Infant Sickle Cell Disease Screening
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Development and Evaluation of an Information Management System and Communication System for Population-wide Point-of-care Infant Sickle Cell Disease Screening
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SIMCS SCD
Brief Summary:
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 retrieveplayback information for patients 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 patients 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
Detailed Description:
This trial builds on our multidisciplinary experience in pediatric sickle cell disease SCD care mHealth platforms and community-based research in Uganda to develop validate and trial a novel SCD screening information management and communication system SCD SIMCS that enables community-wide point-of-care POC SCD screening and care coordination The SCD SIMCS network will be built on existing population-wide digital infrastructure and a Tier2 data center at the Uganda Ministry of Health MOH hub The network will consist of 3 components 1 2G cell phone patients for short message service SMS 2 3G cell phone providers for a custom Application App that facilitates SCD testing patient education and care coordination 3 Tier2 data center MOH hub to receive curate and transmit data and information in the SCD SIMCS network The network will involve families primary care providers PCP pediatric hematology specialists and a national MOH hub for SCD screening The purpose is to improve outcomes of children with SCD through early detection and linkage into care
SCD is a group of inherited chronic red blood cell RBC disorders characterized by chronic hemolytic anemia pain crises and end-organ damage SCD affects about 15 million individuals in SSA and about 340000 children are born with the disease annually Only 10 of these children reach adolescence in SSA compared to almost 90 of patients that reach adulthood in high-income countries3 Although SCD contributes about 16 of under-5 mortality in SSA it is under-recognized because most children die of the disease without a diagnosis
Early detection through screening is the foremost strategy in reducing SCD morbidity and mortality because it is a pre-requisite for prevention of complications using interventions such as hydroxyurea vaccination and health education24 Whereas several assays for SCD screening exist attempts to introduce them in SSA at a large scale have been futile because of the unaffordable logistics and complex workflows involved in traditional designs of infant screening programs Transportation of samples and maintenance of sample-patient ID transmission of test results to families and providers pre- and post-screening counseling referral for treatment for those diagnosed with SCD and program evaluation are all critical steps in screening and are dependent on affordability reliability and integrity of information transfer between the stakeholders at each step The investigators hypothesize that the SCD SIMCS will bridge these gaps in the screening process in Uganda and sustainably improve outcomes of children with SCD The investigators propose the following Specific Aims to develop validate and trial a sustainable and error-proof mHealth system that will subsequently be adoptable and sustainable to facilitate population-wide SCD screening in Uganda
Aim 1 To develop and evaluate a four-module 3G cell phone app for a novel SCD screening information management and communication system SIMCS R21 Phase The App will capture and interpret POC assays capture and maintain a high-fidelity patient ID system serve as a SCD e-passport interface and facilitate SCD pre- and post- test counseling The investigators will iteratively test the feasibility accuracy reproducibility efficacy and robustness of the custom App and SCD SIMCS in our Mulago National Referral Hospital MNRHMakerere University College of Health Sciences MakCHS Sickle Cell Program and affiliated primary health centers in Kampala The goal is to enable a simple error-free reliable and standardized SCD screening using a low-cost POC assay that can be performed across wide ranging health center levels and health worker expertise and facilitate efficient information sharing and coordination between stakeholders
Aim 2 To evaluate the impact of the SCD SIMCS on access to screening and care and outcomes of children with SCD R33 Phase Hypotheses The SCD SIMCS will enable universal SCD screening of infants in participating communities facilitate coordination of their clinical care and result in reduction of morbidity and mortality due to SCD in participating communities The investigators will perform a clustered randomized trial CRT of the SCD SIMCS among health centers in one urban and three rural districts of Uganda The goal is to generate community level evidence on the impact of the SCD SIMCS to inform its adoption and expansion to a national scale in Uganda and adaptation to other LMIC countries
In Phase 1 the investigators will finalize creation of short videos for patient education integrate the modules of the SCD SIMCS 3G cell phone App and test its integration with the Ministry of Health MOH Tier3 data center The investigators will also optimize the analytics and informatics algorithms for data transmitted to the MOH data center Reiterations of improvements and testing to optimize the design and functionalities of the App and SCD SIMCS will be made based on user feedback Phase 1 will be conducted at Mulago National Referral Hospital and later piloted in a sample of health centers in the city of Kampala In Phase 2 the investigators will conduct a Cluster Randomized Trial CRT involving health centers in one urban district Kampala and three rural districts that have established community research infrastructure the Iganga-Mayuge Health Demographic Survey Site IMHDSS and Rakai Health Research Program RHRP
The investigators expect the proposed SCD SIMCS to reduce SCD mortality and morbidity by expanding access to screening facilitating continuity and coordination of care and providing real time data for national SCD policy and planning and research Our team involves stakeholders with the mandate and resources to successfully conduct the proposed research and most critically to integrate and sustain the SCD SIMCS in the health system
SCD is a group of inherited chronic red blood cell RBC disorders characterized by chronic hemolytic anemia pain crises and end-organ damage SCD affects about 15 million individuals in SSA and about 340000 children are born with the disease annually Only 10 of these children reach adolescence in SSA compared to almost 90 of patients that reach adulthood in high-income countries3 Although SCD contributes about 16 of under-5 mortality in SSA it is under-recognized because most children die of the disease without a diagnosis
Early detection through screening is the foremost strategy in reducing SCD morbidity and mortality because it is a pre-requisite for prevention of complications using interventions such as hydroxyurea vaccination and health education24 Whereas several assays for SCD screening exist attempts to introduce them in SSA at a large scale have been futile because of the unaffordable logistics and complex workflows involved in traditional designs of infant screening programs Transportation of samples and maintenance of sample-patient ID transmission of test results to families and providers pre- and post-screening counseling referral for treatment for those diagnosed with SCD and program evaluation are all critical steps in screening and are dependent on affordability reliability and integrity of information transfer between the stakeholders at each step The investigators hypothesize that the SCD SIMCS will bridge these gaps in the screening process in Uganda and sustainably improve outcomes of children with SCD The investigators propose the following Specific Aims to develop validate and trial a sustainable and error-proof mHealth system that will subsequently be adoptable and sustainable to facilitate population-wide SCD screening in Uganda
Aim 1 To develop and evaluate a four-module 3G cell phone app for a novel SCD screening information management and communication system SIMCS R21 Phase The App will capture and interpret POC assays capture and maintain a high-fidelity patient ID system serve as a SCD e-passport interface and facilitate SCD pre- and post- test counseling The investigators will iteratively test the feasibility accuracy reproducibility efficacy and robustness of the custom App and SCD SIMCS in our Mulago National Referral Hospital MNRHMakerere University College of Health Sciences MakCHS Sickle Cell Program and affiliated primary health centers in Kampala The goal is to enable a simple error-free reliable and standardized SCD screening using a low-cost POC assay that can be performed across wide ranging health center levels and health worker expertise and facilitate efficient information sharing and coordination between stakeholders
Aim 2 To evaluate the impact of the SCD SIMCS on access to screening and care and outcomes of children with SCD R33 Phase Hypotheses The SCD SIMCS will enable universal SCD screening of infants in participating communities facilitate coordination of their clinical care and result in reduction of morbidity and mortality due to SCD in participating communities The investigators will perform a clustered randomized trial CRT of the SCD SIMCS among health centers in one urban and three rural districts of Uganda The goal is to generate community level evidence on the impact of the SCD SIMCS to inform its adoption and expansion to a national scale in Uganda and adaptation to other LMIC countries
In Phase 1 the investigators will finalize creation of short videos for patient education integrate the modules of the SCD SIMCS 3G cell phone App and test its integration with the Ministry of Health MOH Tier3 data center The investigators will also optimize the analytics and informatics algorithms for data transmitted to the MOH data center Reiterations of improvements and testing to optimize the design and functionalities of the App and SCD SIMCS will be made based on user feedback Phase 1 will be conducted at Mulago National Referral Hospital and later piloted in a sample of health centers in the city of Kampala In Phase 2 the investigators will conduct a Cluster Randomized Trial CRT involving health centers in one urban district Kampala and three rural districts that have established community research infrastructure the Iganga-Mayuge Health Demographic Survey Site IMHDSS and Rakai Health Research Program RHRP
The investigators expect the proposed SCD SIMCS to reduce SCD mortality and morbidity by expanding access to screening facilitating continuity and coordination of care and providing real time data for national SCD policy and planning and research Our team involves stakeholders with the mandate and resources to successfully conduct the proposed research and most critically to integrate and sustain the SCD SIMCS in the health system
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None