Digital App for Sickle Cell Disease Screening

(SIMCS SCD Trial)

Not yet recruiting at 1 trial location

Overseen By Nelson K Sewankambo, MBChB, MMed

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Makerere University

Disqualifiers: Age 1 year or older

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new digital app designed to improve sickle cell disease (SCD) screening for infants in Uganda. By streamlining how health centers manage and share screening information, the app could facilitate early detection of SCD and ensure timely care for children. Infants under one year of age who visit selected health centers will participate in the trial. The study compares outcomes between centers using the app and those employing traditional methods to determine if the app enhances accurate screenings and timely care. As an unphased trial, this study provides a unique opportunity to contribute to innovative healthcare solutions for infants.

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 prior data suggests that this digital app and information system is safe for SCD screening?

Research has shown that mobile apps for sickle cell disease (SCD) can improve patient health. For instance, one app tested in early studies reduced emergency visits for people with SCD, indicating its potential usefulness in managing the condition. However, specific safety information about the app used in this trial is not available.

The trial is in a "Not Applicable" phase, focusing on improving the app rather than testing a new drug. This suggests a likely low risk, as it uses existing technology. The app is designed to assist with SCD screening and management, facilitating healthcare workers in tracking and sharing patient information. Although direct safety data is lacking, the app's digital nature generally suggests safety in use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the digital app for sickle cell disease screening because it introduces a tech-savvy way to enhance early diagnosis and care. Unlike traditional methods, which rely heavily on manual interpretation of test results and follow-up procedures, this app automatically transmits data and tracks outcomes, potentially reducing errors and speeding up the process. By empowering health workers with a digital tool that provides instant data analysis and connectivity, the app could improve the accuracy of diagnoses and ensure that infants receive timely care, making a significant difference in managing sickle cell disease.

What evidence suggests that this digital app and information system is effective for SCD screening?

Research shows that digital apps can significantly aid in managing sickle cell disease (SCD) by facilitating patient involvement in their care and access to medical services. In this trial, one group of hospitals will use a smartphone app, the SCD SIMCS app, to assist in accurately diagnosing SCD and managing patient care. This method effectively identifies sickle cells, the abnormal red blood cells characteristic of this disease. Another group of hospitals will not use the app but will still use smartphones to capture and send test results. Health apps on phones have proven to help patients adhere to their treatment plans more effectively. Overall, these tools promise improved and more organized care for people with SCD, potentially leading to better health by simplifying testing and follow-up care. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

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

I am enrolling my infant who is under 1 year old.

Exclusion Criteria

I am at least 1 year old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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)

Phase 1: Conducted at Mulago National Referral Hospital and piloted in Kampala

Multiple visits for app development and testing

Cluster Randomized Trial

Conduct a Cluster Randomized Trial (CRT) involving health centers in one urban district (Kampala) and three rural districts

Phase 2: Two years

Regular visits for data collection and monitoring

Follow-up

Participants are monitored for safety and effectiveness after the implementation of the SCD SIMCS

Two years

What Are the Treatments Tested in This Trial?

Interventions

• Digital app and information system

Trial Overview The trial is testing a custom mobile app designed for managing SCD screening data. The goal is to evaluate how this digital system affects access to screening services, continuity of care, and clinical outcomes for children with SCD.

How Is the Trial Designed?

Group I: App/digital system Experimental Treatment 1 Intervention

Experimental Hospital/HCs will be provided with point of care test kits and smart phones loaded with airtime credit and the SCD SIMCS app. The health workers that normally provide pediatric care at the facilities will be trained in using the kits and SCD SIMCS app. Outcome measures to compare the effectiveness of SCD screening with and without the SIMCS will include proportions of accurately interpreted assay results, parents that receive counseling, infants seen for SCD care within 1 month of screening, and infants on penicillin. Variables to compute these outcome measures will be entered into cellphone eCRFs (Controls) or automatically transmitted from the SCD SIMCS App (Experimental) and retrieved from the SCD SIMCS database. Chi-squared test and contingent 95% confidence intervals and p-values will be computed to compare the proportions between SIMCS vs. non-SIMCS hospital/HCs.

Group II: No App/digital system Active Control 1 Intervention

Control Hospital/HCs will be provided with point of care test kits and smart phones loaded with airtime credit BUT no SCD SIMCS app. The health workers that normally provide pediatric care at the facilities will be trained in using the kits. To enable independent verification of the accuracy of interpretation of assay results, health workers will use the smart phones to take and send a photographic caption of every used point of care test strip to a designated central study phone from which they will be downloaded into a computer database. Control infants will be IDed by study number in the SCD SIMCS database.

Who Is Running the Clinical Trial?

Makerere University

Lead Sponsor

Trials

297

Recruited

1,862,000+

Ministry of Health, Uganda

Collaborator

Trials

36

Recruited

1,380,000+

Baylor College of Medicine

Collaborator

Trials

1,044

Recruited

6,031,000+

Published Research Related to This Trial

The study assessed the feasibility of the Voice Crisis Alert V2 mobile health application for self-management in children with sickle cell disease (SCD), involving 60 child-caregiver dyads and achieving 82% retention by the end of the intervention.

High satisfaction was reported among users, with 94% of dyads engaging with the app during the intervention, primarily for tracking health history and symptoms, although challenges with sustained use were noted post-intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of an mHealth self-management intervention for children and adolescents with sickle cell disease and their families. Phillips, S., Kanter, J., Mueller, M., et al.[2022]

A feasibility randomized controlled trial involving 67 adults with sickle cell disease (SCD) showed high recruitment (91%) and retention (75%) rates for a mobile health app designed to improve patient knowledge and potentially reduce hospitalizations.

All participants in the treatment group used the mHealth app, indicating strong adherence to the intervention, which suggests that mobile health tools can be effectively integrated into patient care for SCD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A feasibility randomized controlled trial of an mHealth app vs booklets for patient-facing guidelines in adults with SCD. Cronin, RM., Quaye, N., Liu, X., et al.[2023]

The Intensive Training Program (ITP) mobile health intervention significantly improved medication adherence and disease knowledge among 32 youth with sickle cell disease over a 90-day period, with adherence rates increasing from 0.57 to 0.74 (P < 0.001).

Participants who completed the ITP showed better SCD-related functioning and lower pain impact compared to those who did not complete the program, highlighting the importance of engagement in achieving positive health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile health intervention for youth with sickle cell disease: Impact on adherence, disease knowledge, and quality of life. Anderson, LM., Leonard, S., Jonassaint, J., et al.[2019]

A study involving 26 adolescents and young adults with sickle cell disease showed that using a mobile health app (iManage for SCD) can improve self-management skills and self-efficacy, especially for those who engage frequently with the app.

Increased app engagement was linked to better mood ratings and lower pain levels, suggesting that mobile health tools can be effective in helping young people manage their condition more effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile health use predicts self-efficacy and self-management in adolescents with sickle cell disease. Hood, AM., Nwankwo, C., Walton, A., et al.[2022]

A study involving 46 adolescents and young adults (AYAs) with sickle cell disease (SCD) found that 69% had daily Internet access, indicating a strong potential for mobile health interventions.

The co-designed mobile app prototype, iManage, was rated as highly feasible and beneficial, suggesting it could effectively engage AYAs in self-management strategies to improve their health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and evaluation of iManage: A self-management app co-designed by adolescents with sickle cell disease. Crosby, LE., Ware, RE., Goldstein, A., et al.[2022]

The SMART app demonstrated high feasibility for monitoring pain in sickle cell disease patients, with a median compliance rate of 75% over 28 days, indicating that patients found it useful for tracking their symptoms.

There was a strong correlation between pain severity reported by patients and their pain intensity measurements using the app, suggesting that SMART effectively captures the patients' experiences of pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Usability and Feasibility of an mHealth Intervention for Monitoring and Managing Pain Symptoms in Sickle Cell Disease: The Sickle Cell Disease Mobile Application to Record Symptoms via Technology (SMART). Jonassaint, CR., Shah, N., Jonassaint, J., et al.[2022]

Citations

1. reporter.nih.gov reporter.nih.gov/search/EaC3BhVN6USBfOMuTswDVQ/project-details/11084364

Project Details - NIH RePORTER 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 ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04678037

Home-based Assessment of PRO Measures in SCD Using ... A smartphone app platform designed for patients with sickle cell disease. The SCD-app is programmed to send notification to patients to complete PROs assessment ...

3. meddatax.com meddatax.com/clinical-trials/NCT06563440

Development and Evaluation of an Information Management ... 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 ...

4. bmcdigitalhealth.biomedcentral.com bmcdigitalhealth.biomedcentral.com/articles/10.1186/s44247-024-00138-0

Factors influencing engagement with adherence-enhancing ... Factors influencing engagement with adherence-enhancing mobile health app in sickle cell disease. Christina M Abrams,; Natalia Davila, ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7244537/

Automated screening of sickle cells using a smartphone- ... Our results and analysis demonstrate that the presented method, enabled by smartphone microscopy and deep learning, is robust to perform SCD diagnosis by ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12161614/

Usage of a Multipurpose mHealth App Among Adults With ... A multipurpose app can help engage participants in self-management strategies through different features and potentially improve outcomes.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7484220/

Smartphone-based Sickle Cell Disease Detection and ... In this article, we utilized a smartphone-based image acquisition method for capturing RBC images from the SCD patients in normoxia and hypoxia conditions.

8. digital.ahrq.gov digital.ahrq.gov/ahrq-funded-projects/use-mobile-technology-improve-acute-care-utilization-sickle-cell-disease

Use of Mobile Technology To Improve Acute Care Utilization ... This research pilot tested a sickle cell disease mobile application that was found to reduce acute care visits by patients with the condition.

9. withpower.com withpower.com/trial/phase-anemia-sickle-cell-9-2023-3367b

Web-Based App for Sickle Cell Disease Is the web-based app for sickle cell disease safe for humans? There is no specific safety data available for the web-based app for sickle cell disease or its ...