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Evaluating REDCap Usability in Multisite Clinical Trials in Kilimanjaro, Tanzania

This study assesses the usability of REDCap for managing data in two clinical trials aimed at improving adherence among people living with HIV and TB patients in Kilimanjaro, Tanzania. Challenges included costs, data quality, storage, and GCP compliance. By utilizing REDCap to build an online database for data collection and query management, our findings reveal it to be a feasible solution for nurses, who prefer it over traditional methods. This study advocates for REDCap use in resource-limited settings based on its efficiency and user satisfaction.

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Evaluating REDCap Usability in Multisite Clinical Trials in Kilimanjaro, Tanzania

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  1. THE 7th EAHSCUsability of redcap in multisite clinical trials in Kilimanjaro, Tanzania Mtesha BA, NgowiKM, Pima FM, Mmbaga BT, Sumari-de Boer IM

  2. Introduction • We have two clinical trials. • One trial: conducted to improve adherence among people living with HIV (PLHIV) in Kilimanjaro, Tanzania. • Two Sites involved • KCMC Hospital • Majengo HC • Second trial: Improve adherence by using digital technology among TB patients. • All clusters found in Kilimanjaro region involved.

  3. Challenges facing: TRIALS • Cost: Human resources, transport, paper-printed(CRF) • Data quality-fixing queries, security • Storage: Scalability difficult • GCP compliancy issues

  4. Innovation… • Redcap. • Research electronic data capture. • Building and Managing online database. • Created at Vanderbilt University, 2004. • The software is free. • Login remotely.

  5. Objective. • To determine usability of redcap in two clinical trials in Kilimanjaro, Tanzania.

  6. Material and methods • Redcap used in two clinical trial. • Building database. • Data collection. • Query Management. • Databases set up and Data collection/entry. • DMU of Kilimanjaro Clinical Research Institute (KCRI) • Tablets with android platforms by nurse counselors. • Ethnographic Observation. • We used observation to investigate usability.

  7. Redcap server at KCRI Study site Send Data Download update data Solving queries Research team

  8. Material and methods • Databases • Single participant • All participants

  9. Material and methods • Data collection & queries management • Redcap Queries • Data collection

  10. Results of first trial • Query outcomes • Easy to create and solve query by using Redcap. • We have 260 HIV patients which is ready entered to the database. • Over 3000 queries raised and also solved on time.

  11. Results of first trial • Nurses found use of redcap feasible don’t want to go back to paper. • Only costs are purchasing of tablet. • No programmer involved to build database. • Nurses are satisfied with data entry mode on tablets. • Data can be easily downloaded in different formats for analysis.

  12. Results for second trial • Tuberculosis trial. • Database completed. • Training done. • Nurses are satisfied. • We expected 660 participant in this trial. • 185 Site included. • Forms were developed through different CRF: Screening, Enrolment, Laboratory, Standard consultation, Feedback and stigma.

  13. Discussion • Observation and qualitative method used. • Query management should be possible through tablets. • Save timeand cost. • Quality and security.

  14. Conclusion and Recommendation • Redcap was found usable. • We recommend trials in resource-limited settings to use Redcap.

  15. Acknowledgment • Participants of both sites. • Study teams • Data management Unit of KCRI • Administrative Unit of KCRI • Funders

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