THE 7th EAHSC Usability of redcap in multisite clinical trials in Kilimanjaro, Tanzania Mtesha BA, Ngowi KM, Pima FM, Mmbaga BT, Sumari-de Boer IM.

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Presentation transcript:

THE 7th EAHSC Usability of redcap in multisite clinical trials in Kilimanjaro, Tanzania Mtesha BA, Ngowi KM, Pima FM, Mmbaga BT, Sumari-de Boer IM

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.

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

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

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

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.

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

Material and methods Databases Single participant All participants

Material and methods Data collection & queries management Redcap Queries Data collection

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.

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.

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.

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

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

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