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Evaluation of the Effectiveness of Implementing a Screening Strategy for the Diagnosis of Prediabetes and Type 2 Diabetes Mellitus in Primary Health Care in a Brazilian Municipality (ARISE)

Single-arm Intervention Study With Historical Comparator to Evaluate the Effectiveness of Implementing a Screening Strategy for the Diagnosis of Prediabetes and Type 2 Diabetes Mellitus in Primary Health Care in a Brazilian Municipality

Sponsor
epHealth (Industry)
Enrolment
45,000 planned
Conditions
Diabetes Mellitus (Type 2); Prediabetes
Interventions
ARISE Strategy
Ages
adults, older adults
Registry
NCT07846319

From the registry

Primary objective: To evaluate the effectiveness of the ARISE strategy on the proportion of individuals with confirmed T2DM diagnosis, per protocol criteria based on the PCDT-DM2 (Clinical Protocol and Therapeutic Guidelines for T2DM), among adults eligible for screening registered at UBS (Primary Health Care Units) in Afogados da Ingazeira, during the 12 months post-implementation, compared to a reference value estimated from a historical 12-month period in the same municipality. Methodology: Pragmatic, quasi-experimental, single-arm effectiveness and implementation study with a historical comparator. In each period, the analytic population will be defined by eligibility on the respective index date. In the historical period, data will estimate the reference proportion of the primary outcome and historical values of applicable secondary outcomes. In the post-intervention period, individuals eligible on the index date will be followed for 12 months via care records. Individuals who become eligible after the post-intervention index date may receive care actions under the strategy…

Primary outcomes

  • Proportion of individuals with confirmed diagnosis of type 2 diabetes mellitus (T2DM)
Full record on ClinicalTrials.gov