NCT07846319
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
Not Yet Recruiting · Not Applicable · epHealth · registry updated 2026-10-02
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
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....
Inclusion
- POPULATION FOR CARE-RELATED DATA: The population will consist of adults registered with municipal Primary Health Care who meet the eligibility criteria for T2DM screening on the index date of each period. In general, the following will be considered potentially eligible: (i) individuals aged 35 years or older; (ii) individuals aged 18 to 34 years with overweight or obesity and at least one risk factor defined in the protocol; (iii) individuals aged 18 years or older presenting certain high-risk conditions. Factors and conditions assessed include cardiovascular disease, dyslipidemia, arterial hypertension, prior laboratory-confirmed prediabetes, prior gestational diabetes, current pregnancy, antipsychotic use, obstructive sleep apnea syndrome, HIV/AIDS, cystic fibrosis, and history of transplantation.
- HEALTHCARE PROFESSIONAL PARTICIPANTS: Professionals will be considered research participants exclusively for the components evaluating educational impact, acceptability, and usability of the strategy. Eligible professionals will be those aged 18 years or older, currently working in the municipality, directly involved in the implementation or operationalization of the strategy, who attend the training corresponding to their role and agree by signing the Informed Consent Form (ICF). Participation in institutional training will not be contingent on participation in the research. Refusal to authorize the use of questionnaire data will not result in any functional, hierarchical, or institutional penalty.
Exclusion
- POPULATION FOR CARE-RELATED DATA: Individuals with prior evidence of diabetes or with recent screening will be excluded, according to the windows and rules defined in the protocol. Criteria were limited to information that could be reliably identified in the structured fields of available data sources. The absence of a record of a given condition will not be interpreted as confirmation of its absence.
- HEALTHCARE PROFESSIONAL PARTICIPANTS: Professionals absent from training sessions due to vacation, leave, medical leave, or any other reason will not be included in the research components related to healthcare professionals.