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Structuring of Diabetes Care in Primary Health Care

Structuring Diabetes Care in Primary Health Care With Individualized Goals and Multidisciplinary Integration: A Cluster-randomized Clinical Trial for

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05852626
Enrollment
408
Registered
2023-05-10
Start date
2023-05-31
Completion date
2026-01-31
Last updated
2023-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2

Brief summary

The aim of this study is to evaluate the effectiveness of reorganization in Primary Health Care teams and individualized glycemic targets for type 2 diabetes.

Detailed description

The prevalence of diabetes is increasing in parallel with the obesity epidemic. Diabetes is, therefore, a costly disease for individuals and healthcare system, generating expenses in its management and its complications. Also, it has significant social cost related to reduction of productivity. This study will evaluate the effectiveness of a multimodal intervention for Primary Health Care (PHC) teams to increase the nurse clinical role and implement individualized glycemic targets and care plan for type 2 diabetes through a pragmatic cluster-randomized clinical trial, with 1:1 allocation of health units in Porto Alegre, Brazil. Two study arms will be evaluated: 1) intervention group: will receive a set of proposed actions (redistribution of diabetes care between nurses and physicians, use of the individualized glycemic target calculator and implementation of care recommendations); 2) control group: usual follow-up in PHC.

Interventions

OTHERRedistribution of diabetes care between nurses and physicians

It will be proposed that nurses and physician share the clinical care of patients with type 2 diabetes, with complementing actions

OTHERIndividualized glycemic target

Define the target of individualized glycemic treatment for patients with the support of a tool on the website, which will encourage the intensification and de-intensification of treatment when appropriate

OTHERMinimum care recomendations

It will be proposed to carry out the minimum necessary assessments that, annually, nurses and physicians must do to ensure the adequacy of quality indicators in the care of diabetes in the PHC

OTHERNo intervention

Primary care health teams will follow their rotine care of type 2 diabetes

Sponsors

Conselho Nacional de Desenvolvimento Científico e Tecnológico
CollaboratorOTHER_GOV
Hospital de Clinicas de Porto Alegre
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

Cluster randomized clinical trial

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Health care unit: Inclusion criteria * Health unit has registered at least 50 users diagnosed with type 2 diabetes

Exclusion criteria

* Health units that do not have a doctor and a nurse available on the same shift or do not have at least one doctor and a nurse willing to participate in the study. Individuals: Inclusion criteria * Individuals with type 2 diabetes for at least one year * In person diabetes consultation in the last six months

Design outcomes

Primary

MeasureTime frameDescription
Number of patients who achieved individualized target HbA1c12 monthsNumber of patients who achieved the individualized target HbA1c defined at baseline

Secondary

MeasureTime frameDescription
Percentage of clinical consultations carried out by nurses12 monthsProportion of nursing consultations in relation to the total number of consultations (nurse and physician)
Foot evaluation12 monthsTotal number of nursing consultations in which the feet were evaluated

Countries

Brazil

Contacts

Primary ContactBeatriz Schaan
bschaan@hcpa.edu.br+555133598127
Backup ContactAna Matzenbacher
anammatz@hotmail.com+555133598127

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026