Structuring of Diabetes Care in Primary Health Care

Hospital de Clinicas de Porto Alegre

Status: Not yet enrolling

Conditions: Diabetes Mellitus, Type 2

Treatments: Other: No intervention; Other: Redistribution of diabetes care between nurses and physicians; Other: Individualized glycemic target; Other: Minimum care recomendations

Study type: Interventional

Funder types: Other

Identifiers

NCT05852626

20220197

64538322.1.0000.5327 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 408 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Exclusion criteria:

• Expected survival < one year

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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408 participants in 2 patient groups

Intervention

Experimental group

Description:

Multimodal intervention in the primary care team that includes: redistribution of diabetes care between nurses and physicians, use of the individualized glycemic target calculator and implementation of minimum care recommendations

Treatment:

Other: Redistribution of diabetes care between nurses and physicians

Other: Individualized glycemic target

Other: Minimum care recomendations

Control

Active Comparator group

Description:

Usual follow-up in Primary Health Care (no intervention in the teams)

Treatment:

Other: No intervention