Structuring of Diabetes Care in Primary Health Care

Not Applicable

Not yet recruiting

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Other: Redistribution of diabetes care between nurses and physicians; Other: No intervention; Other: Individualized glycemic target; Other: Minimum care recomendations

• Registration Number: NCT05852626
• Lead Sponsor: Hospital de Clinicas de Porto Alegre

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.

Study Timeline

• Status Verified: 2023-05
• Study Start: 2023-05
• Study First Submitted: 2023-05-02
• Study First Submitted QC: 2023-05-02
• Last Update Submitted: 2023-05-02
• Study First Posted: 2023-05-10
• Last Update Posted: 2023-05-10
• Primary Completion: 2025-12
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 408

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Redistribution of diabetes care between nurses and physicians	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
Intervention	Individualized glycemic target	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
Control	No intervention	Usual follow-up in Primary Health Care (no intervention in the teams)
Intervention	Minimum care recomendations	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

Primary Outcome Measures

Name	Time	Method
Number of patients who achieved individualized target HbA1c	12 months	Number of patients who achieved the individualized target HbA1c defined at baseline

Secondary Outcome Measures

Name	Time	Method
Percentage of clinical consultations carried out by nurses	12 months	Proportion of nursing consultations in relation to the total number of consultations (nurse and physician)
Foot evaluation	12 months	Total number of nursing consultations in which the feet were evaluated

Trial Locations

Locations (1)

Ana Maria Frölich Matzenbacher; 🇧🇷 Porto Alegre, Rio Grande Do Sul, Brazil