Structuring of Diabetes Care in Primary Health Care

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05852626
• Other study ID #: 20220197
• Secondary ID: 64538322.1.0000.
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2023
• Est. completion date: January 2026

Study information

• Verified date: May 2023
• Source: Hospital de Clinicas de Porto Alegre
• Contact: Beatriz Schaan
• Phone: +555133598127
• Email: bschaan[@]hcpa.edu.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 408
• Est. completion date: January 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Other:
• Redistribution 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
• Individualized 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
• Minimum 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
• No intervention
Primary care health teams will follow their rotine care of type 2 diabetes

Locations

Country	Name	City	State
Brazil	Ana Maria Frölich Matzenbacher	Porto Alegre	Rio Grande Do Sul

Sponsors (2)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre	Conselho Nacional de Desenvolvimento Científico e Tecnológico

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients who achieved individualized target HbA1c	Number of patients who achieved the individualized target HbA1c defined at baseline	12 months
Secondary	Percentage of clinical consultations carried out by nurses	Proportion of nursing consultations in relation to the total number of consultations (nurse and physician)	12 months
Secondary	Foot evaluation	Total number of nursing consultations in which the feet were evaluated	12 months