Structuring of Diabetes Care in Primary Health Care

NCT ID: NCT05852626

Last Updated: 2023-05-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

408 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-31

Study Completion Date

2026-01-31

Brief Summary

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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

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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.

Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Cluster randomized clinical trial
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Intervention

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

Group Type EXPERIMENTAL

Redistribution of diabetes care between nurses and physicians

Intervention Type OTHER

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

Individualized glycemic target

Intervention Type OTHER

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

Intervention Type OTHER

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

Control

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

Group Type ACTIVE_COMPARATOR

No intervention

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

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

Intervention Type OTHER

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

Intervention Type OTHER

No intervention

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Health unit has registered at least 50 users diagnosed with type 2 diabetes


* Individuals with type 2 diabetes for at least one year
* In person diabetes consultation in the last six months

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:


* Expected survival \< one year
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Conselho Nacional de Desenvolvimento Científico e Tecnológico

OTHER_GOV

Sponsor Role collaborator

Hospital de Clinicas de Porto Alegre

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Beatriz Schaan

Role: PRINCIPAL_INVESTIGATOR

UFRGS e HCPA

Locations

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Ana Maria Frölich Matzenbacher

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Countries

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Brazil

Central Contacts

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Beatriz Schaan

Role: CONTACT

+555133598127

Ana Matzenbacher

Role: CONTACT

+555133598127

Facility Contacts

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Ana MF Matzenbacher

Role: primary

Other Identifiers

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64538322.1.0000.5327

Identifier Type: REGISTRY

Identifier Source: secondary_id

20220197

Identifier Type: -

Identifier Source: org_study_id

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