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Structuring of Diabetes Care in Primary Health Care

Primary Purpose

Diabetes Mellitus, Type 2

Status

Not yet recruiting

Phase

Not Applicable

Locations

Brazil

Study Type

Interventional

Intervention

Redistribution of diabetes care between nurses and physicians

Individualized glycemic target

Minimum care recomendations

No intervention

About this trial

This is an interventional health services research trial for Diabetes Mellitus, Type 2

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Ana Maria Frölich Matzenbacher

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention

Control

Arm 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

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

Outcomes

Primary Outcome Measures

Number of patients who achieved individualized target HbA1c

Number of patients who achieved the individualized target HbA1c defined at baseline

Secondary Outcome Measures

Percentage of clinical consultations carried out by nurses

Proportion of nursing consultations in relation to the total number of consultations (nurse and physician)

Foot evaluation

Total number of nursing consultations in which the feet were evaluated

Full Information

NCT ID

NCT05852626

First Posted

May 2, 2023

Last Updated

May 2, 2023

Sponsor

Hospital de Clinicas de Porto Alegre

Collaborators

Conselho Nacional de Desenvolvimento Científico e Tecnológico

1. Study Identification

Unique Protocol Identification Number

NCT05852626

Brief Title

Structuring of Diabetes Care in Primary Health Care

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

May 2023 (Anticipated)

Primary Completion Date

December 2025 (Anticipated)

Study Completion Date

January 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hospital de Clinicas de Porto Alegre

Collaborators

Conselho Nacional de Desenvolvimento Científico e Tecnológico

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Cluster randomized clinical trial

Masking

None (Open Label)

Allocation

Randomized

Enrollment

408 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Intervention

Arm Type

Experimental

Arm Description

Arm Title

Control

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Redistribution of diabetes care between nurses and physicians

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Individualized glycemic target

Intervention Description

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

Intervention Name(s)

Minimum care recomendations

Intervention Description

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

Intervention Name(s)

No intervention

Intervention Description

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

Primary Outcome Measure Information:

Title

Number of patients who achieved individualized target HbA1c

Description

Number of patients who achieved the individualized target HbA1c defined at baseline

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Percentage of clinical consultations carried out by nurses

Description

Proportion of nursing consultations in relation to the total number of consultations (nurse and physician)

Time Frame

12 months

Title

Foot evaluation

Description

Total number of nursing consultations in which the feet were evaluated

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Beatriz Schaan

Phone

+555133598127

bschaan@hcpa.edu.br

First Name & Middle Initial & Last Name or Official Title & Degree

Ana Matzenbacher

Phone

+555133598127

anammatz@hotmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Beatriz Schaan

Organizational Affiliation

UFRGS e HCPA

Official's Role

Principal Investigator

Facility Information:

Facility Name

Ana Maria Frölich Matzenbacher

City

Porto Alegre

State/Province

Rio Grande Do Sul

ZIP/Postal Code

90035003

Country

Brazil

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ana MF Matzenbacher

anammatz@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

The data will be available from principal investigator upon reasonable request.

Learn more about this trial

Structuring of Diabetes Care in Primary Health Care

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