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| ID | Type | Description | Link |
|---|---|---|---|
| 64538322.1.0000.5327 | Registry Identifier | Research ethics committee |
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| Name | Class |
|---|---|
| Conselho Nacional de Desenvolvimento CientÃfico e Tecnológico | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | 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 |
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| Control | Active Comparator | Usual follow-up in Primary Health Care (no intervention in the teams) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Redistribution of diabetes care between nurses and physicians | Other | It will be proposed that nurses and physician share the clinical care of patients with type 2 diabetes, with complementing actions |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients who achieved individualized target HbA1c | Number of patients who achieved the individualized target HbA1c defined at baseline | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Foot evaluation |
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Health care unit:
Inclusion criteria
Exclusion criteria:
Individuals:
Inclusion criteria
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Beatriz Schaan | Contact | +555133598127 | bschaan@hcpa.edu.br | |
| Ana Matzenbacher | Contact | +555133598127 | anammatz@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Beatriz Schaan | UFRGS e HCPA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ana Maria Frölich Matzenbacher | Porto Alegre | Rio Grande do Sul | 90035003 | Brazil |
The data will be available from principal investigator upon reasonable request.
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D010820 | Physicians |
| ID | Term |
|---|---|
| D006282 | Health Personnel |
| D005159 | Health Care Facilities Workforce and Services |
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Cluster randomized clinical trial
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| Individualized glycemic target | 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 |
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| Minimum care recomendations | 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 |
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| No intervention | Other | Primary care health teams will follow their rotine care of type 2 diabetes |
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Total number of nursing consultations in which the feet were evaluated
| 12 months |
| D004700 | Endocrine System Diseases |