Community Health Workers and Diabetes Education

Study Overview
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Brief Summary
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The aim of this study is to evaluate the effect of a diabetes education program delivered to CHW in improving the metabolic control of patients with type 2 DM. The study is a randomized controlled trial conducted in a primary care unit. Eight CHW, providing care for 118 patients, are randomized in two groups to receive a one-month diabetes education program (intervention group, patients n= 62) or an education course in other health issues (control group, patients n= 56).

Detailed Description
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Background: In Brazil, community health workers (CHW) are members of the community hired by the government to provide education and care for patients for a broad range of health issues, including diabetes mellitus (DM). However, few CHW are trained for diabetes education and little is known about the effectiveness of their interventions. The aim of this study is to evaluate the effect of a diabetes education program delivered to CHW in improving the metabolic control of patients with type 2 DM. Materials and methods: the study is a randomized controlled trial conducted in a primary care unit. Eight CHW, providing care for 118 patients, are randomized in two groups to receive a one-month diabetes education program (intervention group, patients n= 62) or an education course in other health issues (control group, patients n= 56). Each CHW is responsible for transmitting the acquired knowledge to patients from their respective working areas. The primary outcome is change in HbA1C three months after intervention.

Official Title
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Efficacy of Community Health Workers Education in Diabetes Control: A Randomized Clinical Trial

Conditions
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Diabetes

Intervention / Treatment
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* Behavioral: diabetes education
* Behavioral: education in other areas


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients with diabetes mellitus who live in the community of the health care unit and who agree to participate the study. Exclusion Criteria: None.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: diabetes education<br>Four community health workers receive a one-month diabetes education program (intervention group, patients n= 62) | Behavioral: diabetes education<br>* Diabetes education program includes: 4 theoretical sessions, 60 minutes long, taught once a week for 4 weeks, developed in the form of group classes, and given by one of the authors. The educational program content comprises (1) definition of diabetes, and identification of modifiable risk factors for type 2 diabetes, (2) non-pharmacological treatment, with emphasis on diet and exercise, (3) pharmacological therapy, including mechanism of action and side effects of anti-diabetic medications provided by the Brazilian public health system and (4) an overview of chronic diabetes complications.<br>|
| Active Comparator: education in other areas<br>Four community health workers receive an education course in other health issues (control group, patients n= 56). | Behavioral: education in other areas<br>* Four theoretical sessions related to education in other health areas, not related to diabetes, administered during 4 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c |  | comparison baseline and three months after intervention. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diabetes literacy | measured by a 22 questions questionnaire testing diabetes knowledge | comparison baseline and three months after intervention. | 
| Diastolic Blood pressure | unit: mmHg | comparison baseline and three months after intervention. | 
| Systolic Blood Pressure | unit: mmHg | comparison baseline and three months after intervention. | 
| Total cholesterol | unit: mg/dL | comparison baseline and three months after intervention. | 
| HDL-Cholesterol | unit: mg/dL | comparison baseline and three months after intervention. | 
| Triglycerides | unit: mg/dL | comparison baseline and three months after intervention. | 
| Height | unit: centimeters; this outcome will be used to calculate Body Mass Index (BMI) | baseline measure only | 
| Weight | unit: kilograms; this outcome will be used to calculate Body Mass Index (BMI) | comparison baseline and three months after intervention. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes education, community health workers, diabetes control