Community Health Workers and Diabetes Education

Not Applicable

Completed

• Conditions: Diabetes
• Interventions: Behavioral: diabetes education; Behavioral: education in other areas

• Registration Number: NCT02811874
• Lead Sponsor: Hospital de Clinicas de Porto Alegre

Brief Summary

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

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.

Study Timeline

• Study Start: 2009-02
• Primary Completion: 2010-03
• Study Completion: 2010-12
• Study First Submitted: 2016-03-04
• Status Verified: 2016-06
• Study First Submitted QC: 2016-06-22
• Last Update Submitted: 2016-06-22
• Study First Posted: 2016-06-23
• Last Update Posted: 2016-06-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 118

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
diabetes education	diabetes education	Four community health workers receive a one-month diabetes education program (intervention group, patients n= 62)
education in other areas	education in other areas	Four community health workers receive an education course in other health issues (control group, patients n= 56).

Primary Outcome Measures

Name	Time	Method
HbA1c	comparison baseline and three months after intervention.

Secondary Outcome Measures

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

Trial Locations

Locations (2)

UBS São Pedro; 🇧🇷 Porto Alegre, Rio Grande do Sul, Brazil

Hospital de Clínicas de Porto Alegre; 🇧🇷 Porto Alegre, Rio Grande do Sul, Brazil