Community Health Workers and Diabetes Education

NCT ID: NCT02811874

Last Updated: 2016-06-23

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

COMPLETED

Clinical Phase

NA

Total Enrollment

118 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2010-12-31

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.

Conditions

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Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Caregivers

Study Groups

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diabetes education

Four community health workers receive a one-month diabetes education program (intervention group, patients n= 62)

Group Type EXPERIMENTAL

diabetes education

Intervention Type BEHAVIORAL

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.

education in other areas

Four community health workers receive an education course in other health issues (control group, patients n= 56).

Group Type ACTIVE_COMPARATOR

education in other areas

Intervention Type BEHAVIORAL

Four theoretical sessions related to education in other health areas, not related to diabetes, administered during 4 weeks

Interventions

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diabetes education

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.

Intervention Type BEHAVIORAL

education in other areas

Four theoretical sessions related to education in other health areas, not related to diabetes, administered during 4 weeks

Intervention Type BEHAVIORAL

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Associação Fundo de Incentivo à Pesquisa

OTHER

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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Cristiane Bauermann Leitão, PhD

Role: STUDY_DIRECTOR

HCPA/UFRGS

Locations

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Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

UBS São Pedro

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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09-069

Identifier Type: -

Identifier Source: org_study_id

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