Community Health Workers and Diabetes Education

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

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).

Study Overview

• Status: Completed
• Conditions: Diabetes
• Intervention / Treatment: Behavioral: diabetes education; Behavioral: education in other areas

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 Type: Interventional
• Enrollment (Actual): 118
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Rio Grande do Sul
    • Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
      • Hospital De Clinicas De Porto Alegre
    • Porto Alegre, Rio Grande do Sul, Brazil, 91570-000
      • UBS São Pedro

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: diabetes education; Four community health workers receive a one-month diabetes education program (intervention group, patients n= 62)	Behavioral: 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.
Active Comparator: education in other areas; Four community health workers receive an education course in other health issues (control group, patients n= 56).	Behavioral: education in other areas; Four theoretical sessions related to education in other health areas, not related to diabetes, administered during 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Collaborators and Investigators

• Sponsor: Hospital de Clinicas de Porto Alegre
• Collaborators: Associação Fundo de Incentivo à Pesquisa
• Investigators: Study Director: Cristiane Bauermann Leitão, PhD, HCPA/UFRGS

Study record dates

Study Major Dates

• Study Start: February 1, 2009
• Primary Completion (Actual): March 1, 2010
• Study Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: March 4, 2016
• First Submitted That Met QC Criteria: June 22, 2016
• First Posted (Estimate): June 23, 2016

Study Record Updates

• Last Update Posted (Estimate): June 23, 2016
• Last Update Submitted That Met QC Criteria: June 22, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: community health workers; diabetes control; diabetes education
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: 09-069

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED