Community Health Workers and Diabetes Education

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02811874
• Other study ID #: 09-069
• Status: Completed
• Phase: N/A
• First received: March 4, 2016
• Last updated: June 22, 2016
• Start date: February 2009
• Est. completion date: December 2010

Study information

• Verified date: June 2016
• Source: Hospital de Clinicas de Porto Alegre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: December 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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:

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus

Intervention

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

Locations

Country	Name	City	State
Brazil	Hospital de Clínicas de Porto Alegre	Porto Alegre	Rio Grande do Sul
Brazil	UBS São Pedro	Porto Alegre	Rio Grande do Sul

Sponsors (2)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre	Associação Fundo de Incentivo à Pesquisa

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c		comparison baseline and three months after intervention.	No
Secondary	Diabetes literacy	measured by a 22 questions questionnaire testing diabetes knowledge	comparison baseline and three months after intervention.	No
Secondary	Diastolic Blood pressure	unit: mmHg	comparison baseline and three months after intervention.	No
Secondary	Systolic Blood Pressure	unit: mmHg	comparison baseline and three months after intervention.	No
Secondary	Total cholesterol	unit: mg/dL	comparison baseline and three months after intervention.	No
Secondary	HDL-Cholesterol	unit: mg/dL	comparison baseline and three months after intervention.	No
Secondary	Triglycerides	unit: mg/dL	comparison baseline and three months after intervention.	No
Secondary	Height	unit: centimeters; this outcome will be used to calculate Body Mass Index (BMI)	baseline measure only	No
Secondary	Weight	unit: kilograms; this outcome will be used to calculate Body Mass Index (BMI)	comparison baseline and three months after intervention.	No