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Completed

NCT Number: NCT02811874

Community Health Workers and Diabetes Education

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).

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Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital de Clínicas de Porto Alegre, Porto Alegre, Rio Grande do Sul, Brazil

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Diabetes education

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

Behavioral

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

Primary outcomes

  1. HbA1c

    Time frame: comparison baseline and three months after intervention.

Secondary outcomes

  1. Diabetes literacy

    Time frame: comparison baseline and three months after intervention.

    measured by a 22 questions questionnaire testing diabetes knowledge

  2. Diastolic Blood pressure

    Time frame: comparison baseline and three months after intervention.

    unit: mmHg

  3. Systolic Blood Pressure

    Time frame: comparison baseline and three months after intervention.

    unit: mmHg

  4. Total cholesterol

    Time frame: comparison baseline and three months after intervention.

    unit: mg/dL

  5. HDL-Cholesterol

    Time frame: comparison baseline and three months after intervention.

    unit: mg/dL

  6. Triglycerides

    Time frame: comparison baseline and three months after intervention.

    unit: mg/dL

  7. Height

    Time frame: baseline measure only

    unit: centimeters; this outcome will be used to calculate Body Mass Index (BMI)

  8. Weight

    Time frame: comparison baseline and three months after intervention.

    unit: kilograms; this outcome will be used to calculate Body Mass Index (BMI)

Sponsors and collaborators

Lead sponsor

Hospital de Clinicas de Porto Alegre

Other

Collaborators

  • Associação Fundo de Incentivo à Pesquisa

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jun 23, 2016
Registry last updated
Jun 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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