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Community Health Workers and Diabetes Education

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ClinicalTrials.gov Identifier: NCT02811874
Recruitment Status : Completed
First Posted : June 23, 2016
Last Update Posted : June 23, 2016
Sponsor:
Collaborator:
Associação Fundo de Incentivo à Pesquisa
Information provided by (Responsible Party):
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).


Condition or disease Intervention/treatment Phase
Diabetes Behavioral: diabetes education Behavioral: education in other areas Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 118 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Supportive Care
Official Title: Efficacy of Community Health Workers Education in Diabetes Control: A Randomized Clinical Trial
Study Start Date : February 2009
Actual Primary Completion Date : March 2010
Actual Study Completion Date : December 2010

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




Primary Outcome Measures :
  1. HbA1c [ Time Frame: comparison baseline and three months after intervention. ]

Secondary Outcome Measures :
  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)



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02811874


Locations
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Brazil
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
UBS São Pedro
Porto Alegre, Rio Grande do Sul, Brazil, 91570-000
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Associação Fundo de Incentivo à Pesquisa
Investigators
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Study Director: Cristiane Bauermann Leitão, PhD HCPA/UFRGS
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Responsible Party: Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT02811874    
Other Study ID Numbers: 09-069
First Posted: June 23, 2016    Key Record Dates
Last Update Posted: June 23, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Hospital de Clinicas de Porto Alegre:
diabetes education
community health workers
diabetes control
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases