NCT02811874

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
118

participants targeted

Target at P50-P75 for not_applicable diabetes

Timeline
Completed

Started Feb 2009

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
5.3 years until next milestone

First Submitted

Initial submission to the registry

March 4, 2016

Completed
4 months until next milestone

First Posted

Study publicly available on registry

June 23, 2016

Completed
Last Updated

June 23, 2016

Status Verified

June 1, 2016

Enrollment Period

1.1 years

First QC Date

March 4, 2016

Last Update Submit

June 22, 2016

Conditions

Diabetes

Keywords

diabetes educationcommunity health workersdiabetes control

Outcome Measures

Primary Outcomes (1)

  • HbA1c

    comparison baseline and three months after intervention.

Secondary Outcomes (8)

  • Diabetes literacy

    comparison baseline and three months after intervention.

  • Diastolic Blood pressure

    comparison baseline and three months after intervention.

  • Systolic Blood Pressure

    comparison baseline and three months after intervention.

  • Total cholesterol

    comparison baseline and three months after intervention.

  • HDL-Cholesterol

    comparison baseline and three months after intervention.

  • +3 more secondary outcomes

Study Arms (2)

diabetes education

EXPERIMENTAL

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

Behavioral: diabetes education

education in other areas

ACTIVE COMPARATOR

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

Behavioral: education in other areas

Interventions

diabetes educationBEHAVIORAL

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.

diabetes education
education in other areasBEHAVIORAL

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

education in other areas

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients with diabetes mellitus who live in the community of the health care unit and who agree to participate the study.

You may not qualify if:

  • None.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

Location

UBS São Pedro

Porto Alegre, Rio Grande do Sul, 91570-000, Brazil

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Officials

  • Cristiane Bauermann Leitão, PhD

    HCPA/UFRGS

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2016

First Posted

June 23, 2016

Study Start

February 1, 2009

Primary Completion

March 1, 2010

Study Completion

December 1, 2010

Last Updated

June 23, 2016

Record last verified: 2016-06

Locations

BR(2)