Clinical trial NCT02811874: Community Health Workers and Diabetes Education
Official title: Efficacy of Community Health Workers Education in Diabetes Control: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Keywords: diabetes education
community health workers
diabetes control
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
Collaborators: name: Associação Fundo de Incentivo à Pesquisa
First posted: 2016-06-23
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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).

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.

Eligibility 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.

Primary outcomes:
measure: HbA1c
timeFrame: comparison baseline and three months after intervention.
Secondary outcomes:
measure: Diabetes literacy
timeFrame: comparison baseline and three months after intervention.
measure: Diastolic Blood pressure
timeFrame: comparison baseline and three months after intervention.
measure: Systolic Blood Pressure
timeFrame: comparison baseline and three months after intervention.
measure: Total cholesterol
timeFrame: comparison baseline and three months after intervention.
measure: HDL-Cholesterol
timeFrame: comparison baseline and three months after intervention.
measure: Triglycerides
timeFrame: comparison baseline and three months after intervention.
measure: Height
timeFrame: baseline measure only
measure: Weight
timeFrame: comparison baseline and three months after intervention.
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
state: Rio Grande do Sul
city: Porto Alegre
country: Brazil
facility: UBS São Pedro
state: Rio Grande do Sul
Study officials:
affiliation: HCPA/UFRGS
name: Cristiane Bauermann Leitão, PhD
role: STUDY_DIRECTOR
References: