DiabetesNCT02811874
Community Health Workers and Diabetes Education
A study testing diabetes education and education in other areas in people with Diabetes, run by Hospital de Clinicas de Porto Alegre at 2 sites in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Diabetes
- What is being tested?
- diabetes education and education in other areas
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 2 sitesBrazil
- Study dates
- Feb 2009to Dec 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients with diabetes mellitus who live in the community of the health care unit and who agree to participate the study.
Who cannot join
- None.
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903
UBS São Pedro
Porto Alegre, Rio Grande do Sul, 91570-000
About this study
Official title: Efficacy of Community Health Workers Education in Diabetes Control: A Randomized Clinical Trial
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).
Read the 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.
- Conditions
- Diabetes
- Being tested
- diabetes education, education in other areas
- Keywords
- diabetes education, community health workers, diabetes control
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diabetes educationBehavioural
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 areasBehavioural
Four theoretical sessions related to education in other health areas, not related to diabetes, administered during 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| diabetes education | Experimental | Four community health workers receive a one-month diabetes education program (intervention group, patients n= 62) Receives: 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). Receives: Behavioral: education in other areas |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
Measured: comparison baseline and three months after intervention.
Secondary outcomes (8)
Diabetes literacy
measured by a 22 questions questionnaire testing diabetes knowledge
Measured: comparison baseline and three months after intervention.
Diastolic Blood pressure
unit: mmHg
Measured: comparison baseline and three months after intervention.
Systolic Blood Pressure
unit: mmHg
Measured: comparison baseline and three months after intervention.
Total cholesterol
unit: mg/dL
Measured: comparison baseline and three months after intervention.
HDL-Cholesterol
unit: mg/dL
Measured: comparison baseline and three months after intervention.
Triglycerides
unit: mg/dL
Measured: comparison baseline and three months after intervention.
Height
unit: centimeters; this outcome will be used to calculate Body Mass Index (BMI)
Measured: baseline measure only
Weight
unit: kilograms; this outcome will be used to calculate Body Mass Index (BMI)
Measured: comparison baseline and three months after intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2016 (estimated)
- Study startFeb 2009
- Primary completionMar 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Collaborators
- Associação Fundo de Incentivo à Pesquisa
- Responsible party
- Sponsor
- Investigators
- Cristiane Bauermann Leitão, PhD, Study director, HCPA/UFRGS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02811874
- Sponsor's protocol ID
- 09-069
- Status last verified
- Jun 2016
- First submitted
- 4 Mar 2016
- Last updated
- 23 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Community Health Workers Education in Diabetes Control: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02811874
- Acronym / sponsor ID
- 09-069
- Conditions
- Diabetes
- Keywords
- diabetes education, community health workers, diabetes control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Collaborators
- Associação Fundo de Incentivo à Pesquisa
- Study start
- Feb 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 23 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| diabetes education | Experimental | Behavioral: diabetes educationFour community health workers receive a one-month diabetes education program (intervention group, patients n= 62) |
| education in other areas | Active comparator | Behavioral: education in other areasFour community health workers receive an education course in other health issues (control group, patients n= 56). |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients with diabetes mellitus who live in the community of the health care unit and who agree to participate the study.
Key exclusion criteria (1 listed)
- None.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| diabetes educationDiabetes 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. | Behavioural | diabetes education |
| education in other areasFour theoretical sessions related to education in other health areas, not related to diabetes, administered during 4 weeks | Behavioural | education in other areas |
Primary outcome
HbA1c
Time frame: comparison baseline and three months after intervention.
8 secondary outcomes
Diabetes literacy
Time frame: comparison baseline and three months after intervention.
Diastolic Blood pressure
Time frame: comparison baseline and three months after intervention.
Systolic Blood Pressure
Time frame: comparison baseline and three months after intervention.
Total cholesterol
Time frame: comparison baseline and three months after intervention.
HDL-Cholesterol
Time frame: comparison baseline and three months after intervention.
Triglycerides
Time frame: comparison baseline and three months after intervention.
Height
Time frame: baseline measure only
Weight
Time frame: comparison baseline and three months after intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2016.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cristiane Bauermann Leitão, PhD study director
HCPA/UFRGS
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing diabetes education and education in other areas in people with Diabetes, run by Hospital de Clinicas de Porto Alegre at 2 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c (time frame: comparison baseline and three months after intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2016.