NCT02795910

Brief Summary

This study will evaluate a complex intervention based on a patient management tool (PMT), combined with educational outreach to primary care doctors, nurses and other health workers, in the Brazilian city of Florianopolis. The intervention is aimed at improving the quality of primary health care and health outcomes, in adults with diabetes and cardiovascular disease (CVD). The effectiveness of the intervention will be assessed by randomly allocating 48 primary care clinics to receive the intervention or not, and comparing patient and clinic level endpoints that reflect the health and quality of care provided over the following year. About 11000 patients known to have been diagnosed with diabetes mellitus and 32000 with CVD (defined as having a diagnosis of hypertension, ischemic heart disease, heart failure or cerebrovascular disease) in participating clinics will be included in the study. About 7800 of them have diagnoses of both CVD and stroke. The primary endpoints will be 1. Number of participants in whom at least one of the following tests was recorded: body mass index, plasma glucose, serum cholesterol, electrocardiogram, and 2. in participants with a diagnosis of hypertension recorded previously, average systolic blood pressure recorded. Secondary endpoints will include the individual components of the composite scores, health measures (hospital admissions and deaths), and indicators of appropriate diagnosis of comorbid conditions such as depression. Eligible patients will be identified and outcomes measured using electronic medical records.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40,577

participants targeted

Target at P75+ for not_applicable diabetes-mellitus

Timeline
Completed

Started Apr 2017

Typical duration for not_applicable diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 6, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 10, 2016

Completed
10 months until next milestone

Study Start

First participant enrolled

April 1, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2019

Completed
Last Updated

April 30, 2018

Status Verified

April 1, 2018

Enrollment Period

12 months

First QC Date

June 6, 2016

Last Update Submit

April 26, 2018

Conditions

Diabetes MellitusHypertensionHeart FailureIschemic Heart DiseaseCerebrovascular Disease

Outcome Measures

Primary Outcomes (2)

  • Cardiovascular risk and diabetes testing

    Number of participants in whom at least one of the following tests was recorded: body mass index, plasma glucose, glycated hemoglobin (HbA1c), serum cholesterol, electrocardiogram.

    During the first year of the trial

  • Systolic blood pressure

    In participants with a diagnosis of hypertension recorded previously, and with systolic blood pressure \>140 mm Hg recorded during 12 months before start of follow up, average systolic blood pressure recorded

    During the first year of the trial

Secondary Outcomes (25)

  • Diastolic blood pressure

    During the first year of the trial

  • Number of tests

    During the first year of the trial

  • BMI measured

    During the first year of the trial

  • Cholesterol tested

    During the first year of the trial

  • ECG tested

    During the first year of the trial

  • +20 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

Doctors and nurses in each clinic will receive printed copies of the patient management tool (PMT) and outreach education training. First trainers will be trained, then trainers will train groups of doctors and nurses at their workplaces, showing them how to use the guidelines, and using their own patients and clinical problems as examples. This outreach training is repeated several times in short sessions

Behavioral: Outreach education training

Control

ACTIVE COMPARATOR

Doctors and nurses in each clinic will receive printed copies of the patient management tool (PMT) but will receive no outreach education training.

Behavioral: No outreach education training

Interventions

Outreach education trainingBEHAVIORAL

Printed copies of the patient management tool (PMT) and outreach education training

Intervention
No outreach education trainingBEHAVIORAL

Printed copies of the patient management tool (PMT) without outreach education training

Control

Eligibility Criteria

Age35 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 35 years and over in July 2016
  • Diagnosis of hypertension (ICD-10 code I10-I15), ischaemic heart disease (ICD-10 code I20-I25), heart failure (ICD-10 code I50), cerebrovascular disease (ICD-10 code I60-I69), or diabetes mellitus (ICD-10 code E10-E14) ever recorded since January 1st 2010, and attended a participating clinic for any reason during the first year of the trial

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Florianopolis City Health Department

Florianópolis, Santa Catarina, 88.040-400, Brazil

Location

Related Publications (1)

  • Bachmann MO, Bateman ED, Stelmach R, Cruz AA, Pacheco de Andrade M, Zonta R, Zepeda J, Natal S, Cornick R, Wattrus C, Anderson L, Lombard C, Fairall LR. Integrating primary care of chronic respiratory disease, cardiovascular disease and diabetes in Brazil: Practical Approach to Care Kit (PACK Brazil): study protocol for randomised controlled trials. J Thorac Dis. 2018 Jul;10(7):4667-4677. doi: 10.21037/jtd.2018.07.34.

    PMID: 30174920DERIVED

MeSH Terms

Conditions

Diabetes MellitusHypertensionHeart FailureMyocardial IschemiaCerebrovascular Disorders

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesVascular DiseasesCardiovascular DiseasesHeart DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Max Bachmann, MBChB PhD

    University of East Anglia

    PRINCIPAL INVESTIGATOR

  • Eric Bateman, MBChB MD

    University of Cape Town

    PRINCIPAL INVESTIGATOR

  • Rafael Stelmach, MD PhD

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 6, 2016

First Posted

June 10, 2016

Study Start

April 1, 2017

Primary Completion

March 31, 2018

Study Completion

March 31, 2019

Last Updated

April 30, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)