Pharmaceutical Care in Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine the effect of a pharmaceutical care program on the level of glycated hemoglobin for hyperglycemic users of brazilian public health care system in drug treatment for type 2 diabetes.

Detailed Description
-----------------
The chronic diseases, including diabetes mellitus (DM) are a major public health problems of today. There is evidence that glycated hemoglobin (A1C) levels above 7% are associated with a progressively greater risk of chronic complications related to DM. However, approximately 60% of diabetics do not achieve glycemic control. In Brazil, pharmacists are not involved in direct care of patients with DM. The investigators conducted a randomized controlled trial, for six months, in Ouro Preto, Minas terais to determine the effect of pharmaceutical intervention on glycemic control in patients with diabetes and hyperglycemic (A1C > 7%). One hundred and twenty-nine subjects were randomized to receive usual care only or usual care and pharmaceutical intervention. The population of those who had access in the brazilian public health care system, as consultations with doctors, nurses and nutritionists, laboratory tests and access to essential medicines were considered as conventional health care.

Official Title
-----------------
Pharmaceutical Care Program for Users of Brazilian Public Health Care System With Type 2 Diabetes Mellitus: Randomized Controlled Clinical Trial

Conditions
-----------------
DIABETES MELLITUS, TYPE 2

Intervention / Treatment
-----------------
* Other: PHARMACEUTICAL CARE
* Other: HEALTH USUAL CARE


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: MINIMAL AGE 18 YEARS OLD USE OF DIABETES ORAL MEDICATION MINIMAL GLYCOHEMOGLOBIN 7% Exclusion Criteria: PREGNANT AND NURSING WOMEN PEOPLE UNABLE TO ATTEND THE STUDY SITE PARTICIPANTS OF OTHER PROGRAMS OF PHARMACEUTICAL CARE

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: PHARMACEUTICAL CARE<br> | Other: PHARMACEUTICAL CARE<br>* The pharmaceutical care program was characterized by face to face monthly visits to collect information, register information, prepare plan of care for every health problem; identification of drug therapy problems, communication to prescribers the drug therapy problems identified and education of participants to resolve the drug therapy problems.<br>|
| Other: HEALTH USUAL CARE<br> | Other: HEALTH USUAL CARE<br>* Usual care as defined in health consultations with doctors, nutritionists and nurses, access to laboratory tests and essential medicines<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GLYCATED HEMOGLOBIN (A1C) LEVELS | glycated hemoglobin levels was determined in the laboratory by high-performance liquid chromatography (HPLC) using venous blood as a sample | AT THE BEGINNING AND END OF STUDY (AFTER 6 MONTHS OF THE START) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FASTING GLUCOSE LEVELS | fasting glucose levels was determined in the laboratory by enzymatic colorimetric method using venous blood as a sample | AT THE BEGINNING AND END OF STUDY (AFTER 6 MONTHS OF THE START) | 
| TOTAL CHOLESTEROL LEVELS | total cholesterol levels was determined in the laboratory by enzymatic colorimetric method using venous blood as a sample | AT THE BEGINNING AND END OF STUDY (AFTER 6 MONTHS OF THE START) | 
| LDL CHOLESTEROL LEVELS | LDL levels was determined in the laboratory by enzymatic colorimetric method using venous blood as a sample | AT THE BEGINNING AND END OF STUDY (AFTER 6 MONTHS OF THE START) | 
| HDL CHOLESTEROL LEVELS | HDL levels was determined in the laboratory by enzymatic colorimetric method using venous blood as a sample | AT THE BEGINNING AND END OF STUDY (AFTER 6 MONTHS OF THE START) | 
| TRIGLYCERIDES LEVELS | triglycerides levels was determined in the laboratory by enzymatic colorimetric method using venous blood as a sample | AT THE BEGINNING AND END OF STUDY (AFTER 6 MONTHS OF THE START) | 
| SYSTOLIC BLOOD PRESSURE LEVELS | blood pressure levels was determined by indirect method with digital sphygmomanometer, Omron HEM 742 | AT THE BEGINNING AND END OF STUDY (AFTER 6 MONTHS OF THE START) | 
| DIASTOLIC BLOOD PRESSURE LEVELS | blood pressure levels was determined by indirect method with digital sphygmomanometer, Omron HEM 742 | AT THE BEGINNING AND END OF STUDY (AFTER 6 MONTHS OF THE START) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PHARMACEUTICAL SERVICES, DIABETES MELLITUS