Pharmaceutical Care Program for Users of Brazilian Public Health Care System With Type 2 Diabetes Mellitus: Randomized Controlled Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 100
- Locations
- 2
- Primary Endpoint
- GLYCATED HEMOGLOBIN (A1C) LEVELS
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
GLYCATED HEMOGLOBIN (A1C) LEVELS
Time Frame: AT THE BEGINNING AND END OF STUDY (AFTER 6 MONTHS OF THE START)
glycated hemoglobin levels was determined in the laboratory by high-performance liquid chromatography (HPLC) using venous blood as a sample
Secondary Outcomes
- FASTING GLUCOSE LEVELS(AT THE BEGINNING AND END OF STUDY (AFTER 6 MONTHS OF THE START))
- TOTAL CHOLESTEROL LEVELS(AT THE BEGINNING AND END OF STUDY (AFTER 6 MONTHS OF THE START))
- LDL CHOLESTEROL LEVELS(AT THE BEGINNING AND END OF STUDY (AFTER 6 MONTHS OF THE START))
- HDL CHOLESTEROL LEVELS(AT THE BEGINNING AND END OF STUDY (AFTER 6 MONTHS OF THE START))
- SYSTOLIC BLOOD PRESSURE LEVELS(AT THE BEGINNING AND END OF STUDY (AFTER 6 MONTHS OF THE START))
- TRIGLYCERIDES LEVELS(AT THE BEGINNING AND END OF STUDY (AFTER 6 MONTHS OF THE START))
- DIASTOLIC BLOOD PRESSURE LEVELS(AT THE BEGINNING AND END OF STUDY (AFTER 6 MONTHS OF THE START))