Pharmaceutical Care in Type 2 Diabetes
This study has been completed.
Sponsor:
Universidade Federal de Ouro Preto
Information provided by:
Universidade Federal de Ouro Preto
ClinicalTrials.gov Identifier:
NCT01298726
First received: February 17, 2011
Last updated: NA
Last verified: January 2011
History: No changes posted
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Purpose
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.
| Condition | Intervention |
|---|---|
|
DIABETES MELLITUS, TYPE 2 |
Other: PHARMACEUTICAL CARE Other: HEALTH USUAL CARE |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | Pharmaceutical Care Program for Users of Brazilian Public Health Care System With Type 2 Diabetes Mellitus: Randomized Controlled Clinical Trial |
Resource links provided by NLM:
Further study details as provided by Universidade Federal de Ouro Preto:
Primary Outcome Measures:
- GLYCATED HEMOGLOBIN (A1C) LEVELS [ Time Frame: AT THE BEGINNING AND END OF STUDY (AFTER 6 MONTHS OF THE START) ] [ Designated as safety issue: No ]glycated hemoglobin levels was determined in the laboratory by high-performance liquid chromatography (HPLC) using venous blood as a sample
Secondary Outcome Measures:
- FASTING GLUCOSE LEVELS [ Time Frame: AT THE BEGINNING AND END OF STUDY (AFTER 6 MONTHS OF THE START) ] [ Designated as safety issue: No ]fasting glucose levels was determined in the laboratory by enzymatic colorimetric method using venous blood as a sample
- TOTAL CHOLESTEROL LEVELS [ Time Frame: AT THE BEGINNING AND END OF STUDY (AFTER 6 MONTHS OF THE START) ] [ Designated as safety issue: No ]total cholesterol levels was determined in the laboratory by enzymatic colorimetric method using venous blood as a sample
- LDL CHOLESTEROL LEVELS [ Time Frame: AT THE BEGINNING AND END OF STUDY (AFTER 6 MONTHS OF THE START) ] [ Designated as safety issue: No ]LDL levels was determined in the laboratory by enzymatic colorimetric method using venous blood as a sample
- HDL CHOLESTEROL LEVELS [ Time Frame: AT THE BEGINNING AND END OF STUDY (AFTER 6 MONTHS OF THE START) ] [ Designated as safety issue: No ]HDL levels was determined in the laboratory by enzymatic colorimetric method using venous blood as a sample
- TRIGLYCERIDES LEVELS [ Time Frame: AT THE BEGINNING AND END OF STUDY (AFTER 6 MONTHS OF THE START) ] [ Designated as safety issue: No ]triglycerides levels was determined in the laboratory by enzymatic colorimetric method using venous blood as a sample
- SYSTOLIC BLOOD PRESSURE LEVELS [ Time Frame: AT THE BEGINNING AND END OF STUDY (AFTER 6 MONTHS OF THE START) ] [ Designated as safety issue: No ]blood pressure levels was determined by indirect method with digital sphygmomanometer, Omron HEM 742
- DIASTOLIC BLOOD PRESSURE LEVELS [ Time Frame: AT THE BEGINNING AND END OF STUDY (AFTER 6 MONTHS OF THE START) ] [ Designated as safety issue: No ]blood pressure levels was determined by indirect method with digital sphygmomanometer, Omron HEM 742
| Enrollment: | 100 |
| Study Start Date: | January 2010 |
| Study Completion Date: | October 2010 |
| Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| PHARMACEUTICAL CARE |
Other: PHARMACEUTICAL CARE
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.
|
| HEALTH USUAL CARE |
Other: HEALTH USUAL CARE
Usual care as defined in health consultations with doctors, nutritionists and nurses, access to laboratory tests and essential medicines
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01298726
Locations
| Brazil | |
| Universidade Federal de Ouro Preto | |
| Ouro Preto, Minas Gerais, Brazil, 35400-000 | |
Sponsors and Collaborators
Universidade Federal de Ouro Preto
Investigators
| Study Chair: | LISIANE S EV, DR | Universidade Federal de Ouro Preto |
| Study Director: | ANDREA G GRABE, DR | Universidade Federal de Ouro Preto |
More Information
No publications provided
| Responsible Party: | LISIANE DA SILVEIRA EV, UNIVERSIDADE FEDERAL DE OURO PRETO |
| ClinicalTrials.gov Identifier: | NCT01298726 History of Changes |
| Other Study ID Numbers: | 0040.0.238.000-09 |
| Study First Received: | February 17, 2011 |
| Last Updated: | February 17, 2011 |
| Health Authority: | Brazil: National Committee of Ethics in Research |
Keywords provided by Universidade Federal de Ouro Preto:
|
PHARMACEUTICAL SERVICES DIABETES MELLITUS |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013