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| Name | Class |
|---|---|
| Universidade Federal do Rio Grande do Norte | OTHER |
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The monitoring of diabetics by the pharmacist may contribute to the effectiveness of drug treatment and to improve their quality of life. This study will measure the impact of pharmacotherapeutic follow-up in diabetic patients. This will be a clinical trial, single blind, controlled, randomized, conducted in two units of pharmacies in Brazil. Only in the intervention group will be held the pharmacotherapeutic follow using a methodology called the practice of pharmaceutical care, which identifies and resolves problems related to drugs. The primary outcome is glycated hemoglobin, and secondary outcomes are baseline glucose, total cholesterol and its fractions (for example LDL), all these measures will be made in the intervention group and control group. Patients will be followed for 24 weeks, and the outcomes will be assessed up to 24 weeks. There will be a confidence interval of 95% and a significance of p <0.05, and will use the Student t test, chi-square analysis of variance (ANOVA) and others if necessary. Expects good results and serve as a model for other researchers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control group | No Intervention | Patients will not be followed by the pharmacist. | |
| Intervention group | Experimental | Patients will be followed by the pharmacist by Pharmacotherapeutic monitoring and dosing parameters such as glucose and glycated hemoglobin. Intervention: Pharmaceutical Care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intervention: Pharmaceutical Care | Behavioral | Patients will be followed by the pharmacist by the Pharmaceutical Care Practice |
|
| Measure | Description | Time Frame |
|---|---|---|
| Glycated Hemoglobin | average glycated hemoglobin over 24 weeks | Up to 24 weeks |
| Fasting Glycemia | average fasting glycemia over 24 weeks | Up to 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Total Cholesterol | average total cholesterol over 24 weeks | Up to 24 weeks |
| LDL Cholesterol | average LDL cholesterol over 24 weeks | Up to 24 weeks |
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Inclusion Criteria:Inclusion criteria:
Exclusion Criteria:
those who had infectious diseases during the research
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| Name | Affiliation | Role |
|---|---|---|
| Ivonete A. Doutorado | Universidade Federal do Rio Grande do Norte | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidade Estadual da Paraíba | João Pessoa | Paraíba | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21616627 | Background | Mitchell B, Armour C, Lee M, Song YJ, Stewart K, Peterson G, Hughes J, Smith L, Krass I. Diabetes Medication Assistance Service: the pharmacist's role in supporting patient self-management of type 2 diabetes (T2DM) in Australia. Patient Educ Couns. 2011 Jun;83(3):288-94. doi: 10.1016/j.pec.2011.04.027. Epub 2011 May 26. |
| Label | URL |
|---|---|
| A journal that has a lot of research on this topic | View source |
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The exclusion criteria were (i) to have an infectious disease during the study, (ii) to miss three consecutive appointments, (iii) to stop the use of the hypoglycemic drugs by order of the doctor, and (iv) to deny the acceptance of the term of free and informed consent (TFIC).
From September 2009 to December 2011.Medical clinic
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention Group | Patients will be followed by the pharmacist. Intervention: Pharmaceutical Care : Patients will be followed by the pharmacist by the Pharmaceutical Care Practice |
| FG001 | Control Group | Patients will not be followed by the pharmacist. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention Group | Patients will be followed by the pharmacist. Intervention: Pharmaceutical Care : Patients will be followed by the pharmacist by the Pharmaceutical Care Practice |
| BG001 | Control Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Glycated Hemoglobin | average glycated hemoglobin over 24 weeks | Data are glycated hemoglobin means of all patients per group. | Posted | Mean | Standard Deviation | percent (%) | Up to 24 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control Group | Patients will not be followed by the pharmacist. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stomach pain | Gastrointestinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Queasiness | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Impacto da Atenção Farmacêutica em pacientes diabéticos (IPCD) | Universidade Estadual da Paraíba | 558387010977 | patriciatrindad@yahoo.com.br |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| An interesting article on this topic | View source |
Patients will not be followed by the pharmacist.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Gender | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Primary | Fasting Glycemia | average fasting glycemia over 24 weeks | Posted | Mean | Standard Deviation | mg/dL | Up to 24 weeks |
|
|
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| Secondary | Total Cholesterol | average total cholesterol over 24 weeks | Posted | Mean | Standard Deviation | mg/dL | Up to 24 weeks |
|
|
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| Secondary | LDL Cholesterol | average LDL cholesterol over 24 weeks | Posted | Mean | Standard Deviation | mg/dL | Up to 24 weeks |
|
|
|
| 31 |
| 42 |
| 30 |
| 42 |
| EG001 | Intervention Group | Patients will be followed by the pharmacist. Intervention: Pharmaceutical Care: Patients will be followed by the pharmacist by the Pharmaceutical Care Practice | 34 | 47 | 32 | 47 |
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| D004700 | Endocrine System Diseases |