Impact of Pharmaceutical Care in Diabetics Patients (IPCD)
| Tracking Information | |||||
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| First Received Date ICMJE | April 11, 2012 | ||||
| Last Updated Date | April 17, 2012 | ||||
| Start Date ICMJE | September 2009 | ||||
| Primary Completion Date | December 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
glycated hemoglobin [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01580904 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Impact of Pharmaceutical Care in Diabetics Patients | ||||
| Official Title ICMJE | Popular Pharmacy of Brazil: Impact of Pharmaceutical Care in Diabetics Patients | ||||
| Brief Summary | 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 LDL, HDL and VLDL, 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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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Single Blind (Caregiver) Primary Purpose: Treatment |
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| Condition ICMJE | Diabetes Mellitus Type 2 | ||||
| Intervention ICMJE | Behavioral: Intervention: Pharmaceutical Care
Patients will be followed by the pharmacist by the Pharmaceutical Care Practice |
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| Study Arm (s) |
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| Publications * | 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. Epub 2011 May 26. | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 101 | ||||
| Completion Date | December 2011 | ||||
| Primary Completion Date | December 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:Inclusion criteria:
Exclusion Criteria: those who had infectious diseases during the research
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| Gender | Both | ||||
| Ages | 30 Years to 80 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Brazil | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01580904 | ||||
| Other Study ID Numbers ICMJE | UEParaiba | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Patrícia Trindade Costa Paulo, Universidade Estadual da Paraiba | ||||
| Study Sponsor ICMJE | Universidade Estadual da Paraiba | ||||
| Collaborators ICMJE | Universidade Federal do Rio Grande do Norte | ||||
| Investigators ICMJE |
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| Information Provided By | Universidade Estadual da Paraiba | ||||
| Verification Date | April 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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