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Impact of Pharmaceutical Care in Diabetics Patients (IPCD)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01580904
First Posted: April 19, 2012
Last Update Posted: February 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Universidade Federal do Rio Grande do Norte
Information provided by (Responsible Party):
Patrícia Trindade Costa Paulo, Universidade Estadual da Paraiba
Results First Submitted: March 11, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: Single (Care Provider);   Primary Purpose: Treatment
Condition: Diabetes Mellitus Type 2
Intervention: Behavioral: Intervention: Pharmaceutical Care

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
From September 2009 to December 2011.Medical clinic

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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).

Reporting Groups
  Description
Intervention Group

Patients will be followed by the pharmacist.

Intervention: Pharmaceutical Care : Patients will be followed by the pharmacist by the Pharmaceutical Care Practice

Control Group Patients will not be followed by the pharmacist.

Participant Flow:   Overall Study
    Intervention Group   Control Group
STARTED   51   49 
COMPLETED   47   42 
NOT COMPLETED   4   7 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Intervention Group

Patients will be followed by the pharmacist.

Intervention: Pharmaceutical Care : Patients will be followed by the pharmacist by the Pharmaceutical Care Practice

Control Group Patients will not be followed by the pharmacist.
Total Total of all reporting groups

Baseline Measures
   Intervention Group   Control Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 47   42   89 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      37  78.7%      30  71.4%      67  75.3% 
>=65 years      10  21.3%      12  28.6%      22  24.7% 
Gender 
[Units: Participants]
Count of Participants
     
Female      27  57.4%      22  52.4%      49  55.1% 
Male      20  42.6%      20  47.6%      40  44.9% 
Region of Enrollment 
[Units: Participants]
     
Brazil   47   42   89 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Glycated Hemoglobin   [ Time Frame: Up to 24 weeks ]

2.  Primary:   Fasting Glycemia   [ Time Frame: Up to 24 weeks ]

3.  Secondary:   Total Cholesterol   [ Time Frame: Up to 24 weeks ]

4.  Secondary:   LDL Cholesterol   [ Time Frame: Up to 24 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Impacto da Atenção Farmacêutica em pacientes diabéticos (IPCD)
Organization: Universidade Estadual da Paraíba
phone: 558387010977
e-mail: patriciatrindad@yahoo.com.br


Publications:

Responsible Party: Patrícia Trindade Costa Paulo, Universidade Estadual da Paraiba
ClinicalTrials.gov Identifier: NCT01580904     History of Changes
Other Study ID Numbers: UEParaiba
First Submitted: April 11, 2012
First Posted: April 19, 2012
Results First Submitted: March 11, 2016
Results First Posted: February 10, 2017
Last Update Posted: February 10, 2017