Impact of the Pharmaceutical Care on the Quality of Life in Patients With Chagas Heart Disease (ChagasCare)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Evandro Chagas Institute of Clinical Research
Sponsor:
Collaborators:
Alejandro Marcel Hasslocher Moreno, MD MSc PhD student
Andrea Costa, MD PhD
Andrea Silvestre de Sousa, MD PhD
Luiz Henrique C. Sangenis, MD MSc PhD student
Marcelo Teixeira de Holanda, MD MSc PhD student
Mayara da Costa Chambela - MSc student
Pedro Emmanuel Alvarenga Americano do Brasil, MD PhD
Roberto Magalhães Saraiva, MD PhD
Sergio Salles Xavier, MD PhD
Information provided by (Responsible Party):
Gilberto Marcelo Sperandio da Silva, Evandro Chagas Institute of Clinical Research
ClinicalTrials.gov Identifier:
NCT01566617
First received: March 23, 2012
Last updated: May 23, 2013
Last verified: May 2013
  Purpose

The investigators hypothesize that pharmaceutical care may constitute an important tool for the clinical management of these patients by improving their compliance to their treatment with consequent improvement in their quality of life by minimizing symptoms, and decreasing the number of hospital admissions and adverse drug reactions. Therefore, the aim of this trial is to evaluate the contribution of pharmaceutical care to clinical treatment of patients with Chagas heart disease complicated by heart failure.

Study Type: Interventional

Study Design: A total of 88 patients will be randomly assigned into two parallel groups: (1) group who will receive standard care and pharmaceutical care; and (2) group who will receive only standard care. Both groups will be subjected to a follow-up period of 12 months. The primary outcome of this trial is the evaluation of quality of life, measured by the 36-item short-form and the Minnesota Living with Heart Failure Questionnaire. Secondary outcomes include drug-related problems and exercise tolerance measured by the standard six-minute walk test.


Condition Intervention
Chagas Heart Disease
Other: Standard care and Pharmaceutical care
Other: Standard care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Official Title: Impact of The Pharmaceutical Care on the Quality of Life of Patients With Chagas Disease and Heart Failure: Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by Evandro Chagas Institute of Clinical Research:

Primary Outcome Measures:
  • Quality of life. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    The primary outcome of this trial is the evaluation of quality of life, measured by the 36-item short-form and the Minnesota Living with Heart Failure Questionnaire. Evaluation of patient quality of life during follow up of two parallel groups: (1) group who will receive standard care and pharmaceutical care; and (2) group who will receive only standard care.


Secondary Outcome Measures:
  • Incidence and types of drug-related problems [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    To evaluate the drug-related problems based on the classification of the Brazilian Pharmaceutical Care Consensus. Evaluation of drug-related problems during follow up of two parallel groups: (1) group who will receive standard care and pharmaceutical care; and (2) group who will receive only standard care.

  • Physical functional capacity. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    All patients will have their physical functional capacity measured by the 6 minute-walk test (The patients will split in two parallel groups: (1) group who will receive standard care and pharmaceutical care; and (2) group who will receive only standard care). The test will be performed at the beginning of protocol and after 12 months of follow-up.


Estimated Enrollment: 88
Study Start Date: October 2012
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Standard Care
(1) group who will receive standard care
Other: Standard care
These patients will only receive standard care, with out follow-up by the pharmacist
Standard Care and Pharmaceutical Care
(2) group who will receive standard care and pharmaceutical care
Other: Standard care and Pharmaceutical care
Pharmaceutical care is the direct interaction between the pharmacist and the drug's users in order to improve the therapeutic compliance among outpatients and promote adequate pharmacotherapeutic follow-up.

  Eligibility

Ages Eligible for Study:   18 Years to 76 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The proposed clinical trial will be conducted in volunteers with Chagas disease complicated by heart failure.
  • Subjects will include adults, men and women, racial or ethnic minorities.
  • Diagnosed by two distinct Chagas serology tests (indirect immunofluorescence and enzyme linked immunosorbent assay

Exclusion Criteria:

  • Patients with any of comorbidities that significantly affect the cardiac performance, such as coronary artery disease, moderate or severe heart valvular disease, left ventricular (LV) hypertrophy, congenital heart disease, or that limit their survival, such as malignant tumors and HIV, will be excluded from the study.
  • Patients will be also be excluded in case of failure to give informed consent, inability to perform 6 minute- walk test, significant cognitive impairment, or pregnancy.
  • Individuals who are participating in others intervention trials will also be excluded.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01566617

Contacts
Contact: Mayara C Chambela, pharmaceutics 552138659648 Mayarachambela@gmail.com
Contact: Gilberto M Silva 552138659648 gilbertomarcelo@gmail.com

Locations
Brazil
Evandro Chagas Clinical Research Institute Recruiting
Rio de Janeiro, Brazil, 21040360
Contact: Gilberto M Sperandio da Silva, pharmaceutist    552138659648    gilbertomarcelo@gmail.com   
Principal Investigator: Gilberto M Sperandio da Silva, pharmaceutist         
Sponsors and Collaborators
Evandro Chagas Institute of Clinical Research
Alejandro Marcel Hasslocher Moreno, MD MSc PhD student
Andrea Costa, MD PhD
Andrea Silvestre de Sousa, MD PhD
Luiz Henrique C. Sangenis, MD MSc PhD student
Marcelo Teixeira de Holanda, MD MSc PhD student
Mayara da Costa Chambela - MSc student
Pedro Emmanuel Alvarenga Americano do Brasil, MD PhD
Roberto Magalhães Saraiva, MD PhD
Sergio Salles Xavier, MD PhD
Investigators
Principal Investigator: Gilberto M Silva, pharmaceutical Evandro Chagas Clinical Research Institute
  More Information

No publications provided by Evandro Chagas Institute of Clinical Research

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gilberto Marcelo Sperandio da Silva, PhD, Evandro Chagas Institute of Clinical Research
ClinicalTrials.gov Identifier: NCT01566617     History of Changes
Other Study ID Numbers: Chagas2303, 0034.0.009.000-11
Study First Received: March 23, 2012
Last Updated: May 23, 2013
Health Authority: Brazil: National Committee of Ethics in Research

Additional relevant MeSH terms:
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 20, 2014