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

March 23, 2012
May 23, 2013
October 2012
August 2014   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01566617 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Impact of the Pharmaceutical Care on the Quality of Life in Patients With Chagas Heart Disease
Impact of The Pharmaceutical Care on the Quality of Life of Patients With Chagas Disease and Heart Failure: Randomized Clinical Trial

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Chagas Heart Disease
  • 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.
  • Other: Standard care
    These patients will only receive standard care, with out follow-up by the pharmacist
  • Standard Care
    (1) group who will receive standard care
    Intervention: Other: Standard care
  • Standard Care and Pharmaceutical Care
    (2) group who will receive standard care and pharmaceutical care
    Intervention: Other: Standard care and Pharmaceutical care
Sperandio da Silva GM, Chambela MC, Sousa AS, Sangenis LH, Xavier SS, Costa AR, Brasil PE, Hasslocher-Moreno AM, Saraiva RM. Impact of pharmaceutical care on the quality of life of patients with Chagas disease and heart failure: randomized clinical trial. Trials. 2012 Dec 27;13:244. doi: 10.1186/1745-6215-13-244.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
88
October 2014
August 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years to 76 Years
No
Contact: Mayara C Chambela, pharmaceutics 552138659648 Mayarachambela@gmail.com
Contact: Gilberto M Silva 552138659648 gilbertomarcelo@gmail.com
Brazil
 
NCT01566617
Chagas2303, 0034.0.009.000-11
No
Gilberto Marcelo Sperandio da Silva, Evandro Chagas Institute of Clinical Research
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
Principal Investigator: Gilberto M Silva, pharmaceutical Evandro Chagas Clinical Research Institute
Evandro Chagas Institute of Clinical Research
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP