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

This study is not yet open for participant recruitment.

Verified April 2012 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: April 17, 2012

Last verified: April 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	March 23, 2012
Last Updated Date	April 17, 2012
Start Date ^ICMJE	October 2012
Estimated Primary Completion Date	August 2014 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: March 28, 2012)	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.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01566617 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: March 28, 2012)	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.
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 the Pharmaceutical Care on the Quality of Life in Patients With Chagas Heart Disease
Official Title ^ICMJE	Impact of The Pharmaceutical Care on the Quality of Life of Patients With Chagas Disease and Heart Failure: Randomized Clinical Trial
Brief Summary	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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver)
Condition ^ICMJE	Chagas Heart Disease
Intervention ^ICMJE	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
Study Arm (s)	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
Publications *	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.

Recruitment Information
Recruitment Status ^ICMJE	Not yet recruiting
Estimated Enrollment ^ICMJE	88
Estimated Completion Date	October 2014
Estimated Primary Completion Date	August 2014 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years to 76 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT01566617
Other Study ID Numbers ^ICMJE	Chagas2303, 0034.0.009.000-11
Has Data Monitoring Committee	No
Responsible Party	Gilberto Marcelo Sperandio da Silva, Evandro Chagas Institute of Clinical Research
Study Sponsor ^ICMJE	Evandro Chagas Institute of Clinical Research
Collaborators ^ICMJE	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 ^ICMJE	Not Provided
Information Provided By	Evandro Chagas Institute of Clinical Research
Verification Date	April 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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