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

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.

Study Overview

• Status: Unknown
• Conditions: Chagas Heart Disease
• Intervention / Treatment: Other: Standard care; Other: Standard care and Pharmaceutical care

• Study Type: Interventional
• Enrollment (Anticipated): 88
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Rio de Janeiro, Brazil, 21040360
    • Recruiting
    • Evandro Chagas Clinical Research Institute
    • Contact: Gilberto M Sperandio da Silva, pharmaceutist; Phone Number: 552138659648; Email: gilbertomarcelo@gmail.com
    • Principal Investigator: Gilberto M Sperandio da Silva, pharmaceutist

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life.	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.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence and types of drug-related problems	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.	12 months
Physical functional capacity.	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.	12 months

Collaborators and Investigators

• Sponsor: Evandro Chagas Institute of Clinical Research
• 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
• Investigators: Principal Investigator: Gilberto M Silva, pharmaceutical, Evandro Chagas Clinical Research Institute

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Anticipated): January 1, 2017
• Study Completion (Anticipated): March 1, 2017

Study Registration Dates

• First Submitted: March 23, 2012
• First Submitted That Met QC Criteria: March 28, 2012
• First Posted (Estimate): March 29, 2012

Study Record Updates

• Last Update Posted (Estimate): January 21, 2016
• Last Update Submitted That Met QC Criteria: January 20, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases
• Other Study ID Numbers: Chagas2303; 0034.0.009.000-11 (Other Identifier: Research Ethics Committee of the Evandro Chagas Clinical Research Institute (IPEC))