Open Access Study protocol

Impact of pharmaceutical care on the quality of life of patients with Chagas disease and heart failure: randomized clinical trial

Gilberto M Sperandio da Silva*, Mayara C Chambela, Andrea S Sousa, Luiz Henrique C Sangenis, Sergio S Xavier, Andréa R Costa, Pedro Emmanuel AA Brasil, Alejandro M Hasslocher-Moreno and Roberto M Saraiva

Author Affiliations

Evandro Chagas Clinical Research Institute, Oswaldo Cruz Foundation, Av. Brasil 4365, Rio de Janeiro, RJ, 21040-900, Brazil

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Trials 2012, 13:244  doi:10.1186/1745-6215-13-244

Published: 27 December 2012

Abstract

Background

Pharmaceutical care is the direct interaction between pharmacist and patient, in order to improve therapeutic compliance, promote adequate pharmacotherapeutic follow-up, and improve quality of life. Pharmaceutical care may be effective in reducing complications and in improving the quality of life of patients with chronic diseases, like Chagas heart disease, while bringing a positive impact on health system costs. The morbidity and mortality indexes for patients with Chagas heart disease are high, especially if this heart disease is complicated by heart failure. In this setting, we hypothesize that pharmaceutical care might be an important tool for the clinical management of these patients by improving their quality of life, as a better compliance to their treatment and the avoidance and prompt correction of drug-related problems will minimize their symptoms, improve their functional class, and decrease the number of hospital admissions. 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.

Methods/design

A prospective, single-center randomized clinical trial will be conducted in patients with Chagas heart disease complicated by heart failure. A total of 88 patients will be randomly assigned into two parallel groups: an intervention group will receive standard care and pharmaceutical care, and a control group 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, exercise tolerance as measured by the standard six-minute-walk test, and compliance.

Discussion

Patients with Chagas heart disease complicated by heart failure under pharmaceutical care are expected to improve their quality of life, present with a lower incidence of drug-related problems, improve their functional capacity, and improve in their compliance to treatment.

Trial registration

ClinicalTrials.gov Identifier: NCT01566617

Keywords:
Chagas disease; Heart failure; Pharmaceutical care; Quality of life