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

Abstract

BackgroundPharmaceutical 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/designA 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.DiscussionPatients 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 registrationClinicalTrials.gov Identifier: NCT01566617

The role of the pharmacist in the care of patients with cardiovascular diseases

“…One of the few randomised clinical trials in the area of social pharmacy carried out among patients with Chagas' disease complicated by HF showed a significant improvement of life of patients under pharmaceutical care as a result of reducing the number of drug problems and improved adherence [15]. Similar conclusions can be drawn from another study, which included patients with type 2 diabetes [16].…”

Health-Related Quality of Life and Functional Status Are Associated with Cardiac Status and Clinical Outcome in Children with Cardiomyopathy

“…Indeed, there are now pharmaceutical trials in patients with heart failure where quality of life is the primary, rather than secondary, outcome. 24 Our findings are important from a clinical perspective in that they suggest that children at greatest risk of clinical decline can be identified by these measures and warrant increased monitoring; and that formal functional status measurement should be integrated into prognostic assessment, similar to such increasing practice in adult care. 25 Uzark et al 26 demonstrated the clinical utility of such assessment in the setting of a pediatric cardiology clinic.…”

Developments in the management of Chagas cardiomyopathy

“…[133] Multidisciplinary approach of heart failure patients, including cardiac rehabilitation and pharmaceutical care, may be helpful in improving symptoms and quality of life in Chagas disease patients. [134,135]…”