NCT01566617

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 88 (estimated)
• Sponsor: Evandro Chagas Institute of Clinical Research · Academic / Other
• Sex: All
• Age: 18 Years – 76 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chagas Heart Disease

Interventions

Type	Name	Description
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

Timeline

• Start date: 2012-10-01
• Primary completion: 2017-01-01
• Completion: 2017-03-01
• First posted: 2012-03-29
• Last updated: 2016-01-21

Locations

1 site across 1 country: Brazil