Impact of The Pharmaceutical Care on the Quality of Life of Patients With Chagas Disease and Heart Failure: Randomized Clinical Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chagas Heart Disease
- Sponsor
- Evandro Chagas Institute of Clinical Research
- Enrollment
- 88
- Locations
- 1
- Primary Endpoint
- Quality of life.
- Last Updated
- 10 years ago
Overview
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.
Investigators
Gilberto Marcelo Sperandio da Silva
PhD
Evandro Chagas Institute of Clinical Research
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Quality of life.
Time Frame: 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. 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.
Secondary Outcomes
- Incidence and types of drug-related problems(12 months)
- Physical functional capacity.(12 months)