Impact of the Pharmaceutical Care on the Quality of Life in Patients With Chagas Heart Disease
- Conditions
- Chagas Heart Disease
- Interventions
- Other: Standard care and Pharmaceutical careOther: Standard care
- Registration Number
- NCT01566617
- Lead Sponsor
- Evandro Chagas Institute of Clinical Research
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 88
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard Care and Pharmaceutical Care Standard care and Pharmaceutical care (2) group who will receive standard care and pharmaceutical care Standard Care Standard care (1) group who will receive standard care
- Primary Outcome Measures
Name Time Method Quality of life. 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 Outcome Measures
Name Time Method Incidence and types of drug-related problems 12 months 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.
Physical functional capacity. 12 months 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.
Trial Locations
- Locations (1)
Evandro Chagas Clinical Research Institute
🇧🇷Rio de Janeiro, Brazil