Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 0034.0.009.000-11 | Other Identifier | Research Ethics Committee of the Evandro Chagas Clinical Research Institute (IPEC) |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Alejandro Marcel Hasslocher Moreno, MD MSc PhD student | UNKNOWN |
| Andrea Costa, MD PhD | UNKNOWN |
| Andrea Silvestre de Sousa, MD PhD | UNKNOWN |
| Luiz Henrique C. Sangenis, MD MSc PhD student |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Care | Other | (1) group who will receive standard care |
|
| Standard Care and Pharmaceutical Care | Other | (2) group who will receive standard care and pharmaceutical care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard care and Pharmaceutical care | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life. | 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. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and types of drug-related problems | 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. | 12 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mayara C Chambela, pharmaceutics | Contact | 552138659648 | Mayarachambela@gmail.com | |
| Gilberto M Silva | Contact | 552138659648 | gilbertomarcelo@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Gilberto M Silva, pharmaceutical | Evandro Chagas Clinical Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Evandro Chagas Clinical Research Institute | Recruiting | Rio de Janeiro | Rio de Janeiro | 21040360 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23270509 | Derived | Sperandio da Silva GM, Chambela MC, Sousa AS, Sangenis LH, Xavier SS, Costa AR, Brasil PE, Hasslocher-Moreno AM, Saraiva RM. Impact of pharmaceutical care on the quality of life of patients with Chagas disease and heart failure: randomized clinical trial. Trials. 2012 Dec 27;13:244. doi: 10.1186/1745-6215-13-244. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D059039 | Standard of Care |
| D010593 | Pharmaceutical Services |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
Not provided
Not provided
| UNKNOWN |
| Marcelo Teixeira de Holanda, MD MSc PhD student | UNKNOWN |
| Mayara da Costa Chambela - MSc student | UNKNOWN |
| Pedro Emmanuel Alvarenga Americano do Brasil, MD PhD | UNKNOWN |
| Roberto Magalhães Saraiva, MD PhD | UNKNOWN |
| Sergio Salles Xavier, MD PhD | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
Not provided
| Standard care | Other | These patients will only receive standard care, with out follow-up by the pharmacist |
|
| Physical functional capacity. | 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. | 12 months |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |