Impact of the Pharmaceutical Care on the Quality of Life in Patients With Chagas Heart Disease
ChagasCare
Impact of The Pharmaceutical Care on the Quality of Life of Patients With Chagas Disease and Heart Failure: Randomized Clinical Trial
2 other identifiers
interventional
88
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2012
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 23, 2012
CompletedFirst Posted
Study publicly available on registry
March 29, 2012
CompletedStudy Start
First participant enrolled
October 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2017
CompletedJanuary 21, 2016
January 1, 2016
4.3 years
March 23, 2012
January 20, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (2)
Incidence and types of drug-related problems
12 months
Physical functional capacity.
12 months
Study Arms (2)
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
Interventions
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.
These patients will only receive standard care, with out follow-up by the pharmacist
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Evandro Chagas Institute of Clinical Researchlead
- Alejandro Marcel Hasslocher Moreno, MD MSc PhD studentcollaborator
- Andrea Costa, MD PhDcollaborator
- Andrea Silvestre de Sousa, MD PhDcollaborator
- Luiz Henrique C. Sangenis, MD MSc PhD studentcollaborator
- Marcelo Teixeira de Holanda, MD MSc PhD studentcollaborator
- Mayara da Costa Chambela - MSc studentcollaborator
- Pedro Emmanuel Alvarenga Americano do Brasil, MD PhDcollaborator
- Roberto Magalhães Saraiva, MD PhDcollaborator
- Sergio Salles Xavier, MD PhDcollaborator
Study Sites (1)
Evandro Chagas Clinical Research Institute
Rio de Janeiro, Rio de Janeiro, 21040360, Brazil
Related Publications (1)
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.
PMID: 23270509DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gilberto M Silva, pharmaceutical
Evandro Chagas Clinical Research Institute
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD
Study Record Dates
First Submitted
March 23, 2012
First Posted
March 29, 2012
Study Start
October 1, 2012
Primary Completion
January 1, 2017
Study Completion
March 1, 2017
Last Updated
January 21, 2016
Record last verified: 2016-01