ChagasCare
Impact of The Pharmaceutical Care on the Quality of Life of Patients With Chagas Disease and Heart Failure: Randomized Clinical Trial
Sponsor study identifier
Secondary identifiers
OTHER · Research Ethics Committee of the Evandro Chagas Clinical Research Institute (IPEC)
interventional
88
1 country
1
Study Start
October 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 23, 2012
Actual (reported)March 29, 2012
Actual (reported)October 2012
Date type not reportedThis date has not been verified as actual or estimated.
January 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
March 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
Incidence and types of drug-related problems
12 months
Physical functional capacity.
12 months
(1) group who will receive standard care
(2) group who will receive 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.
These patients will only receive standard care, with out follow-up by the pharmacist
Evandro Chagas Clinical Research Institute
Rio de Janeiro, Rio de Janeiro, 21040360, Brazil
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.
Gilberto M Silva, pharmaceutical
Evandro Chagas Clinical Research Institute
First Submitted
March 23, 2012
First Posted
March 29, 2012
Study Start
October 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2017
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This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
January 21, 2016
Record last verified: 2016-01
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Source: ClinicalTrials.gov.
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