Chagas Heart DiseaseChagasCareNCT01566617
Impact of the Pharmaceutical Care on the Quality of Life in Patients With Chagas Heart Disease
A study of Chagas Heart Disease, run by Evandro Chagas Institute of Clinical Research at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 76 years
- Conditions the study is for
- Chagas Heart Disease
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteBrazil
- Study dates
- Oct 2012to Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 76 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Evandro Chagas Clinical Research Institute
Rio de Janeiro, Rio de Janeiro, 21040360
Gilberto M Sperandio da Silva, pharmaceutist, 552138659648, gilbertomarcelo@gmail.com
Gilberto M Sperandio da Silva, pharmaceutist
About this study
Official title: Impact of The Pharmaceutical Care on the Quality of Life of Patients With Chagas Disease and Heart Failure: Randomized Clinical Trial
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.
- Conditions
- Chagas Heart Disease
- Being tested
- Standard care and Pharmaceutical care, Standard care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard care and Pharmaceutical careOther
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.
Standard careOther
These patients will only receive standard care, with out follow-up by the pharmacist
| Study group | Role | What they receive |
|---|---|---|
| Standard Care | Other | (1) group who will receive standard care Receives: Other: Standard care |
| Standard Care and Pharmaceutical Care | Other | (2) group who will receive standard care and pharmaceutical care Receives: Other: Standard care and Pharmaceutical care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (2)
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.
Measured: 12 months
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2012 (estimated)
- Study startOct 2012
- Primary completionJan 2017 (estimated)
- Study completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chagas Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Evandro Chagas Institute of Clinical Research
- Sponsor type
- University, hospital or other
- Collaborators
- Alejandro Marcel Hasslocher Moreno, MD MSc PhD student, Andrea Costa, MD PhD, Andrea Silvestre de Sousa, MD PhD, Luiz Henrique C. Sangenis, MD MSc PhD student, Marcelo Teixeira de Holanda, MD MSc PhD student, Mayara da Costa Chambela - MSc student, Pedro Emmanuel Alvarenga Americano do Brasil, MD PhD, Roberto Magalhães Saraiva, MD PhD, Sergio Salles Xavier, MD PhD
- Responsible party
- Principal investigator, Gilberto Marcelo Sperandio da Silva, Evandro Chagas Institute of Clinical Research
- Investigators
- Gilberto M Silva, pharmaceutical, Principal investigator, Evandro Chagas Clinical Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01566617
- Sponsor's protocol ID
- Chagas2303
- Other IDs
- 0034.0.009.000-11
- Acronym
- ChagasCare
- Status last verified
- Jan 2016
- First submitted
- 23 Mar 2012
- Last updated
- 21 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23270509
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of The Pharmaceutical Care on the Quality of Life of Patients With Chagas Disease and Heart Failure: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01566617
- Acronym / sponsor ID
- ChagasCare / Chagas2303
- Conditions
- Chagas Heart Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Evandro Chagas Institute of Clinical ResearchUniversity, hospital or other
- Collaborators
- Alejandro Marcel Hasslocher Moreno, MD MSc PhD student, Andrea Costa, MD PhD, Andrea Silvestre de Sousa, MD PhD, Luiz Henrique C. Sangenis, MD MSc PhD student, Marcelo Teixeira de Holanda, MD MSc PhD student, Mayara da Costa Chambela - MSc student, Pedro Emmanuel Alvarenga Americano do Brasil, MD PhD, Roberto Magalhães Saraiva, MD PhD, Sergio Salles Xavier, MD PhD
- Study start
- Oct 2012
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 29 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Care | Other | Other: Standard care(1) group who will receive standard care |
| Standard Care and Pharmaceutical Care | Other | Other: Standard care and Pharmaceutical care(2) group who will receive standard care and pharmaceutical care |
Who may qualify
- Ages
- 18 to 76 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard care and Pharmaceutical carePharmaceutical 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. | Other | Standard Care and Pharmaceutical Care |
| Standard careThese patients will only receive standard care, with out follow-up by the pharmacist | Other | Standard Care |
Primary outcome
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.
2 secondary outcomes
Incidence and types of drug-related problems
Time frame: 12 months
Physical functional capacity.
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2016.
- Derived from this study: PubMed 23270509Sperandio 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.
Related trials for Chagas Heart Disease
Recruiting
Cardiac Contractility Modulation in Chagas Heart Disease
Chagas Cardiomyopathy, Heart Failure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gilberto M Silva, pharmaceutical principal investigator
Evandro Chagas Clinical Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Chagas Heart Disease, run by Evandro Chagas Institute of Clinical Research at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mayara C Chambela, pharmaceutics (552138659648, Mayarachambela@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01566617, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2016.