Cardiovascular DiseaseNCT01339611
Education Program for Patients Receiving Oral Anticoagulation
A study testing Educational program in people with Cardiovascular Disease and Venous Thromboses, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
The aim of the study is to test if patients under oral anticoagulation therapy who are going to participate in the education program will have better Health-related quality of life, higher rate in pharmacological treatment adherence and better self efficacy to manage the treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Disease, Venous Thromboses, Atrial Fibrillation
- What is being tested?
- Educational program
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteBrazil
- Study dates
- May 2011to Dec 2012
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients admitted in two public hospitals, in São Paulo state interior and who are going to start the use of oral anticoagulant during this hospitalization
- Patients admitted in two public hospitals, in São Paulo state interior and who are going to adjust therapeutically oral anticoagulant dosage or to start over treatment.
Who cannot join
- Individuals who do not at all have any ability to understand the data collection instrument questions, measured by the instrument Mental State Mini-exam.
- Individuals who do not have a telephone to be contacted after hospital discharge;
- Individuals who are going to metallic valve prosthesis implant surgery in the last six months.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Hospital Estadual de Ribeirão Preto
Ribeirão Preto, São Paulo, 14090140
Flavia M Pelegrino, RN, 16 36023402, flavia-martineli@bol.com.br
Inaiara S Corbi, RN, 16 36023402, inaenf@yahoo.com
About this study
The aim of the study is to test if patients under oral anticoagulation therapy who are going to participate in the education program will have better Health-related quality of life, higher rate in pharmacological treatment adherence and better self efficacy to manage the treatment.
Read the detailed description
Patients who are going to use oral anticoagulant will participate in an individual orientation, using instructional material (slides and illustrative booklet) during hospitalization period. After the discharge 2 phone calls will be done (after: a week and four weeks) focusing on the strategies to improve patient's self-efficacy to manage the oral anticoagulation. There will be a personal contact among researcher and participants when the patients return at the oral anticoagulant ambulatory, two months after the treatment start. At this time the following variables of interest will be evaluated: Health-related quality of life; adherence to treatment and patients' self-efficacy.
- Conditions
- Cardiovascular Disease, Venous Thromboses, Atrial Fibrillation, Blood Coagulation Disorders, Inherited
- Being tested
- Educational program
- Keywords
- quality of life, medical adherence, warfarin, Health education
- Medical subject headings
- Cardiovascular Diseases, Venous Thrombosis, Atrial Fibrillation, Blood Coagulation Disorders, Inherited, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational programBehavioural
Individual orientation (slides) during hospitalization period and telephone follow-up after discharge
| Study group | Role | What they receive |
|---|---|---|
| Educational Program | Experimental | Patients who are going to use of oral anticoagulant will participate in an individual orientation, using instructional material (slides and illustrative booklet) during hospitalization period and the telephone follow-up at a week and four weeks after discharge Receives: Behavioral: Educational program |
| usual care | Other | Patients who are going to use of oral anticoagulant will have usual orientation from the health service (illustrative booklet) during hospitalization time. No telephone follow-up after discharge. Receives: Behavioral: Educational program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in health-related quality of life at 2 months
the health-related quality of life will be measure by Duke Anticoagulation Satisfaction Scale
Measured: baseline (hospitalization time) and two months after discahrge
Secondary outcomes (1)
change from baseline in oral anticoagulation treatment adherence at 2 months
Treatment adhrence will be measure by on specif scale
Measured: baseline (hospitalization time) and two months after discahrge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2011 (estimated)
- Study startMay 2011
- Primary completionDec 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular 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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Investigators
- Flávia M Pelegrino, MNS, PhD candidate, Principal investigator, University of São Paulo at Ribeirão Preto College of NursingInaiara S.A. Corbi, MNS, PhD candidate, Principal investigator, University of São Paulo at Ribeirão Preto College of NursingRosana A.S. Dantas, PhD, Study director, University of São Paulo at Ribeirão Preto College of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01339611
- Sponsor's protocol ID
- OATeducation
- Status last verified
- Mar 2010
- First submitted
- 13 Apr 2011
- Last updated
- 20 Jun 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Education Program for Patients Receiving Oral Anticoagulation
- ClinicalTrials.gov ID
- NCT01339611
- Acronym / sponsor ID
- OATeducation
- Conditions
- Cardiovascular Disease, Venous Thromboses, Atrial Fibrillation, Blood Coagulation Disorders, Inherited
- Keywords
- quality of life, medical adherence, warfarin, Health education
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- May 2011
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 20 Apr 2011 (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 aim of the study is to test if patients under oral anticoagulation therapy who are going to participate in the education program will have better Health-related quality of life, higher rate in pharmacological treatment adherence and better self efficacy to manage the treatment.
Detailed description
Patients who are going to use oral anticoagulant will participate in an individual orientation, using instructional material (slides and illustrative booklet) during hospitalization period. After the discharge 2 phone calls will be done (after: a week and four weeks) focusing on the strategies to improve patient's self-efficacy to manage the oral anticoagulation. There will be a personal contact among researcher and participants when the patients return at the oral anticoagulant ambulatory, two months after the treatment start. At this time the following variables of interest will be evaluated: Health-related quality of life; adherence to treatment and patients' self-efficacy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Educational Program | Experimental | Behavioral: Educational programPatients who are going to use of oral anticoagulant will participate in an individual orientation, using instructional material (slides and illustrative booklet) during hospitalization period and the telephone follow-up at a week and four weeks after discharge |
| usual care | Other | Behavioral: Educational programPatients who are going to use of oral anticoagulant will have usual orientation from the health service (illustrative booklet) during hospitalization time. No telephone follow-up after discharge. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients admitted in two public hospitals, in São Paulo state interior and who are going to start the use of oral anticoagulant during this hospitalization
- Patients admitted in two public hospitals, in São Paulo state interior and who are going to adjust therapeutically oral anticoagulant dosage or to start over treatment.
Key exclusion criteria (3 listed)
- Individuals who do not at all have any ability to understand the data collection instrument questions, measured by the instrument Mental State Mini-exam.
- Individuals who do not have a telephone to be contacted after hospital discharge;
- Individuals who are going to metallic valve prosthesis implant surgery in the last six months.
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 |
|---|---|---|
| Educational programIndividual orientation (slides) during hospitalization period and telephone follow-up after discharge | Behavioural | Educational Program, usual care |
Primary outcome
Change from Baseline in health-related quality of life at 2 months
Time frame: baseline (hospitalization time) and two months after discahrge
the health-related quality of life will be measure by Duke Anticoagulation Satisfaction Scale
1 secondary outcome
change from baseline in oral anticoagulation treatment adherence at 2 months
Time frame: baseline (hospitalization time) and two months after discahrge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2011.
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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.
Flávia M Pelegrino, MNS, PhD candidate principal investigator
University of São Paulo at Ribeirão Preto College of Nursing
Inaiara S.A. Corbi, MNS, PhD candidate principal investigator
University of São Paulo at Ribeirão Preto College of Nursing
Rosana A.S. Dantas, PhD study director
University of São Paulo at Ribeirão Preto College of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational program in people with Cardiovascular Disease and Venous Thromboses, run by University of Sao Paulo 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 2 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 20 Jun 2011. 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 Flávia M Pelegrino, MNS, PhD candidate (55-16-36023402, flavia-martinelli@bol.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in health-related quality of life at 2 months (time frame: baseline (hospitalization time) and two months after discahrge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jun 2011.