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Education Program for Patients Receiving Oral Anticoagulation

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ClinicalTrials.gov Identifier: NCT01339611
Recruitment Status : Unknown
Verified March 2010 by University of Sao Paulo.
Recruitment status was:  Recruiting
First Posted : April 20, 2011
Last Update Posted : June 20, 2011
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief 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.

Condition or disease Intervention/treatment
Cardiovascular Disease Venous Thromboses Atrial Fibrillation Blood Coagulation Disorders, Inherited Behavioral: Educational program

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Study Start Date : May 2011
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Educational Program
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
Behavioral: Educational program
Individual orientation (slides) during hospitalization period and telephone follow-up after discharge
usual care
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.
Behavioral: Educational program
Individual orientation (slides) during hospitalization period and telephone follow-up after discharge


Outcome Measures

Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. change from baseline in oral anticoagulation treatment adherence at 2 months [ Time Frame: baseline (hospitalization time) and two months after discahrge ]
    Treatment adhrence will be measure by on specif scale


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01339611


Contacts
Contact: Flávia M Pelegrino, MNS, PhD candidate 55-16-36023402 flavia-martinelli@bol.com.br
Contact: Inaiara A Scalçone, MNS, PhD candidate 55-16-36023402 inaenf@yahoo.com.br

Locations
Brazil
Hospital Estadual de Ribeirão Preto Recruiting
Ribeirão Preto, São Paulo, Brazil, 14090140
Contact: Flavia M Pelegrino, RN    16 36023402    flavia-martineli@bol.com.br   
Contact: Inaiara S Corbi, RN    16 36023402    inaenf@yahoo.com   
Principal Investigator: Rosana S Dantas, PhD         
Sponsors and Collaborators
University of Sao Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
Principal Investigator: Flávia M Pelegrino, MNS, PhD candidate University of São Paulo at Ribeirão Preto College of Nursing
Principal Investigator: Inaiara S.A. Corbi, MNS, PhD candidate University of São Paulo at Ribeirão Preto College of Nursing
Study Director: Rosana A.S. Dantas, PhD University of São Paulo at Ribeirão Preto College of Nursing
More Information

Responsible Party: Rosana Aparecida Spadoti Dantas, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01339611     History of Changes
Other Study ID Numbers: OATeducation
First Posted: April 20, 2011    Key Record Dates
Last Update Posted: June 20, 2011
Last Verified: March 2010

Keywords provided by University of Sao Paulo:
quality of life
medical adherence
warfarin
Health education

Additional relevant MeSH terms:
Atrial Fibrillation
Cardiovascular Diseases
Thrombosis
Venous Thrombosis
Blood Coagulation Disorders
Hemostatic Disorders
Blood Coagulation Disorders, Inherited
Arrhythmias, Cardiac
Heart Diseases
Pathologic Processes
Embolism and Thrombosis
Vascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Genetic Diseases, Inborn