Education Program for Patients Receiving Oral Anticoagulation

Atrial Fibrillation Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01339611
• Other study ID #: OATeducation
• Status: Recruiting
• Phase: N/A
• First received: April 13, 2011
• Last updated: June 17, 2011
• Start date: May 2011
• Est. completion date: December 2012

Study information

• Verified date: March 2010
• Source: University of Sao Paulo
• Contact: Flávia M Pelegrino, MNS, PhD candidate
• Phone: 55-16-36023402
• Email: flavia-martinelli[@]bol.com.br
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Atrial Fibrillation
• Blood Coagulation Disorders
• Blood Coagulation Disorders, Inherited
• Cardiovascular Disease
• Cardiovascular Diseases
• Hemostatic Disorders
• Venous Thromboses
• Venous Thrombosis

Intervention

Behavioral:
• Educational program
Individual orientation (slides) during hospitalization period and telephone follow-up after discharge

Locations

Country	Name	City	State
Brazil	Hospital Estadual de Ribeirão Preto	Ribeirão Preto	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	baseline (hospitalization time) and two months after discahrge	Yes
Secondary	change from baseline in oral anticoagulation treatment adherence at 2 months	Treatment adhrence will be measure by on specif scale	baseline (hospitalization time) and two months after discahrge	Yes