Education Program for Patients Receiving Oral Anticoagulation

Not Applicable

• Conditions: Cardiovascular Disease; Venous Thromboses; Atrial Fibrillation; Blood Coagulation Disorders, Inherited
• Interventions: Behavioral: Educational program

• Registration Number: NCT01339611
• Lead Sponsor: University of Sao Paulo

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.

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 Timeline

• Status Verified: 2010-03
• Study First Submitted: 2011-04-13
• Study First Submitted QC: 2011-04-19
• Study First Posted: 2011-04-20
• Study Start: 2011-05
• Last Update Submitted: 2011-06-17
• Last Update Posted: 2011-06-20
• Primary Completion: 2012-12
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 160

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Educational Program	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
usual care	Educational program	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.

Primary Outcome Measures

Name	Time	Method
Change from Baseline in health-related quality of life at 2 months	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

Name	Time	Method
change from baseline in oral anticoagulation treatment adherence at 2 months	baseline (hospitalization time) and two months after discahrge	Treatment adhrence will be measure by on specif scale

Trial Locations

Locations (1)

Hospital Estadual de Ribeirão Preto; 🇧🇷 Ribeirão Preto, São Paulo, Brazil