Education Program for Patients Receiving Oral Anticoagulation

Study Overview
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Brief Summary
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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
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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
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Cardiovascular Disease, Venous Thromboses, Atrial Fibrillation, Blood Coagulation Disorders, Inherited

Intervention / Treatment
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* Behavioral: Educational program


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Educational Program<br>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<br>* Individual orientation (slides) during hospitalization period and telephone follow-up after discharge<br>|
| Other: usual care<br>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<br>* Individual orientation (slides) during hospitalization period and telephone follow-up after discharge<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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quality of life, medical adherence, warfarin, Health education