Education Program for Patients Receiving Oral Anticoagulation

NCT ID: NCT01339611

Last Updated: 2011-06-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2012-12-31

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Educational program

Intervention Type BEHAVIORAL

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.

Group Type OTHER

Educational program

Intervention Type BEHAVIORAL

Individual orientation (slides) during hospitalization period and telephone follow-up after discharge

Interventions

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Educational program

Individual orientation (slides) during hospitalization period and telephone follow-up after discharge

Intervention Type BEHAVIORAL

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role collaborator

University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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University of Sao Paulo

Principal Investigators

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Flávia M Pelegrino, MNS, PhD candidate

Role: PRINCIPAL_INVESTIGATOR

University of São Paulo at Ribeirão Preto College of Nursing

Inaiara S.A. Corbi, MNS, PhD candidate

Role: PRINCIPAL_INVESTIGATOR

University of São Paulo at Ribeirão Preto College of Nursing

Rosana A.S. Dantas, PhD

Role: STUDY_DIRECTOR

University of São Paulo at Ribeirão Preto College of Nursing

Locations

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Hospital Estadual de Ribeirão Preto

Ribeirão Preto, São Paulo, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Flávia M Pelegrino, MNS, PhD candidate

Role: CONTACT

55-16-36023402

Inaiara A Scalçone, MNS, PhD candidate

Role: CONTACT

55-16-36023402

Facility Contacts

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Flavia M Pelegrino, RN

Role: primary

16 36023402

Inaiara S Corbi, RN

Role: backup

16 36023402

Other Identifiers

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OATeducation

Identifier Type: -

Identifier Source: org_study_id

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