Education Program for Patients Receiving Oral Anticoagulation

June 17, 2011 updated by: University of Sao Paulo
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.

Study Overview

Status

Unknown

Conditions

Intervention / 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 Type

Interventional

Enrollment (Anticipated)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • São Paulo
      • Ribeirão Preto, São Paulo, Brazil, 14090140
        • Recruiting
        • Hospital Estadual de Ribeirão Preto
        • Contact:
        • Contact:
        • Principal Investigator:
          • Rosana S Dantas, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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
OTHER: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
Time Frame: baseline (hospitalization time) and two months after discahrge
Treatment adhrence will be measure by on specif scale
baseline (hospitalization time) and two months after discahrge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (ANTICIPATED)

December 1, 2012

Study Completion (ANTICIPATED)

December 1, 2012

Study Registration Dates

First Submitted

April 13, 2011

First Submitted That Met QC Criteria

April 19, 2011

First Posted (ESTIMATE)

April 20, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

June 20, 2011

Last Update Submitted That Met QC Criteria

June 17, 2011

Last Verified

March 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OATeducation

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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