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Clinical Trials/NCT01339611
NCT01339611
Unknown
Not Applicable

Education Program for Patients Receiving Oral Anticoagulation

University of Sao Paulo1 site in 1 country160 target enrollmentMay 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cardiovascular Disease
Sponsor
University of Sao Paulo
Enrollment
160
Locations
1
Primary Endpoint
Change from Baseline in health-related quality of life at 2 months
Last Updated
14 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 2011
End Date
December 2012
Last Updated
14 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • change from baseline in oral anticoagulation treatment adherence at 2 months(baseline (hospitalization time) and two months after discahrge)

Study Sites (1)

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