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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01339611
Other study ID # OATeducation
Secondary ID
Status Recruiting
Phase N/A
First received April 13, 2011
Last updated June 17, 2011
Start date May 2011
Est. completion date December 2012

Study information

Verified date March 2010
Source University of Sao Paulo
Contact Flávia M Pelegrino, MNS, PhD candidate
Phone 55-16-36023402
Email flavia-martinelli@bol.com.br
Is FDA regulated No
Health authority Brazil: National Committee of Ethics in Research
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 160
Est. completion date December 2012
Est. primary completion date December 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care


Intervention

Behavioral:
Educational program
Individual orientation (slides) during hospitalization period and telephone follow-up after discharge

Locations

Country Name City State
Brazil Hospital Estadual de Ribeirão Preto Ribeirão Preto São Paulo

Sponsors (2)

Lead Sponsor Collaborator
University of Sao Paulo Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Yes
Secondary 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 Yes
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