Education Program for Patients Receiving Oral Anticoagulation

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by University of Sao Paulo.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by:
University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01339611
First received: April 13, 2011
Last updated: June 17, 2011
Last verified: March 2010

April 13, 2011
June 17, 2011
May 2011
December 2012   (final data collection date for primary outcome measure)
Change from Baseline in health-related quality of life at 2 months [ Time Frame: baseline (hospitalization time) and two months after discahrge ] [ Designated as safety issue: Yes ]
the health-related quality of life will be measure by Duke Anticoagulation Satisfaction Scale
Same as current
Complete list of historical versions of study NCT01339611 on ClinicalTrials.gov Archive Site
change from baseline in oral anticoagulation treatment adherence at 2 months [ Time Frame: baseline (hospitalization time) and two months after discahrge ] [ Designated as safety issue: Yes ]
Treatment adhrence will be measure by on specif scale
Same as current
Not Provided
Not Provided
 
Education Program for Patients Receiving Oral Anticoagulation
Not Provided

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
  • Cardiovascular Disease
  • Venous Thromboses
  • Atrial Fibrillation
  • Blood Coagulation Disorders, Inherited
Behavioral: Educational program
Individual orientation (slides) during hospitalization period and telephone follow-up after discharge
  • 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
    Intervention: Behavioral: Educational program
  • 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.
    Intervention: Behavioral: Educational program
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
160
December 2012
December 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Flávia M Pelegrino, MNS, PhD candidate 55-16-36023402 flavia-martinelli@bol.com.br
Contact: Inaiara A Scalçone, MNS, PhD candidate 55-16-36023402 inaenf@yahoo.com.br
Brazil
 
NCT01339611
OATeducation
Not Provided
Rosana Aparecida Spadoti Dantas, University of Sao Paulo
University of Sao Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
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
University of Sao Paulo
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP