Back to resultsEducation Program for Patients Receiving Oral Anticoagulation
Primary Purpose
Cardiovascular Disease, Venous Thromboses, Atrial Fibrillation
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Educational program
Sponsored by
About this trial
This is an interventional supportive care trial for Cardiovascular Disease focused on measuring quality of life, medical adherence, warfarin, Health education
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.
Sites / Locations
- Hospital Estadual de Ribeirão PretoRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Educational Program
usual care
Arm Description
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
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
change from baseline in oral anticoagulation treatment adherence at 2 months
Treatment adhrence will be measure by on specif scale
Full Information
NCT ID
NCT01339611
First Posted
April 13, 2011
Last Updated
June 17, 2011
Sponsor
University of Sao Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
1. Study Identification
Unique Protocol Identification Number
NCT01339611
Brief Title
Education Program for Patients Receiving Oral Anticoagulation
Study Type
Interventional
2. Study Status
Record Verification Date
March 2010
Overall Recruitment Status
Unknown status
Study Start Date
May 2011 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
December 2012 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
University of Sao Paulo
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Disease, Venous Thromboses, Atrial Fibrillation, Blood Coagulation Disorders, Inherited
Keywords
quality of life, medical adherence, warfarin, Health education
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Educational Program
Arm Type
Experimental
Arm Description
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
Arm Title
usual care
Arm Type
Other
Arm Description
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 Type
Behavioral
Intervention Name(s)
Educational program
Intervention Description
Individual orientation (slides) during hospitalization period and telephone follow-up after discharge
Primary Outcome Measure Information:
Title
Change from Baseline in health-related quality of life at 2 months
Description
the health-related quality of life will be measure by Duke Anticoagulation Satisfaction Scale
Time Frame
baseline (hospitalization time) and two months after discahrge
Secondary Outcome Measure Information:
Title
change from baseline in oral anticoagulation treatment adherence at 2 months
Description
Treatment adhrence will be measure by on specif scale
Time Frame
baseline (hospitalization time) and two months after discahrge
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Flávia M Pelegrino, MNS, PhD candidate
Phone
55-16-36023402
Email
flavia-martinelli@bol.com.br
First Name & Middle Initial & Last Name or Official Title & Degree
Inaiara A Scalçone, MNS, PhD candidate
Phone
55-16-36023402
Email
inaenf@yahoo.com.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Flávia M Pelegrino, MNS, PhD candidate
Organizational Affiliation
University of São Paulo at Ribeirão Preto College of Nursing
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Inaiara S.A. Corbi, MNS, PhD candidate
Organizational Affiliation
University of São Paulo at Ribeirão Preto College of Nursing
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rosana A.S. Dantas, PhD
Organizational Affiliation
University of São Paulo at Ribeirão Preto College of Nursing
Official's Role
Study Director
Facility Information:
Facility Name
Hospital Estadual de Ribeirão Preto
City
Ribeirão Preto
State/Province
São Paulo
ZIP/Postal Code
14090140
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Flavia M Pelegrino, RN
Phone
16 36023402
Email
flavia-martineli@bol.com.br
First Name & Middle Initial & Last Name & Degree
Inaiara S Corbi, RN
Phone
16 36023402
Email
inaenf@yahoo.com
First Name & Middle Initial & Last Name & Degree
Rosana S Dantas, PhD
12. IPD Sharing Statement
Learn more about this trial
Education Program for Patients Receiving Oral Anticoagulation
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