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Education Program for Patients Receiving Oral Anticoagulation

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01339611
Enrollment
160
Registered
2011-04-20
Start date
2011-05-31
Completion date
2012-12-31
Last updated
2011-06-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation, Blood Coagulation Disorders, Inherited, Cardiovascular Disease, Venous Thromboses

Keywords

quality of life, medical adherence, warfarin, Health education

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.

Interventions

BEHAVIORALEducational program

Individual orientation (slides) during hospitalization period and telephone follow-up after discharge

Sponsors

Fundação de Amparo à Pesquisa do Estado de São Paulo
CollaboratorOTHER_GOV
University of Sao Paulo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change from Baseline in health-related quality of life at 2 monthsbaseline (hospitalization time) and two months after discahrgethe health-related quality of life will be measure by Duke Anticoagulation Satisfaction Scale

Secondary

MeasureTime frameDescription
change from baseline in oral anticoagulation treatment adherence at 2 monthsbaseline (hospitalization time) and two months after discahrgeTreatment adhrence will be measure by on specif scale

Countries

Brazil

Contacts

Primary ContactFlávia M Pelegrino, MNS, PhD candidate
flavia-martinelli@bol.com.br55-16-36023402
Backup ContactInaiara A Scalçone, MNS, PhD candidate
inaenf@yahoo.com.br55-16-36023402

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026