Clinical trial NCT01339611: Education Program for Patients Receiving Oral Anticoagulation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cardiovascular Disease
Venous Thromboses
Atrial Fibrillation
Blood Coagulation Disorders, Inherited
Keywords: quality of life
medical adherence
warfarin
Health education
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2011-04-20
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Change from Baseline in health-related quality of life at 2 months
timeFrame: baseline (hospitalization time) and two months after discahrge
Secondary outcomes:
measure: change from baseline in oral anticoagulation treatment adherence at 2 months
timeFrame: baseline (hospitalization time) and two months after discahrge
Other outcomes:
Locations:
city: Ribeirão Preto
country: Brazil
facility: Hospital Estadual de Ribeirão Preto
state: São Paulo
Study officials:
affiliation: University of São Paulo at Ribeirão Preto College of Nursing
name: Flávia M Pelegrino, MNS, PhD candidate
role: PRINCIPAL_INVESTIGATOR
affiliation: University of São Paulo at Ribeirão Preto College of Nursing
name: Inaiara S.A. Corbi, MNS, PhD candidate
role: PRINCIPAL_INVESTIGATOR
affiliation: University of São Paulo at Ribeirão Preto College of Nursing
name: Rosana A.S. Dantas, PhD
role: STUDY_DIRECTOR
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