NCT01339611

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2011

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 13, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 20, 2011

Completed
11 days until next milestone

Study Start

First participant enrolled

May 1, 2011

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

June 20, 2011

Status Verified

March 1, 2010

Enrollment Period

1.6 years

First QC Date

April 13, 2011

Last Update Submit

June 17, 2011

Conditions

Cardiovascular DiseaseVenous ThrombosesAtrial FibrillationBlood Coagulation Disorders, Inherited

Keywords

quality of lifemedical adherencewarfarinHealth education

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • change from baseline in oral anticoagulation treatment adherence at 2 months

    baseline (hospitalization time) and two months after discahrge

Study Arms (2)

Educational Program

EXPERIMENTAL

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

Behavioral: Educational program

usual care

OTHER

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.

Behavioral: Educational program

Interventions

Educational programBEHAVIORAL

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

Educational Programusual care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Estadual de Ribeirão Preto

Ribeirão Preto, São Paulo, 14090140, Brazil

RECRUITING

MeSH Terms

Conditions

Cardiovascular DiseasesVenous ThrombosisAtrial FibrillationBlood Coagulation Disorders, InheritedHealth Education

Condition Hierarchy (Ancestors)

ThrombosisEmbolism and ThrombosisVascular DiseasesArrhythmias, CardiacHeart DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesAdherence InterventionsMedication AdherencePatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

  • Rosana A.S. Dantas, PhD

    University of São Paulo at Ribeirão Preto College of Nursing

    STUDY DIRECTOR

Central Study Contacts

Flávia M Pelegrino, MNS, PhD candidate

CONTACT

55-16-36023402flavia-martinelli@bol.com.br

Inaiara A Scalçone, MNS, PhD candidate

CONTACT

55-16-36023402inaenf@yahoo.com.br

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 13, 2011

First Posted

April 20, 2011

Study Start

May 1, 2011

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

June 20, 2011

Record last verified: 2010-03

Locations

BR(1)