Education Program for Patients Receiving Oral Anticoagulation

Sponsor

University of Sao Paulo (Other)

Overall Status

Unknown status

CT.gov ID

NCT01339611

Collaborator

Fundação de Amparo à Pesquisa do Estado de São Paulo (Other)

160

Enrollment

Location

Arms

19.1

Duration (Months)

8.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Disease Venous Thromboses Atrial Fibrillation Blood Coagulation Disorders, Inherited	Behavioral: Educational program	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

160 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Study Start Date :

May 1, 2011

Anticipated Primary Completion Date :

Dec 1, 2012

Anticipated Study Completion Date :

Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
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	Behavioral: Educational program Individual orientation (slides) during hospitalization period and telephone follow-up after discharge
Other: 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.	Behavioral: Educational program Individual orientation (slides) during hospitalization period and telephone follow-up after discharge

Arm

Intervention/Treatment

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

Behavioral: Educational program

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

Other: 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.

Behavioral: Educational program

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

Outcome Measures

Primary Outcome Measures

Change from Baseline in health-related quality of life at 2 months [baseline (hospitalization time) and two months after discahrge]
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 [baseline (hospitalization time) and two months after discahrge]
Treatment adhrence will be measure by on specif scale

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Estadual de Ribeirão Preto	Ribeirão Preto	São Paulo	Brazil	14090140

Sponsors and Collaborators

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

Investigators

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