Education Program for Patients Receiving Oral Anticoagulation
Recruitment status was Recruiting
| Tracking Information | |||||||||||||
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| First Received Date ICMJE | April 13, 2011 | ||||||||||||
| Last Updated Date | June 17, 2011 | ||||||||||||
| Start Date ICMJE | May 2011 | ||||||||||||
| Estimated Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||||||||||
| Current Primary Outcome Measures ICMJE |
Change from Baseline in health-related quality of life at 2 months [ Time Frame: baseline (hospitalization time) and two months after discahrge ] [ Designated as safety issue: Yes ] the health-related quality of life will be measure by Duke Anticoagulation Satisfaction Scale |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||
| Change History | Complete list of historical versions of study NCT01339611 on ClinicalTrials.gov Archive Site | ||||||||||||
| Current Secondary Outcome Measures ICMJE |
change from baseline in oral anticoagulation treatment adherence at 2 months [ Time Frame: baseline (hospitalization time) and two months after discahrge ] [ Designated as safety issue: Yes ] Treatment adhrence will be measure by on specif scale |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||||||
| Descriptive Information | |||||||||||||
| Brief Title ICMJE | Education Program for Patients Receiving Oral Anticoagulation | ||||||||||||
| Official Title ICMJE | Not Provided | ||||||||||||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||||||||||
| Study Phase | Not Provided | ||||||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care |
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| Condition ICMJE |
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| Intervention ICMJE | Behavioral: Educational program
Individual orientation (slides) during hospitalization period and telephone follow-up after discharge |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||||||
| Estimated Enrollment ICMJE | 160 | ||||||||||||
| Estimated Completion Date | December 2012 | ||||||||||||
| Estimated Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||||||
| Ages | 18 Years and older | ||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Brazil | ||||||||||||
| Administrative Information | |||||||||||||
| NCT Number ICMJE | NCT01339611 | ||||||||||||
| Other Study ID Numbers ICMJE | OATeducation | ||||||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||||||
| Responsible Party | Rosana Aparecida Spadoti Dantas, University of Sao Paulo | ||||||||||||
| Study Sponsor ICMJE | University of Sao Paulo | ||||||||||||
| Collaborators ICMJE | Fundação de Amparo à Pesquisa do Estado de São Paulo | ||||||||||||
| Investigators ICMJE |
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| Information Provided By | University of Sao Paulo | ||||||||||||
| Verification Date | March 2010 | ||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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