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SALTO - Epidemiological Study on Compliance and Treatment Satisfaction

NCT ID: NCT00911001

Last Updated: 2013-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

480 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-11-30

Study Completion Date

2009-03-31

Brief Summary

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Patients that are on total knee/hip replacement initiate prophylaxis treatment on the hospital ground. Once they leave the hospital, as outpatients they continue with the treatment at least during two consecutive weeks. Patients will be instructed to follow treatment recommendations (either LMWH or oral treatment, at physician discretion) and to come back to the surgeon after that period. At that visit, the Treatment Satisfaction Questionaire with Medication (TSQM) test as well as the Moriski-Green Questionaire (measures compliance with medication) will be answer by the patient. TSQM is an self administered validated scale (validated also in spanish) that measures in a generic way the treatment satisfaction to a treatment. Morinski-Green test will be used to measure the compliance degree on medication.

Detailed Description

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Conditions

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Thromboembolism

Keywords

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Arthroplasty Antithrombotic prophylaxis treatment Replacement Knee

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

No Drug

Intervention Type BEHAVIORAL

Patients in daily life clinical treatment receiving pharmacological agents to prevent VTE.

Interventions

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No Drug

Patients in daily life clinical treatment receiving pharmacological agents to prevent VTE.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Patients in antithrombotic prophylaxis treatment after total knee/hip replacement. This is an epidemiological study where the patients to be included will be those that are treated with antithrombotics as out-patients in real life conditions.

Exclusion Criteria

* Patients who has been previously treated with injectable antithrombotic treatments.
* Diabetic patients treated with insulin.
* Patients who do not sign Informed Consent Form.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Many Locations, , Spain

Site Status

Countries

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Spain

Other Identifiers

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NN0811ES

Identifier Type: -

Identifier Source: secondary_id

14343

Identifier Type: -

Identifier Source: org_study_id