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SALTO - Epidemiological Study on Compliance and Treatment Satisfaction (SALTO)

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ClinicalTrials.gov Identifier: NCT00911001
Recruitment Status : Completed
First Posted : June 1, 2009
Last Update Posted : September 19, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment
Thromboembolism Behavioral: No Drug

Study Design

Study Type : Observational
Actual Enrollment : 480 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Compliance and Treatment Satisfaction in Prophylaxis of Postsurgical Thromboembolism
Study Start Date : November 2008
Primary Completion Date : March 2009
Study Completion Date : March 2009
Groups and Cohorts

Group/Cohort Intervention/treatment
Group 1 Behavioral: No Drug
Patients in daily life clinical treatment receiving pharmacological agents to prevent VTE.


Outcome Measures

Primary Outcome Measures :
  1. To measure the Treatment Satisfaction with medication through the self administered scale TSQM. [ Time Frame: 2 weeks ]

Secondary Outcome Measures :
  1. To measure compliance with medication and the relationship with satisfaction through the Moriski-Green Questionaire [ Time Frame: 2 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients in antithrombotic prophylaxis treatment after total knee/hip replacement
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00911001


Locations
Spain
Many Locations, Spain
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
More Information

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00911001     History of Changes
Other Study ID Numbers: 14343
NN0811ES
First Posted: June 1, 2009    Key Record Dates
Last Update Posted: September 19, 2013
Last Verified: September 2013

Keywords provided by Bayer:
Arthroplasty
Antithrombotic prophylaxis treatment
Replacement
Knee

Additional relevant MeSH terms:
Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases