- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00911001
SALTO - Epidemiological Study on Compliance and Treatment Satisfaction (SALTO)
September 18, 2013 updated by: Bayer
Compliance and Treatment Satisfaction in Prophylaxis of Postsurgical Thromboembolism
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.
Study Overview
Study Type
Observational
Enrollment (Actual)
480
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Many Locations, Spain
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients in antithrombotic prophylaxis treatment after total knee/hip replacement
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Group 1
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Patients in daily life clinical treatment receiving pharmacological agents to prevent VTE.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To measure the Treatment Satisfaction with medication through the self administered scale TSQM.
Time Frame: 2 weeks
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2 weeks
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To measure compliance with medication and the relationship with satisfaction through the Moriski-Green Questionaire
Time Frame: 2 weeks
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2 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2008
Primary Completion (Actual)
March 1, 2009
Study Completion (Actual)
March 1, 2009
Study Registration Dates
First Submitted
May 27, 2009
First Submitted That Met QC Criteria
May 29, 2009
First Posted (Estimate)
June 1, 2009
Study Record Updates
Last Update Posted (Estimate)
September 19, 2013
Last Update Submitted That Met QC Criteria
September 18, 2013
Last Verified
September 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14343
- NN0811ES
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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