check_circleStudy Completed

Thromboembolism

Bayer Identifier:

14343

ClinicalTrials.gov Identifier:

NCT00911001

EudraCT Number:

Not Available

EU CT Number:

Not Available
SALTO - Epidemiological study on compliance and treatment satisfaction

Trial purpose

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.

Key Participants Requirements

Sex

Both

Age

18 Years
  • - 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.
  • - Patients who has been previously treated with injectable antithrombotic treatments.
    - Diabetic patients treated with insulin.
    - Patients who do not sign Informed Consent Form.

Trial summary

Enrollment Goal
480
Trial Dates
November 2008 - March 2009
Phase
N/A
Could I Receive a placebo
No
Products
No Drug
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many Locations, Spain

Primary Outcome

  • To measure the Treatment Satisfaction with medication through the self administered scale TSQM.
    date_rangeTime Frame:
    2 weeks
    enhanced_encryption
    Safety Issue:
    no

Secondary Outcome

  • To measure compliance with medication and the relationship with satisfaction through the Moriski-Green Questionaire
    date_rangeTime Frame:
    2 weeks
    enhanced_encryption
    Safety Issue:
    no

Trial design

Compliance and treatment satisfaction in Prophylaxis of postsurgical thromboembolism
Trial Type
Observational
Intervention Type
Behavioral
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

Click here and search for drug information provided by the FDA.Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.Click here to find results for studies related to marketed products.