SALTO - Epidemiological Study on Compliance and Treatment Satisfaction

Thromboembolism Clinical Trial

— SALTO  

Official title:

Compliance and Treatment Satisfaction in Prophylaxis of Postsurgical Thromboembolism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00911001
• Other study ID #: 14343
• Secondary ID: NN0811ES
• Status: Completed
• Phase: N/A
• First received: May 27, 2009
• Last updated: September 18, 2013
• Start date: November 2008
• Est. completion date: March 2009

Study information

• Verified date: September 2013
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 480
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Thromboembolism

Intervention

Behavioral:
• No Drug
Patients in daily life clinical treatment receiving pharmacological agents to prevent VTE.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To measure the Treatment Satisfaction with medication through the self administered scale TSQM.		2 weeks	No
Secondary	To measure compliance with medication and the relationship with satisfaction through the Moriski-Green Questionaire		2 weeks	No

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