SALTO - Epidemiological Study on Compliance and Treatment Satisfaction

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00911001
First received: May 27, 2009
Last updated: September 18, 2013
Last verified: September 2013
  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.


Condition Intervention
Thromboembolism
Behavioral: No Drug

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Compliance and Treatment Satisfaction in Prophylaxis of Postsurgical Thromboembolism

Further study details as provided by Bayer:

Primary Outcome Measures:
  • To measure the Treatment Satisfaction with medication through the self administered scale TSQM. [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To measure compliance with medication and the relationship with satisfaction through the Moriski-Green Questionaire [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Enrollment: 480
Study Start Date: November 2008
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1 Behavioral: No Drug
Patients in daily life clinical treatment receiving pharmacological agents to prevent VTE.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00911001

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

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00911001     History of Changes
Other Study ID Numbers: 14343, NN0811ES
Study First Received: May 27, 2009
Last Updated: September 18, 2013
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Bayer:
Arthroplasty
Antithrombotic prophylaxis treatment
Replacement
Knee

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

ClinicalTrials.gov processed this record on July 24, 2014