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Completed

NCT Number: NCT00911001

SALTO - Epidemiological Study on Compliance and Treatment Satisfaction

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.

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Key information

Conditions

Thromboembolism Cardiovascular Diseases Embolism and Thrombosis Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Many Locations, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No Drug

Behavioral

Patients in daily life clinical treatment receiving pharmacological agents to prevent VTE.

Primary outcomes

  1. To measure the Treatment Satisfaction with medication through the self administered scale TSQM.

    Time frame: 2 weeks

Secondary outcomes

  1. To measure compliance with medication and the relationship with satisfaction through the Moriski-Green Questionaire

    Time frame: 2 weeks

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

Compliance and Treatment Satisfaction in Prophylaxis of Postsurgical Thromboembolism

Acronym: SALTO

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jun 1, 2009
Registry last updated
Sep 19, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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